Prostate CancerPROLONG-3NCT07015138
Comprehensive Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer
A study testing TRT and NTRT in people with Prostate Cancer and Oligometastatic Prostate Cancer, run by Peking University First Hospital at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Oligometastatic Prostate Cancer
- What is being tested?
- TRT and NTRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 390 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jun 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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:
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Hongzhen Li, +86 13718895126, hongzhen.li@pkufh.com
- Not yet recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Yongheng Li, +86 13810277398, yonghenglee@163.com
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hao Wang, +86 18611207267, wanghaobysy@bjmu.edu.cn
About this study
Official title: A Multicenter, Randomized Controlled Clinical Trial Comparing Comprehensive Radiotherapy Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer
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).
Stratification factors included Gleason score (GS ≤8 vs. GS 9-10) and number of metastases (1-3 vs. 4-10). The primary endpoint was 3-year progression-free survival (PFS), with secondary endpoints encompassing overall survival (OS), intermittent treatment rate, adverse events (CTCAE v5.0), and quality of life (EORTC QLQ questionnaires). To minimize bias, stratified block randomization and blinded endpoint adjudication were implemented, with treatment effects analyzed using Kaplan-Meier survival curves and Cox proportional hazards models.
The study's innovation lies in its definitive evaluation of the added value of comprehensive radiotherapy, combined with exploratory biomarker analyses (including genomic testing) to identify predictive markers of therapeutic response. Should the results demonstrate significant PFS improvement with comprehensive radiotherapy, this would provide high-level evidence to guide clinical practice, potentially influencing treatment guideline updates while optimizing patient quality of life and reducing healthcare burdens.
- Conditions
- Prostate Cancer, Oligometastatic Prostate Cancer
- Being tested
- TRT, NTRT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRTRadiation
Comprehensive metastasis-directed radiotherapy:
- Targets: Primary prostate tumor + all metastatic lesions (≤10 sites confirmed by PSMA PET)
- Concurrent therapy: Standard systemic treatment (ADT + novel hormonal agents)
NTRTRadiation
Standard primary radiotherapy:
- Targets: Prostate primary tumor only
- Concurrent therapy: Same systemic treatment as experimental arm
| Study group | Role | What they receive |
|---|---|---|
| ARM A | Experimental | Comprehensive Radiotherapy + Standard Systemic Therapy Receives: Radiation: TRT |
| Arm B | Active comparator | Primary Radiotherapy + Standard Systemic Therapy Receives: Radiation: NTRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression-free survival (PFS)
Measured: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Secondary outcomes (9)
Time to PSA progression
Measured: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Overall survival (OS)
Measured: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
3-year treatment discontinuation rate
Measured: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Quality of life (QoL)
Measure Tools:
EORTC QLQ-C30 (Version 3.0): Global health status (Items 29-30), functional scales (physical, role, emotional, cognitive, social), and symptom scales (fatigue, pain, nausea, etc.).
Scale Range: 0-100 for all domains. Interpretation: Higher scores = better functioning (global/functional scales) or worse symptoms (symptom scales).
QLQ-PR25: Prostate cancer-specific module (symptoms, treatment side effects, sexual function).
Scale Range: 0-100 for all subscales
Interpretation:
Higher scores = worse symptoms (urinary, bowel, treatment-related). Sexual Activity Subscale: Higher scores = more sexual activity (better functioning).
Sexual Functioning Subscale: Higher scores = worse sexual function (e.g., erectile dysfunction).
Measured: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Adverse events (AEs) / Toxicity
Measured: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Time to initiation of subsequent anti-tumor therapy
Measured: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
3-year treatment discontinuation rate (in patients with normalized testosterone)
Measured: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Radiographic progression-free survival (rPFS)
Measured: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Complete PSA response rate
Definition: According to Prostate Cancer Working Group 3 (PCWG3) criteria, the following conditions must be met:
PSA level decreases to undetectable levels (≤0.2 ng/mL). Confirmed by two consecutive measurements (≥4 weeks apart) with no clinical/radiographic progression (per RECIST 1.1).
Measurement Tools:
PSA Assay Method: Electrochemiluminescence immunoassay (ECLIA) or isotope dilution liquid chromatography-mass spectrometry (ID-LC/MS), with a lower limit of quantification (LLoQ) of 0.02 ng/mL.
Radiographic Confirmation: Exclude disease progression (bone scan/CT/MRI per RECIST 1.1).
Statistical Analysis:
Proportion (%) of patients meeting the above criteria, with two-sided 95% confidence intervals.
Measured: 6 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start1 Jun 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong-zhen Li, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015138
- Sponsor's protocol ID
- PROLONG-3
- Acronym
- PROLONG-3
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Clinical Trial Comparing Comprehensive Radiotherapy Versus Primary Tumor Radiotherapy in Oligometastatic Prostate Cancer
- ClinicalTrials.gov ID
- NCT07015138
- Acronym / sponsor ID
- PROLONG-3 / PROLONG-3
- Conditions
- Prostate Cancer, Oligometastatic Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Stratification factors included Gleason score (GS ≤8 vs. GS 9-10) and number of metastases (1-3 vs. 4-10). The primary endpoint was 3-year progression-free survival (PFS), with secondary endpoints encompassing overall survival (OS), intermittent treatment rate, adverse events (CTCAE v5.0), and quality of life (EORTC QLQ questionnaires). To minimize bias, stratified block randomization and blinded endpoint adjudication were implemented, with treatment effects analyzed using Kaplan-Meier survival curves and Cox proportional hazards models.
The study's innovation lies in its definitive evaluation of the added value of comprehensive radiotherapy, combined with exploratory biomarker analyses (including genomic testing) to identify predictive markers of therapeutic response. Should the results demonstrate significant PFS improvement with comprehensive radiotherapy, this would provide high-level evidence to guide clinical practice, potentially influencing treatment guideline updates while optimizing patient quality of life and reducing healthcare burdens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A | Experimental | Radiation: TRTComprehensive Radiotherapy + Standard Systemic Therapy |
| Arm B | Active comparator | Radiation: NTRTPrimary Radiotherapy + Standard Systemic Therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRTComprehensive metastasis-directed radiotherapy: * Targets: Primary prostate tumor + all metastatic lesions (≤10 sites confirmed by PSMA PET) * Concurrent therapy: Standard systemic treatment (ADT + novel hormonal agents) | Radiation | ARM A |
| NTRTStandard primary radiotherapy: * Targets: Prostate primary tumor only * Concurrent therapy: Same systemic treatment as experimental arm | Radiation | Arm B |
Primary outcome
3-year progression-free survival (PFS)
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
9 secondary outcomes
Time to PSA progression
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Overall survival (OS)
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
3-year treatment discontinuation rate
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Quality of life (QoL)
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Adverse events (AEs) / Toxicity
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Time to initiation of subsequent anti-tumor therapy
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
3-year treatment discontinuation rate (in patients with normalized testosterone)
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Radiographic progression-free survival (rPFS)
Time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months
Complete PSA response rate
Time frame: 6 months after radiotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hong-zhen Li study chair
Peking University First Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRT and NTRT in people with Prostate Cancer and Oligometastatic Prostate Cancer, run by Peking University First Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong-zhen Li (+8613718895126, hongzhen.li@pkufh.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progression-free survival (PFS) (time frame: Post-radiotherapy follow-up at 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.