Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC
NCT ID: NCT06992232
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
144 participants
INTERVENTIONAL
2024-08-01
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intense androgen deprivation therapy (IADT)
Patients received ADT plus ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years in the Intense androgen deprivation therapy (IADT) group.
Intense androgen deprivation therapy
Patients received ADT plus second-generation ARi (enzalutamide, apalutamide, darolutamide or rezvilutamide) for 2 years.
Radiotherapy or Surgery plus IADT
For patients in the experimental group, local treatment either radiotherapy or surgery was arranged in addition to systemic ADT plus ARi. 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. While those allocated surgery received robot-assisted laparoscopic radical prostaectomy plus extended pelvic lymph node dissection for local treatment.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
MALE
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
Peking University First Hospital, Beijing, CHINA
UNKNOWN
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Hongqian Guo
Chief physician
Principal Investigators
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Hongqian Guo, PhD
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Locations
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Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Hongqian Guo, PhD
Role: CONTACT
Facility Contacts
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Other Identifiers
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IUNU-PC-122
Identifier Type: -
Identifier Source: org_study_id
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