NCT06992232RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 28 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 19 May 2025
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Prostate cancer
- NCT number
- NCT06992232
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 144
- From 1 Aug 2024 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Patients with prostatic histopathology exhibiting neuroendocrine, small cell, or sarcomatoid features.
- The researchers assessed the primary lesion as unresectable.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.