[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100648087","phase-2-genitourinary-tumors-with-sacituzumab-tirumotecan-100648087",false,"NCT07716917","Genitourinary Tumors With Sacituzumab Tirumotecan","RINGQUEST: Exploring Understudied Genitourinary Tumors With Sacituzumab Tirumotecan; a Single-arm, Basket, Phase II Study","RINGQUEST","Inclusion Criteria:\n\nInformed Consent\n\n1. The participant provides written informed consent for the study.\n2. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.\n\n   Disease Characteristics\n3. Histologically confirmed diagnosis of metastatic or locally advanced unresectable:\n\n   * Cohort 1: papillary renal carcinoma (pRCC).\n   * Cohort 2: variant histology urothelial carcinoma (VH-UC) including the following subtypes:\n\n   nested, microcystic, micropapillary, lymphoepithelioma-like, plasmacytoid, giant cell, poorly differentiated, lipid-rich, clear cell, sarcomatoid) bladder cancer and non-urothelial bladder cancer of epithelial origin including squamous cell carcinoma and adenocarcinoma (urachal and non-urachal).\n\n   Note: Variant histology tumors and non-urothelial tumors of ureter, urethra, urachus, or renal pelvis are included.\n\n   Note: Patients with mixed cell type are eligible if the predominant histology (over 50%) is variant or non-urothelial. All histological classifications will follow the 2022 world health organization (WHO) Classifications.\n4. Disease progression after standard treatment or lack of available standard treatment options:\n\n   * Cohort 1: Prior treatment with PD-1\u002FPD-L1 and or tyrosine kinase inhibitors (TKIs)\n   * Cohort 2: Disease progression after standard treatment. Some VH such as micropapillary, small cell, and sarcomatoid variants are considered highly aggressive and no standard treatments are clearly defined, being considered an orphan disease, so they might be included in the first line in case of lack of available standard treatment options.\n5. Has measurable disease per RECIST 1.1 as assessed by the local site investigator\u002Fradiology.\n\n   Note: Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.\n\n   Demographics\n6. Is an individual of any sex\u002Fgender and is at least 18 years of age at the time of providing the informed consent.\n\n   Patient Status\n7. Has an eastern cooperative Oncology Group Performance status (ECOG PS) of 0 - 1.\n8. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo).\n\n   Note: Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.\n9. Adequate organ function. Specimens must be collected within 10 days before the start of study intervention:\n\n   absolute neutrophil count (ANC) ≥1500\u002FµL \\* Platelets ≥100,000\u002FµL Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL \\* Measured or calculated creatinine clearance (CrCl) ≥30 mL\u002Fmin Total bilirubin ≤1.5 × upper limit normal (ULN) OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Albumin ≥3.0 g\u002FdL \\*\\* international normalized ratio (INR) or prothrombin time (PT) \u002F activated patial thromboplastin (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n\n   \\* without colony-stimulating factors, erythropoietin dependency, and without packed red blood cell (pRBC) transfusion within the preceding 2 weeks.\n\n   \\*\\* without albumin supplementation within the last 72 hours.\n10. Has provided an archival tumor tissue sample or most recently obtained core, incisional, or excisional biopsy of a tumor lesion from any site (primary or metastasis) not previously irradiated. Sites should follow local guidelines regarding fresh tissue collection. Tissue is required for determination of TROP-2 status by the central laboratory. No central pathological review and TROP-2 expression level assessment will be needed to include the patient in the trial.\n11. HIV-infected participants must have well-controlled HIV on antirretroviral therapy (ART), defined as:\n\n    * Having a CD4+ T-cell count ≥350 cells\u002Fmm3 at the time of screening\n    * Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the lower limit of quantification using the locally available assay, at the time of screening and for at least 12 weeks before screening\n    * Absence of any AIDS-defining opportunistic infections within the past 12 months\n    * Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before randomization and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers\u002Finhibitors\u002Fsubstrates.\n    * HIV testing at screening is not required unless:\n\n    There is a known history of HIV infection Mandated by local guidelines\n12. Participants who are HBsAg positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load before randomization.\n\n    Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n\n    \\- Hepatitis B testing at screening is not required unless: There is a known history of HBV infection Mandated by local guidelines\n13. Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\n    Note: Participants must have completed curative antiviral therapy at least 4 weeks before randomization.\n\n    \\- Hepatitis C testing at screening is not required unless: There is a known history of HCV infection Mandated by local guidelines\n\n    Male Participants\n14. If capable of producing sperm, the participant agrees to the following during the intervention period and for at least 120 days after the last dose of sacituzumab tirumotecan:\n\n    * Refrains from donating sperm.\n    * Uses a penile\u002Fexternal condom when having penile-vaginal intercourse with a nonparticipant of childbearing potential who is not currently pregnant plus partner use of an additional contraceptive method, as a condom may break or leak.\n\n    Note: If the participant is azoospermic (vasectomized or secondary to medical cause, documented from the site personnel's review of the participant's medical records, medical examination, or medical history interview), no contraception is required.\n\n    Female Participants\n15. A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n    * Is not a women of childbearing potential (WOCBP) OR\n    * Is a WOCBP and:\n\nHas a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\nMedical history, menstrual history, and recent sexual activity has been reviewed by the physician investigator to decrease the risk for inclusion of a WOCBP with an early undetected pregnancy.\n\nThe participant agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore eggs during this period for the purpose of reproduction.\n\nUses a contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 210 days after the last dose of sacituzumab tirumotecan.\n\nNote: The physician investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by WOCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n\nAbstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. Symptomatic brain metastases or leptomeningeal disease. Note: Participants with previously-treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during study screening, are clinically stable, and have not required steroid treatment for at least 14 days before the first dose of study intervention.\n2. Has an active infection requiring systemic therapy other than those permitted in the inclusion criteria.\n3. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n4. Has a history of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002Finterstitial lung disease or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening\n5. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of cardiac QT interval corrected by Fridericia formula (QTcF) to \\>480 ms, and\u002For other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.\n6. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n   Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.\n\n   Note: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and prostate specific antigen \\\u003C10 ng\u002FmL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n7. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating physician investigator.\n\n   Prior\u002FConcomitant Therapy\n8. Received prior treatment with a TROP-2-targeted antibody drug conjugate (ADC).\n9. Received prior treatment with a topoisomerase 1 inhibitor-containing ADC.\n10. Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.\n11. Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and\u002For has had radiation pneumonitis.\n\n    Note: Two weeks or fewer of palliative radiotherapy for non-central nervous system disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n12. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n13. Is currently receiving a strong inducer\u002Finhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.\n\n    Prior\u002FConcurrent Clinical Study Experience\n14. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.\n15. Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n\n    Other Exclusions\n16. Severe hypersensitivity (Grades ≥3) to study intervention, any of their excipients, and\u002For to another biologic therapy.\n17. Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n\nNote: Participants who underwent major surgery must have adequately recovered from toxicity and\u002For complications from the surgery before starting study intervention.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","RINGQUEST is a Phase 2, open-label, single arm, basket, investigator-initiated clinical trial of sacituzumab tirumotecan in patients with:\n\n* Cohort 1: papillary renal carcinoma (pRCC).