Status:
RECRUITING
Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Collaborating Sponsors:
The First Affiliated Hospital of Soochow University
Peking University First Hospital, Beijing, CHINA
Conditions:
Prostate Cancer Metastatic Disease
Eligibility:
MALE
18-80 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06992232
Start Date
August 1 2024
End Date
July 31 2028
Last Update
May 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China, 210008