[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616195":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":20,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"National Cancer Institute, Naples","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Unfavorable Intermediate-Risk Prostate Cancer","EXPERIMENTAL","This single arm study includes male patients over 18 years of age with histologically confirmed unfavorable intermediate-risk prostate cancer, defined as clinical stage T2b-T2c, PSA ≤ 20 ng\u002FmL, Gleason score 7 (4+3), and ISUP grade 3. Participants must have a prostate volume \\\u003C 80 cc, preserved erectile function (IIEF-5 \\> 8), ECOG performance status 0-1, and no evidence of capsular invasion or metastatic disease (based on multiparametric MRI, PSMA PET, CT with contrast, and bone scan).",[13],"Combination Product: Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Combined Androgen Deprivation Therapy with Relugolix and Image-Guided Stereotactic Body Radiotherapy (SBRT)","Participants will receive oral androgen deprivation therapy (ADT) with Relugolix (120 mg daily for 6 months) and stereotactic body radiotherapy (SBRT) via CyberKnife®. ADT includes a neoadjuvant phase (months 1-3), concurrent SBRT phase (month 4), and adjuvant phase (months 5-6). About 7-10 days before SBRT, 3-4 intraprostatic fiducial markers will be implanted. SBRT consists of 5 fractions of 7.25 Gy (total 36.25 Gy) delivered over two weeks. Planning involves contrast-enhanced CT, with defined CTV and PTV, and sparing of organs at risk. Treatment uses real-time image guidance and motion tracking. The regimen aims to optimize tumor control while minimizing toxicity. Patients are monitored using RTOG criteria, quality of life questionnaires, PSA\u002Ftestosterone levels, and financial toxicity assessments over an 12-month follow-up.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Rossella Di Franco, Radiation Oncologist","CONTACT","+39 08117770569","r.difranco@istitutotumori.na.it",[28],{"facility":29,"status":30,"city":31,"state":20,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale - Napoli","RECRUITING","Naples","80131","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],14.26811,40.85216,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":20,"phoneExt":20,"email":44},"Simona Mercogliano, Study Coordinator","simona.mercogliano@istitutotumori.na.it",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Rossella Di Franco","Principal Investigator - Radiation Oncology","100616195","phase-2-redi-caprecovery-of-erectile-dysfunction-induced-in-prostate-cancer-patients-100616195",false,"NCT07302451","REDI-CaP(Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients)","REDI-CaP (Recovery of Erectile Dysfunction Induced in Prostate Cancer Patients). Innovative Management of Patients With Unfavorable Intermediate-Risk Prostate Cancer: a Special Focus on Quality of Life and Erectile Function Recovery","REDI-CaP","Inclusion Criteria:\n\n* Male sex. (This criterion is required for the patient population being studied and for the correct data structuring in CTIS.)\n* Age \\> 18 years;\n* Diagnosis of prostate cancer via transperineal core biopsy;\n* Classified as unfavorable intermediate-risk (T2b-2c, PSA ≤ 20 ng\u002FmL, and Gleason score 7(4+3); ISUP grade 3);\n* Signed informed consent for REDI-CaP protocol;\n* Signed consent for REDI-CaP data processing;\n* Prostate volume ≤ 80 cc;\n* No evidence of prostate capsule invasion (documented by multiparametric MRI of the prostate);\n* Performance status: 0-1;\n* Negative total-body CT with contrast and bone scan for metastases;\n* Negative PSMA PET for secondary lesions;\n* IIEF-5 score: ≥ 8;\n* Patient compliance with completing periodic questionnaires and attending regular follow-ups as required by the study.\n\nExclusion Criteria:\n\n* Have prostate cancer classified as low-risk, favorable intermediate-risk, or high-risk;\n* Exhibit erectile dysfunction at baseline (IIEF-5 score: \\\u003C 8);\n* Show positive PSMA PET results for metastases or pelvic lymph nodes;\n* Have capsular involvement documented by multiparametric prostate MRI;\n* Have contraindications to radiotherapy and\u002For hormone therapy;\n* Are unable to undergo MRI;\n* Cannot adhere to periodic tests and follow-ups;\n* Refuse or have contraindications to the implantation of intraprostatic fiducials.","MALE","18 Years",{"count":60,"type":61},50,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","The goal of this study is to evaluate the recovery of erectile function at six months after hormonal therapy cessation in male patients affected by advanced prostate cancer and undergoing radiotherapy. The main questions are:\n\n* How well and how quickly do patients recover their sexual function and overall quality of life after stopping hormone therapy and receiving radiotherapy?\n* How do the details of the radiation treatment (like the dose and how it's delivered) relate to treatment success, side effects, and long-term outcomes such as cancer control, survival, and financial impact? Participants will receive hormonal therapy (Relugolix) following by radiotherapy. They will complete questionnaires on sexual function, quality of life, and financial impact before, during and after treatment, and attend follow-up visits for health assessments. The study will measure how many patients recover erectile function within six months of stopping hormonal therapy, how long recovery takes, how treatment doses relate to outcomes, and assess cancer control, side effects, quality of life, and survival.",[67],"Prostate Cancer (Adenocarcinoma)",[69,70,71,72,73,74],"Erectile Function Recovery","Relugolix","Androgen Deprivation Therapy (ADT)","Stereotactic Body Radiotherapy (SBRT)","Cyberknife System","Prostate Cancer","2026-07-20",{"date":77,"type":78},"2026-07-21","ACTUAL",{"date":80,"type":78},"2026-02-23",{"date":82,"type":61},"2031-02-23",{"name":5,"class":6},1]