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RECRUITINGPhase 2INTERVENTIONAL

Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. diagnosed by tissue sample (biopsy-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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Intense androgen deprivation therapy

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

RADIATION

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.

PROCEDURE

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.

Locations (1)

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