\n* Cohort 2: less frequent bladder tumors such as variant histology urothelial carcinoma (VH-UC). The most common VH-UC are nested, microcystic, micropapillary, lymphoepithelioma-like, plasmacytoid, giant cell, poorly differentiated, lipid-rich, clear cell, sarcomatoid) bladder cancer and non-urothelial bladder cancer of epithelial origin including squamous cell carcinoma and adenocarcinoma (urachal and non-urachal).",[27,28],"Papillary Renal Carcinoma","Variant Histology Urothelial Carcinoma","NOT_YET_RECRUITING","2026-07-21",{"date":32,"type":33},"2026-07-23","ACTUAL",{"date":35,"type":21},"2026-10",{"date":37,"type":21},"2029-12",{"name":39,"class":40},"Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":67,"locationsCount":68},"100648111","phase-2-radium-223-for-high-volume-metastatic-hormone-sensitive-prostate-cancer-100648111","NCT07717099","Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer","Quantitative Unified Assessment of Novel Triplet Therapy and Unconventional Maintenance With Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer: A Phase II Pilot Trial","GUARD-QUANTUM","INCLUSION CRITERIA\n\nSubjects must fulfill all of the following inclusion criteria to be eligible for enrollment to the study:\n\n1. Patients must be fully informed about the study and sign the informed consent form (ICF) before any study specific assessment.\n2. Patients ≥18 years old.\n3. ECOG performance status of 0 to 2 and Charlson score ≤ 3 prior to study entry, after docetaxel.\n4. Patients with histologically or cytologically confirmed diagnosis of prostate adenocarcinoma.\n5. Patients should have received triplet therapy with ADT (luteinizing hormone releasing hormone analogue (LHRHA) for continuous treatment or previous bilateral orchidectomy), docetaxel and darolutamide as first-line therapy for mHSPC. The following conditions apply:\n\n   1. Received ≥ 4 cycles of docetaxel.\n   2. Treatment with docetaxel should be finished ≤ 12 weeks before the first planned dose of Ra223.\n   3. Having no progression of the disease after triplet therapy completion and before inclusion.\n\n   Note: patients with prior therapies for locoregional disease are acceptable\n6. Patients should have recovered from any prior toxicity from ADT, darolutamide or docetaxel to CTCAE grade 1 or baseline levels.\n7. Presence of at least 4 bone metastasis on the screening bone scan, with or without lymph node and\u002For visceral metastases.\n8. Asymptomatic or mildly symptomatic (defined as short form question #3 in Brief Pain Inventory worst pain must be \\\u003C 4).\n9. Patients should be willing to initiate or continue bisphosphonates \u002Fdenosumab, calcium and vitamin D supplements (Section 7.4.4) prior to the first dose of Ra223.\n\n   Note: Patients must start treatment with a bone protecting agent (at doses used to reduce the incidence of skeletal related events) before the time of signing the ICF. A minimum of two doses is recommended before the first administration of Ra223. The first administration of Ra223 should be scheduled at least 6 weeks after the first administration of the bone protecting agent.\n10. T-score ≥ -2.5 on a DXA scan done in the past 12 months. A DXA scan performed during the screening period will be encouraged but not mandated.\n11. Adequate organ and bone marrow function as follows (subject must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory):\n\n    1. Absolute neutrophil count (ANC) ≥ 1.5 x109\u002FL;\n    2. Platelets ≥ 100 x109\u002FL;\n    3. Hemoglobin ≥ 9.0 g\u002Fdl;\n    4. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN), except for patients with Gilbert's disease ≤ 5.0 x ULN;\n    5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;\n    6. Creatinine ≤ 1.5 x ULN;\n    7. CrCl \\\u003C 30 mL\u002Fmin;\n    8. Albumin \\> 25 g\u002FL.\n12. Participants who have pregnant partners must use a condom and those with partners of childbearing potential must use a condom and another adequate birth control measure if engaging in sexual activities during the study treatment period and for at least 1 week after last dose of darolutamide and 6 months after the last dose of Ra223. A highly effective method of birth control is defined as those which result in low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n\nEXCLUSION CRITERIA:\n\nSubjects with any of the following could not enroll in this study:\n\n1. Presence of tumor lesion in central nervous system through radiologically confirmed diagnosis.\n2. Prior history of malignancies other than prostate adenocarcinoma (except patients with basal cell, squamous cell carcinoma of the skin, in-situ carcinoma or low-grade superficial bladder cancer, or the patient has been free of malignancy for a period of 3 years prior to inclusion).\n3. Patients experiencing progression during previous ADT or meeting criteria for castration resistant prostate cancer (CRPC).\n\n   Note: Prior ADT is allowed.\n4. External irradiation, brachytherapy, or local treatment (including radiofrequency ablation, cryotherapy, high intensity focused ultrasound, etc.) within 4 weeks prior to the first dose of study treatment.\n5. Received prior chemotherapy for prostate cancer other than as part of first-line triplet therapy for mHSPC.