Clinical trial · Interventional
Therapeutic Effect of Cytoreductive Radical Prostatectomy in Men With Newly Diagnosed Metastatic Prostate Cancer
SIMCAP (Surgery in Metastatic Carcinoma of Prostate): Phase 2.5 Multi-Institution Randomized Prospective Clinical Trial Evaluating the Impact of Cytoreductive Radical Prostatectomy Combined With Best Systemic Therapy on Oncologic and Quality of Life Outcomes in Men With Newly Diagnosed 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 is a phase 2.5 international, multi-institution, randomized clinical trial to evaluate the potential therapeutic effect of CRP combined with the BST in men with mPCa prospectively. Such hybrid design permits the inclusion of the patients who have accrued to the phase 2 investigation to phase 3 trial, thereby decreasing the number of patients needed overall (5-7). In the initial phase 2 study, we plan to accrue 190 patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IV Prostate Adenocarcinoma AJCC v7 | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antiandrogen Therapy | Drug | — | UNRESOLVED |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Procedure | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Control Group)
- description
- BST - to be determined by the treating physician. Currently, BST is permanent ADT +/- docetaxel (1-3). In patients who were treated with ADT ≥ 1 month prior to randomization, docetaxel, if chosen by the provided, will be given as soon as feasible. In men not treated with ADT or for a duration less than or equal to one month prior to randomization, ADT will be given for a minimum of one month prior to docetaxel therapy. All forms of ADT are allowed. The regimen will be at the discretion of the treating physician. Docetaxel regimen will be at the discretion of the provider. At the time of disease progression, the patient will come off the study treatment phase and enter into follow up. The next line of therapy will be at the discretion of the provider.
- interventionNames
- Drug: Antiandrogen Therapy
- Drug: Docetaxel
- Other: Laboratory Biomarker Analysis
- Procedure: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (Experimental)
- description
- CRP+BST. Patients will undergo surgery if the duration of ADT is greater than one month prior to surgery. In men who have not been treated with ADT or received ADT less than or equal to one month prior to entering the study, ADT will be initiated or continued to ensure that the patients have been treated with ADT for at least one month prior to CRP. Docetaxel must be administered, if selected, prior to surgery. Following surgery, ADT will be continued. Although the surgical approach is at the discretion of the surgeon, robot assistance is the preferred primary approach. At the time of disease progression, the patient will come off the study treatment phase and enter into follow up. The next line of therapy will be at the discretion of the provider.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven adenocarcinoma of the prostate * Evidence of metastasis by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histologic confirmation * Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (solid organ metastasis. * If solitary lesion, metastasis confirmed with either biopsy or two independent imaging modalities (i.e. CT and PET \[positron emission tomography\], bone scan and MRI, modality at the discretion of the treating physician) * No previous local therapy for prostate cancer (i.e prostate radiation, cryotherapy, etc.) * Give informed consent * Prostate deemed resectable by surgeon * Plans to start or has already started ADT no longer than 6 months prior to consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Hemoglobin (HgB) \>= 9 g/dL compatible for surgery * Platelets \> 80,000/mcL compatible for surgery * Aspartate aminotransferase (AST) =\< 2x upper limit of normal (ULN) compatible for surgery * Alanine aminotransferase (ALT) =\< 2x upper limit of normal (ULN) compatible for surgery Exclusion Criteria: * Refuses to give informed consent * Deemed to have unresectable disease by surgeon * Received ADT for more than 6 months prior to consent * Life expectancy of less than 6 months prior to consent * Active spinal cord compression * Deep vein thrombosis (DVT) / pulmonary embolism (PE) in the past 6 months prior to consent * Previous local therapy for prostate cancer * Patients who have chemotherapy or radiotherapy for non-prostate cancer related treatment within 3 weeks prior to consent
References
Publications (0)
Data not yet available