Combining radiotherapy or surgery with intense hormone therapy for advanced prostate cancer

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

This study is testing if combining surgery or radiation with strong hormone therapy can help men with newly diagnosed advanced prostate cancer feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 80 Years
• Sex: Male
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06992232 on ClinicalTrials.gov

What this trial studies

This multi-center randomized controlled phase II trial evaluates the effectiveness and safety of combining radiotherapy or radical prostatectomy with intense androgen deprivation therapy in patients newly diagnosed with metastatic prostate cancer. The study focuses on patients with a limited number of metastatic sites that can be treated locally. Participants will undergo either radiotherapy or surgery alongside hormone therapy to assess outcomes. The trial is conducted across several hospitals in China, aiming to provide insights into optimal treatment strategies for this condition.

Who should consider this trial

Good fit: Ideal candidates include men with histologically confirmed prostate adenocarcinoma and limited metastatic disease who are eligible for local therapy.

Not a fit: Patients with extensive visceral metastasis or those whose primary lesions are not resectable may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes and survival rates for patients with metastatic prostate cancer.

How similar studies have performed: Previous studies have shown promise in combining local therapies with androgen deprivation, suggesting potential for success in this approach.

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.

Where this trial is running

Nanjing, Jiangsu

• Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Principal investigator: Hongqian Guo, PhD — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Study coordinator: Junlong Zhuang, PhD

Conditions Prostate Cancer Metastatic Disease; metastatic prostate cancer; radiotherapy; prostatectomy