Clinical trial · Interventional
Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
NCT06350825CI-TRIAL-00075764recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)
Conditions
Conditions (2)
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 Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Therapy, Directly Observed | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADT+second-generation antiandrogens ± chemotherapy | Drug | — | UNRESOLVED |
| Cytoreductive prostatectomy or brachytherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Local treatment group
- description
- Triplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy
- interventionNames
- Procedure: Cytoreductive prostatectomy or brachytherapy
- type
- ACTIVE_COMPARATOR
- label
- SOC group
- description
- Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)
- interventionNames
- Drug: ADT+second-generation antiandrogens ± chemotherapy
Primary outcomes (1)
- measure
- rPFS
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male aged ≥18 and ≤75; 2. Histologically confirmed prostate adenocarcinoma; 3. Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology; 4. Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis); 5. Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.); 6. The surgeon believes the prostate can be removed; Exclusion Criteria: 1. The surgeon believes the disease is unresectable; 2. Life expectancy less than 2 years; 3. Active spinal cord compression; 4. History of prior local treatment for prostate cancer; 5. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption; 6. Refusal to sign the informed consent; 7. Investigator believes the individual is not suitable for inclusion.
References
Publications (0)
Data not yet available
No reference posted for this study.