Comprehensive Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial, called PROLONG-3, is focused on understanding whether a more extensive radiation treatment for prostate cancer can help patients live longer without their cancer worsening. Specifically, it compares two approaches: one that includes comprehensive radiation to both the prostate and any metastatic areas (where cancer has spread) along with standard systemic therapy, versus a treatment that focuses only on the primary tumor in the prostate, also with standard therapy. The trial will involve 390 men who have a specific type of prostate cancer with up to 10 metastatic spots confirmed by a special imaging test.

To participate in this trial, men must be between 18 and 85 years old and have a confirmed diagnosis of prostate cancer with limited metastases. They should not have received certain prior treatments like chemotherapy, and their overall health must be stable enough to tolerate the study treatments. If accepted, participants will receive either the comprehensive treatment or the standard treatment and will be monitored over time for their cancer progression, overall survival, side effects from the treatment, and quality of life. This trial could provide important information that may change how prostate cancer is treated in the future, potentially leading to better outcomes for patients.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male patients aged 18-85 years.
• • Histopathologically confirmed acinar adenocarcinoma of the prostate. The presence of a minor component of ductal adenocarcinoma, intraductal carcinoma, and/or neuroendocrine differentiation is permitted.
• • PSMA PET performed within 4 weeks prior to the start of study drug therapy or up to 4 weeks after initiation, demonstrating the presence of 1 to 10 metastatic lesions.Metastasis within pelvic lymph nodes (N1 disease) is permitted but not counted towards the total number of metastatic lesions. Metastasis to non-regional lymph nodes is permitted and counted towards the total number.The pelvis is anatomically divided into 4 regions: left hemipelvis (ilium/ischium/pubis), right hemipelvis (ilium/ischium/pubis), sacrum, and coccyx. Multiple lesions within a single anatomical division are aggregated and counted as one metastatic lesion.
• • Prior androgen deprivation therapy (ADT) is permitted if the total duration was ≤ 12 months before enrollment. ADT includes luteinizing hormone-releasing hormone (LHRH) agonists or antagonists and novel hormonal agents (e.g., abiraterone, enzalutamide, apalutamide, darolutamide).
• • Eastern Cooperative Oncology Group (ECOG) score 0-2.
• • Hematology: Neutrophil count \>=1.0×10\^9/L; Platelet count \>=75×10\^9/L; Hemoglobin \>=90 g/L.
• Exclusion Criteria:
• • Small cell carcinoma of the prostate or prostate sarcoma.
• • The primary focus has received external radiation therapy, brachytherapy, and radical prostatectomy.
• • Received non-endocrine systemic therapies prior to enrollment (e.g., chemotherapy, targeted therapy, radionuclide therapy).
• • Metastatic castration-resistant prostate cancer (mCRPC) phase (EAU Guidelines\*).
• • Presence of visceral metastases (e.g., liver, lung).
• • Previous bilateral orchiectomy.
• • Comorbidities: Severe comorbidities affecting survival or treatment tolerance, including: Cardiovascular diseases (NYHA Class III/IV heart failure, uncontrolled arrhythmias); Renal insufficiency (eGFR \<30 mL/min/1.73m\^2); Neuropsychiatric disorders impairing protocol compliance.
• * Definition of mCRPC (EAU Guidelines):
• Metastatic castration-resistant prostate cancer (mCRPC) is defined as disease progression despite serum testosterone levels below 50 ng/dL (or 1.7 nmol/L), concurrently with one or more of the following:
• • 1. PSA progression: A sequence of at least three consecutive rises in PSA, measured ≥1 week apart, resulting in a ≥50% increase from the nadir (lowest) level, with a minimum absolute PSA value \>2 ng/mL.
• 2. Radiographic progression: The appearance of new lesions, defined as either:
• • ≥2 new lesions on bone scan (Tc-99m bone scintigraphy), or
• • New measurable soft tissue lesions according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria.
• • 3. Unequivocal clinical progression: Clinical progression in the absence of concurrent PSA or radiographic progression should be viewed with suspicion and mandates further investigation to confirm disease progression.