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Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

NCT06992232 · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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Official title
Radiotherapy or Radical Prostatectomy Combined With Intense Androgen Deprivation Therapy for Newly Diagnosed Metastatic Prostate Cancer: A Multi-center Randomized Controlled Phase II Trial
About this study
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 criteria
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.
Study design
Enrollment target: 144 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-08-01
Estimated completion: 2028-07-31
Last updated: 2025-05-28
Interventions
Drug: Intense androgen deprivation therapyRadiation: Radiation TherapyProcedure: radical prostatectomy
Primary outcomes
  • Event-free Survival (2 years)
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · other
With: The First Affiliated Hospital of Soochow University, Peking University First Hospital, Beijing, CHINA
Contacts & investigators
ContactJunlong Zhuang, PhD · contact · zhuangjl-2008@163.com · +86 15950451917
ContactHongqian Guo, PhD · contact
InvestigatorHongqian Guo, PhD · principal_investigator, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
All locations (1)
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing UniversityRecruiting
Nanjing, Jiangsu, China
Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC · TrialPath