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Compares treatment options for Prostate Cancer
Official title Comprehensive Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer
ClinicalTrials.gov ID: NCT07015138
What this study is testing
- What it's testing
- This study is a multicenter, randomized controlled phase III clinical trial (PROLONG-3) designed to evaluate the survival benefit of comprehensive radiotherapy combined with primary tumor radiotherapy versus primary tumor radiotherapy alone in patients with newly diagnosed oligometastatic prostate cancer. The trial enrolled 390 patients with ≤10 metastatic lesions confirmed by PSMA PET imaging, who were randomized in a 2:1 ratio to either the intervention group (comprehensive radiotherapy + standard systemic therapy) or control group (primary radiotherapy + standard systemic therapy).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85, men only
You may be able to join if
- Male patients aged 18-85 years.
- Histopathologically confirmed acinar adenocarcinoma of the prostate. The presence of a minor component of ductal adenocarcinoma, intraductal...
- 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...
- Prior androgen deprivation therapy (ADT) is permitted if the total duration was ≤ 12 months before enrollment. ADT includes luteinizing...
- Eastern Cooperative Oncology Group (ECOG) score 0-2.
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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...
- 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...
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.