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

Nanjing Medical University

Status and phase: Enrolling; Phase 3

Conditions: Metastatic Prostate Cancer; Therapy, Directly Observed

Treatments: Procedure: Cytoreductive prostatectomy or brachytherapy; Drug: ADT+second-generation antiandrogens ± chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06350825

2023-SR-543

Details and patient eligibility

About

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)

Full description

To investigate the multimodality approaches for mHSPC

Enrollment: 200 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Local treatment group

Experimental group

Description:

Triplet or doublet therapy followed by cytoreductive prostatectomy or brachytherapy

Treatment:

Procedure: Cytoreductive prostatectomy or brachytherapy

SOC group

Active Comparator group

Description:

Triplet or doublet therapy (ie. docetaxel/abiraterone, apalutamide，Rezvilutamide，darolutamide，enzalutamide)

Treatment:

Drug: ADT+second-generation antiandrogens ± chemotherapy