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Clinical Trials in China / NCT06992232
Recruiting Phase 2

Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

NCT06992232 · tracked via the Priya Life Science China tracker
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Phase
Phase 2
Started
2024-08-01
Last updated
2025-05-28

Condition(s) studied

Prostate Cancer Metastatic Disease

Investigational drug(s) / intervention(s)

Intense androgen deprivation therapyRadiation Therapyradical prostatectomy

Intense androgen deprivation therapy: Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.

Radiation Therapy: Those allocated radiotherapy received 70Gy/2.8Gy/25f schedule for primary tumor and 70Gy/2.6-2.8Gy/25f or 37.5Gy/7.5Gy/5f for metastatic lymph nodes and bone lesions based on the size and location. Radiation should be finished within 2 years' systemic therapy.

radical prostatectomy: Those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment. Surgery should be finished within 2 years' systemic therapy.

Study summary

This multi-center randomized controlled phase II trial was carried out in several hospitals in China to evaluate the efficacy and safety of radiotherapy or radical prostatectomy combined with intense androgen deprivation therapy for newly diagnosed metastatic prostate cancer.

Eligibility

Sex
MALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Histologically or cytologically confirmed prostate adenocarcinoma, with distant metastasis diagnosed by novel imaging modalities (PSMA PET/CT or PSMA PET/MR), involving ≤10 metastatic sites (amenable to local therapy) and without visceral metastasis. 2. The primary lesion is deemed resectable, or can achieve a resectable state following IADT. 3. Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months. 4. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1. 5. Patients must have adequate hematologic function, hepatic function and renal function. 6. Patients must participate voluntarily and sign an informed consent form(ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol. 7. Fertile patients must be willing to use highly effective contraception during the study period. Exclusion Criteria: 1. Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features. 2. The researchers assessed the primary lesion as unresectable. 3. Patients who had previously received androgen deprivation therapy (including medical or surgical castration) for more than 3 months, or had undergone focal therapy for prostate cancer, or had received radiotherapy or chemotherapy for prostate cancer. 4. Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy. 5. Patients with New York Heart Association (NYHA) Class III/IV congestive heart failure, unstable angina, or a history of myocardial infarction within the past 6 months. 6. Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent pulmonary disease, chronic liver disease, or HIV infection. 7. Within the past 5 years, having had other malignant tumors except for prostate cancer, with the exception of cured basal or squamous cell skin cancer. 8. Suffering from mental illness, mental disability, or being incapable of providing informed consent.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University Nanjing Jiangsu Recruiting

More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06992232 on ClinicalTrials.gov ↗ ← All trials in China