Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients

Phase 3

Recruiting

• Conditions: Metastatic Prostate Cancer; Therapy, Directly Observed
• Interventions: Procedure: Cytoreductive prostatectomy or brachytherapy; Drug: ADT+second-generation antiandrogens ± chemotherapy

• Registration Number: NCT06350825
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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)

Detailed Description

To investigate the multimodality approaches for mHSPC

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2024-03
• Study First Submitted: 2024-03-20
• Study First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Study First Posted: 2024-04-05
• Last Update Posted: 2024-04-05
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local treatment group	Cytoreductive prostatectomy or brachytherapy	Triplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy
SOC group	ADT+second-generation antiandrogens ± chemotherapy	Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)

Primary Outcome Measures

Name	Time	Method
rPFS	3 year	Assess how long a cancer patient lives without any signs of progression of their disease, as determined by radiographic evidence

Secondary Outcome Measures

Name	Time	Method
Safety of CRP in mHSPC patients	until one year after the local therapy	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Trial Locations

Locations (1)

The First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China