CytoREductive prostAtectomy for Poly-metastatic Hormone sensiTIVE Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-85
SponsorRenJi Hospital
About this trial
The goal of this clinical trial is to compare systemic therapy combined with cytoreductive prostatectomy with standard of care (SOC) in de novo poly-metastatic hormone sensitive prostate cancer (de novo pmHSPC). The main questions it aims to answer are:
1. To explore the clinical benefit and safety of systemic therapy combined with cytoreductive prostatectomy for patients with de novo pmHSPC. 2. To explore the characteristics of the subgroup of patients who could benefit more from the above treatment. 3. To explore the relationship between stage efficacy and clinical prognosis. 4. To explore the correlation between molecular imaging such as PSMA-PET/CT and its changes with treatment efficacy.
Participants will undergo systemic therapy combined with cytoreductive prostatectomy.
Researchers will compare systemic therapy combined with cytoreductive prostatectomy with SOC to see the pros and cons of the two strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand the purpose of this trial and sign a written informed consent;
Men aged 18-85 years;
have histologically or cytologically confirmed adenocarcinoma of the prostate;
Have multiple metastatic disease, defined as follows: according to RECIST v1.1, metastatic disease was defined as metastatic foci detected on bone scans or measurable lymph nodes or soft tissue or visceral lesions above the aortic bifurcation. Lymph nodes were defined as measurable if their short-axis diameter was ≥15 mm; soft tissue/visceral lesions were defined as measurable if their long-axis diameter was ≥10 mm. and total number of metastatic lesions ≥ 5. Patients with only regional lymph node metastases (N1, below the aortic bifurcation) were not eligible for the study.
Disqualifiers
Prior therapy: ADT, second-generation androgen receptor inhibitors, CYP17 enzyme inhibitors, any chemotherapy or immunotherapy for prostate cancer, radiotherapy (external radiation radiotherapy, brachytherapy, or radiopharmaceuticals);
Known hypersensitivity to any of the investigational drugs, or excipients in the preparations;
Contraindication to CT/MRI examination;
Any of the following conditions within 6 months prior to randomization: stroke, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, or congestive heart failure (New York Heart Association cardiac function class III or IV);
Trial design
Design model
Parallel
Treatments tested in this trial
Systemic Chemohormonal Therapy
DrugUnder continuous ADT, docetaxel 75mg/m\^2 body surface area every 21 days, oral dexamethasone 7.5mg pretreatment 12h, 3h, 1h before each infusion of docetaxel, and a total of 10mg of prednisolone per day when needed according to the decision of the researcher (in the case of grade 3 and above neutropenia or peripheral edema); oral darolutamide 600mg twice per day, 21 days for one cycle, six cycles in total.
Systemic Hormonal Therapy
DrugUnder continuous ADT, oral darolutamide 600mg twice per day
Cytoreductive Prostatectomy
Procedure/SurgeryCytoreductive prostatectomy was performed after six cycles of neoadjuvant systemic chemohormonal therapy.
Postoperative Adjuvant Radiotherapy
Procedure/SurgeryPostoperative adjuvant radiotherapy of prostate bed is performed, if margin positive, with conventional segmentation and the dose of 64-72Gy.
Treatment groups
192 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 4 interventions
Group B: Control groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Castration resistant-free survival
From date of randomization to the date of the following events, whichever occurs first: prostate specific antigen (PSA) elevation above nadir of at least 2 ng/mL or elevation above nadir of at least 25% when testosterone is at castration level (\<50 ng/dL), as determined by reassessment at least 3 weeks later; or soft tissue, visceral, or radiographic progression of skeletal lesions: as recommended by the Prostate Cancer Clinical Trials Working Group (PCWG)3, Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 is applied via magnetic resonance imaging (MRI) of the thorax/abdomen/pelvis to determine radiographic progression of soft tissue/visceral lesions; bone metastases are identified separately from soft tissue/visceral metastases and are determined by 99mTc methylenediphosphonate bone scanning of the whole body according to PCWG3. Metastases may also be identified using PSMA-PET/CT.
Time frame
Through study completion, assessed up to three years.Secondary outcomes
1
Overall Survival
From date of randomization until the date of death from any cause.
Time frame
Through study completion, assessed up to three years.2
PSA response
Complete remission is defined as PSA detectable (≥0.2 ng/mL) at baseline and undetectable (\<0.2 ng/mL) for the duration of the study; PSA50, and PSA90 response are defined as a ≥50% or ≥90% decrease in the measured PSA level from baseline to post-baseline as determined by reassessment after at least 3 weeks.
Time frame
Through study completion, assessed up to three years.3
Symptomatic skeletal event
Defined as external radiation therapy for the relief of skeletal symptoms, a new symptomatic pathologic fracture or vertebral compression fracture or related orthopedic surgical intervention, or death, whichever occurred first.
Time frame
Through study completion, assessed up to three years.4
Pain progression
Pain is assessed at each visit using the Visual Analogue Scale (VAS). Pain progression is defined as an increase of ≥2 points from the nadir of the worst pain score or opioid use for more than 7 consecutive days in two consecutive assessments ≥4 weeks apart for asymptomatic patients ("worst pain in 24 hours" score of 0 at baseline). For symptomatic patients (worst pain in 24 hours" score \>0 at baseline), pain progression was defined as an increase of ≥2 points from the nadir of the worst pain score on two consecutive assessments ≥4 weeks apart and with a worst pain score of ≥4 or or initiation of short-acting or long-acting opioid therapy for cancer pain for more than 7 consecutive days.
Time frame
Through study completion, assessed up to three years.Other outcomes
1
Pathological and molecular response
Tissue samples are collected and closely examined by pathologists to assess patients' baseline pathological stage as well as their pathological response after induction systemic therapy. Also, tissue samples and paired body fluid samples are retained under appropriate conditions for future exploratory studies (including but not limited to transcriptomics, proteomics, metabolomics sequencing on single-cell and bulk level, SRT and EV-related studies) concerning molecular characteristics and response to therapy. Informed consent form is required prior to collection of above-mentioned samples.
Time frame
At baseline and at the end of the 6th cycle of induction chemohormonal therapy (each cycle is 21 days).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov