Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

Recruiting now · Phase 2

Conditions studied: Prostate Cancer Metastatic Disease

In brief

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.

Key facts

Study ID

NCT06992232

Run by

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

People needed

144

Starts

2024-08-01

Expected to finish

2028-07-31

Last updated by the study team

2025-05-28

Who can join

Age: 18 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• The primary lesion is deemed resectable, or can achieve a resectable state following IADT.
• Non-castration range (≥50 ng/dl), or the duration of testosterone levels in the castration range is no more than 3 months.
• Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 1.
• Patients must have adequate hematologic function, hepatic function and renal function.
• 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.
• Fertile patients must be willing to use highly effective contraception during the study period.

You may not qualify if…

• Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
• The researchers assessed the primary lesion as unresectable.
• 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.
• Patients with severe or uncontrolled underlying diseases who could not tolerate surgery or radiotherapy.
• 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.
• Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent pulmonary disease, chronic liver disease, or HIV infection.
• 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.
• Suffering from mental illness, mental disability, or being incapable of providing informed consent.

Where it is running

• Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

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