Clinical trial · Interventional
Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer
Feasibility of Cytoreductive Prostatectomy in Men Newly Diagnosed With Metastatic Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. When combined with hormone therapy, robotic assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy (RRP) may prolong survival in patients with prostate cancer that has spread.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Prostatic Adenocarcinoma | — | UNRESOLVED | — |
| Prostate Carcinoma Metastatic to the Bone | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide) | Drug | — | UNRESOLVED |
| Conventional open retropubic radical prostectomy | Procedure | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Robotic Assisted Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surgery followed by hormone therapy (ADT)
- description
- Patients undergo Robotic Assisted Radical Prostatectomy (RARP) or conventional open retropubic radical prostectomy (RRP). Immediately following surgery, patients receive the standard systemic androgen deprivation therapy.
- interventionNames
- Procedure: Robotic Assisted Radical Prostatectomy
- Procedure: Conventional open retropubic radical prostectomy
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Drug: ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
Primary outcomes (1)
- measure
- Rate of major peri-operative complications defined as Clavien-Dindo grade III or higher
- timeFrame
- Within 90 days after cytoreductive prostatectomy
- description
- Rate will be calculated for the primary end point, and one-sided Binomial test will be used to compare the rate to the hypothesized value. Descriptive statistics will be provided. Any further statistical analysis deemed necessary to calculate significant findings will be done with the assistance of the Rutgers Cancer Institute of New Jersey Biostatistics Section.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma of the prostate * Evidence of lymph node or bone metastasis by magnetic resonance imaging (MRI)/computed tomography (CT), bone scan, or biopsy (N1Mx or NxM1) * Give informed consent * Clinical stage T3 or less (pelvic MRI shows no rectal and ureteral invasion) * Cleared by the primary medical doctor for surgery * No prior systemic therapy for metastatic prostate cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Refuses to give informed consent * Refuses or is unable to have pelvic MRI * Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion) * Deemed a poor surgical risk per primary medical doctor * Received prior therapeutic intervention for metastatic prostate cancer * Known spinal cord compression or brain or liver metastasis * Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months
References
Publications (0)
Data not yet available