\n6. Major surgery within 4 weeks prior to treatment.\n7. Prior hemibody external radiotherapy.\n8. Corticosteroids are allowed only at a dose ≤ 10 mg of prednisone (or equivalent) no matter the indication.\n9. Receiving abiraterone treatment as part of the first-line triplet therapy for mHSPC.\n\n   Note: An increased risk of death and fractures was observed in a clinical study in which Ra223 was added to abiraterone acetate and prednisone\u002Fprednisolone in patients with asymptomatic or mildly symptomatic CRPC and this is the rationale to not include patients with this combination.\n10. Plan to receive any other antitumor therapies during this trial.\n11. Treatment with an investigational drug within the previous 4 weeks, or planned during the treatment period.\n12. Any other serious illness or medical condition such as, but not limited to:\n\n    1. Any uncontrolled infection ≥ Grade 2 according to NCI-CTCAE v6.0;\n    2. Gastrointestinal disorder affecting absorption (e.g., gastrectomy or active peptic ulcer disease);\n    3. Crohn's disease or ulcerative colitis;\n    4. Osteonecrosis of the jaw;\n    5. Non-malignant bone disease with an osteoblastic activity;\n    6. Bone marrow dysplasia;\n    7. Fecal incontinence;\n    8. Life-threatening illness unrelated to cancer.\n13. Significant cardiovascular disease including:\n\n    1. Uncontrolled angina within 3 months prior to screening;\n    2. Congestive heart failure New York Heart Association (NYHA) class III or IV, or patients with history of congestive heart failure NYHA class III or IV in the past, unless a screening echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months results in a left ventricular ejection fraction that is ≥ 45%. Of note, MUGA scans at baseline will not be mandated.\n    3. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes);\n    4. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place;\n    5. Uncontrolled hypertension as indicated by a resting systolic blood pressure \\> 160 millimeters of mercury (mm Hg) or diastolic blood pressure \\> 100 mm Hg at screening; Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to inclusion. Blood pressure must be re-assessed on two occasions that are separated by a minimum of 1 hour. The mean SBP \u002F DBP values from each blood pressure assessment must be ≤ 160\u002F100 mm Hg in order for a patient to be eligible for the study.\n14. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs. No known hypersensitivity to Ra223 (refer to summary of product characteristics \\[SmPC\\]).\n15. Contraindication to both CT and MRI contrast agents.\n16. Contraindications for the use of bisphosphonates or denosumab as per physician judgment.\n17. Involvement in another therapeutic trial involving an experimental drug.\n18. Drug or alcohol abuse.\n19. Any medical condition that in the opinion of the investigator will negatively affect patients' clinical status when participating in this trial.","MALE",{"count":52,"type":21},50,[24],"GUARD-QUANTUM is a prospective, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study. The rationale behind studying this combination lies in the potential additive or synergistic benefits that may arise from concurrently targeting androgen receptor signaling pathways and bone metastases.",[56],"Metastatic Hormone-Sensitive Prostate Cance",[58,59,60,61],"Ra-223","Prostate cancer","hormone-sensitive","Androgen Pathway Modulation-Sensitive","2026-07-16",{"date":30,"type":33},{"date":65,"type":21},"2026-09",{"date":37,"type":21},{"name":39,"class":40},12,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100618549","phase-3-phase-iii-randomized-international-open-label-clinical-trial-of-treatment-intensification-with-docetaxel-plus-apalutamide-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-who-did-not-achieve-a-deep-psa-response-after-initial-treatment-with-apalutamide-reinforce-trial-100618549","NCT07333066","Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial.","REINFORCE","Inclusion Criteria:\n\n1. Written informed consent. Each patient must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures, required for the study, and is willing to participate in the study.\n2. Patient must be a man ≥18 years of age.\n3. Histologically or cytologically confirmed adenocarcinoma of prostate.\n4. Metastatic hormone-sensitive prostate cancer.\n5. PSA \\>5 ng\u002Fml at diagnosis of metastatic disease.\n6. Patients eligible to continue treatment with apalutamide and ADT and without contra-indication to receive docetaxel.\n7. Patients with at least 24 weeks and no more than 30 weeks of apalutamide.\n8. Patients with a maximum of 12 weeks ADT before apalutamide initiation.\n9. Lack of achievement of deep PSA response after 24 weeks and no more than 30 weeks of apalutamide. Deep PSA response is defined as PSA ≤ 0.2 ng\u002Fml or PSA response ≥ 90% in combination with a PSA ≤4 ng\u002Fml. Therefore, a non-deep PSA response is defined as PSA \\> 0.2 ng\u002Fml in combination with a PSA response \\\u003C 90%, or a PSA response ≥90% in combination with a PSA \\> 4 ng\u002Fml.\n10. Patients who have not progressed to apalutamide.\n11. Patients that are tolerating adequately apalutamide 240 mg daily and with no toxicity higher than G1 at inclusion.\n12. Be able to swallow whole apalutamide film-coated tablets.\n13. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n14. Clinical laboratory values at screening:\n\n    1. hemoglobin ≥10.0 g\u002FdL,\n    2. absolute neutrophil count ≥1.5 × 10\\*9\u002FL,\n    3. platelet count ≥100 × 109\u002FL, The patient must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory sample obtained at screening\n    4. serum alanine aminotransferase and\u002For aspartate transaminase ≤1.5 × the upper limit of normal (ULN),\n    5. total bilirubin ≤ ULN,\n    6. creatinine ≤2.0 × ULN\n15. Sexually active men must agree to use an external condom as an effective barrier method and refrain from sperm donation, and their female partners of childbearing potential must practice a highly effective method of contraception during and for 3 months after treatment with apalutamide and for 6 months after treatment with docetaxel.\n\nExclusion Criteria:\n\n1. Presence of neuroendocrine histology.\n2. Apalutamide treatment started more than 30 weeks before inclusion.\n3. Progression disease by any means, including radiographic, clinical or serological at inclusion.\n4. Patient who achieves deep PSA response on apalutamide treatment before randomization.\n5. Previous androgen-pathway receptor inhibitors, including enzalutamide, darolutamide, abiraterone or other ARPI. Previous treatment with first generation antiandrogens (i.e. bicalutamide) is allowed.\n6. Chemotherapy or immunotherapy for prostate cancer before randomization.\n7. Treatment with radiotherapy (external-beam radiation therapy, brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization.\n8. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs.\n9. Contraindication to both computed tomography and magnetic resonance imaging contrast agent.\n10. Prolonged QT interval defined as QTcF ≥ 480 ms at screening, based on the mean of triplicate 12-lead ECGs performed after at least 5 minutes of rest. Patients with congenital long QT syndrome will also be excluded.\n11. Any of the following within 6 months before randomization:\n\n    1. stroke,\n    2. myocardial infarction,\n    3. severe or unstable angina pectoris,\n    4. uncontrolled arrhythmia,\n    5. coronary or peripheral artery bypass graft, or\n    6. congestive heart failure (New York Heart Association class III or IV)\n12. Peripheral neuropathy ≥ grade 2.\n13. Uncontrolled hypertension, indicated by resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg despite medical management.\n14. Prior malignancy, except for adequately treated basal-cell or squamous-cell carcinoma of the skin or superficial bladder cancer that had not spread behind the connective-tissue layer (i.e., stage pTis, pTa, or pT1) or any cancer for which treatment had been completed ≥5 years before randomization and from which the patient was disease-free.\n15. A gastrointestinal disorder or procedure that was expected to interfere significantly with absorption of study drug.\n16. Active viral hepatitis, known human immunodeficiency virus infection with detectable viral load, or chronic liver disease requiring treatment.\n17. Previous (within 28 days before the start of study drug or 5 half-lives of the investigational treatment of the previous study, whichever was longer) or concomitant participation in another clinical study with investigational medicinal products.\n18. Any other serious or unstable illness or medical, social, or psychological condition that could jeopardize the safety of the patient and\u002For their compliance with study procedures or might interfere with their participation in the study or evaluation of the study results.",{"count":77,"type":21},320,[79],"PHASE3","This is a phase III, randomized, open-label, multi-center study to assess the efficacy of treatment intensification with docetaxel plus apalutamide and ADT, assessed by event-free survival, in patients with mHSPC who do not achieve deep PSA response (≤0,2 ng\u002Fml or PSA90 response in combination with a PSA ≤ 4 ng\u002Fml) after initial treatment with apalutamide and ADT. A non-deep PSA response is defined as PSA \\> 0.2 ng\u002Fml in combination with a PSA response \\\u003C 90%, or a PSA response ≥90% in combination with a PSA \\> 4 ng\u002Fml.",[82],"Metastatic Hormone-sensitive Prostate Cancer",[84,85,86,87],"Prostate Cancer","Apalutamide","Hormone-sensitive prostate cancer","Deep PSA response","RECRUITING","2026-06-15",{"date":91,"type":33},"2026-06-17",{"date":93,"type":33},"2026-06-05",{"date":95,"type":21},"2030-03-31",{"name":39,"class":40},56,""]