Prostate CancerPRESELNCT07115992
Efficacy and Safety of Radical Prostatectomy (RP) With or Without Salvage Radiotherapy Versus RP With Extended Pelvic Lymph Node Dissection for Localized Intermediate- and High-risk Prostate Cancer With a Briganti Nomogram≥7%
A study testing RARP±SRT and RARP+ePLND in people with Prostate Cancer and Prostate Adenoma, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate efficacy and safety of radical prostatectomy (RP) with or without salvage radiotherapy versus RP with extended pelvic lymph node dissection (ePLND) in males who have localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenoma
- What is being tested?
- RARP±SRT and RARP+ePLND
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 29 Feb 2028
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provided signed and dated informed consent form.
- Be male aged 18-80 years at consent.
- Commit to protocol compliance and complete all study procedures.
- Medically fit to tolerate interventions, including PSMA PET imaging, RARP, pelvic radiotherapy.
- Diagnosis of localized intermediate/high-risk prostate cancer (miN0M0):
- Confirmed by: systematic biopsy + PSA + PSMA PET/MRI. ii. Briganti nomogram (2017)≥7%. iii. Candidate for radical prostatectomy. iv. D'Amico:
- Intermediate-risk: PSA 10-20ng/mL OR Gleason 7 (ISUP Grade 2/3) OR cT2b;
- High-risk: PSA>20ng/mL OR Gleason>7 (ISUP Grade 4/5) OR cT2c.
Who cannot join
- Prior treatments for prostate cancer, including radiotherapy, chemotherapy or endocrine therapy.
- Non-acinar adenocarcinoma histology on biopsy.
- Preoperative evidence of metastasis: nodal(N1), locally advanced(T3-4), or distant(M1) disease on imaging.
- History of pelvic lymphadenectomy or radiotherapy.
- Other malignancies within 5 years.
- Contraindications to radical prostatectomy or being deemed surgically inoperable upon clinical assessment.
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- Contraindications to radiotherapy or intolerance determined by radiation oncologists.
- Severe allergy to PSMA PET ligands or excipients.
- Any other conditions precluding PSMA PET examination.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin hospital
Shanghai, 221000
Xu, +86-13901734568, xdf12036@rjh.com.cn
About this study
Official title: Efficacy and Safety of Radical Prostatectomy (RP) With or Without Salvage Radiotherapy Versus RP With Extended Pelvic Lymph Node Dissection for Localized Intermediate- and High-risk Prostate Cancer With a Briganti Nomogram≥7%: an Open-label, Single-center, Non-inferiority Randomized Controlled Study
The goal of this clinical trial is to evaluate efficacy and safety of radical prostatectomy (RP) with or without salvage radiotherapy versus RP with extended pelvic lymph node dissection (ePLND) in males who have localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%. The main questions this study aim to answer are:
- Is RP with or without salvage radiotherapy non-inferior to RP with ePLND in efficacy for patients with localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%?
- Will complication rates of RP with or without salvage radiotherapy be significantly lower than those of RP with ePLND?
Read more
Researchers will compare the experimental arm (robot-assisted laparoscopic radical prostatectomy with or without salvage radiotherapy) versus the control arm (robot-assisted laparoscopic radical prostatectomy with ePLND) to see if differences exist in oncological efficacy and safety outcomes.
Participants will:
- Undergo one of the following surgical interventions:
- Robot-assisted laparoscopic radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), OR
- RARP alone, followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively
- Complete scheduled monitoring activities:
- Serum PSA testing: Monthly or every 3 months within 2 years after surgery
- PSMA PET/CT scans: Annually until study completion
- Report all treatment-related complications within 24 hours of onset
- Conditions
- Prostate Cancer, Prostate Adenoma
- Being tested
- RARP±SRT, RARP+ePLND
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RARP±SRTProcedure or surgery
Participants will undergo robot-assisted radical prostatectomy (RARP). Upon biochemical recurrence, they will receive salvage radiotherapy: 52.5-62.5 Gy in 20-25 fractions/2.5-3.0 Gy per fraction, per 2025 AUA/ASTRO/SUO guidelines.
RARP+ePLNDProcedure or surgery
Participants will undergo robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), encompassing bilateral removal of obturator, external iliac, internal iliac, and common iliac lymph nodes. The dissection field extends laterally to the genitofemoral nerve, medially to the bladder wall, proximally to the ureter crossing the common iliac vessels, and distally to the deep circumflex iliac vein and femoral canal.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants in the experimental group will receive robot-assisted laparoscopic radical prostatectomy (RARP), followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively. Receives: Procedure: RARP±SRT |
| Control group | Active comparator | Participants in the control group will receive RARP with extended pelvic lymph node dissection, per guideline recommendations. Receives: Procedure: RARP+ePLND |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Biochemical-recurrence Free Survival rate (2-year BFS)
The 2-year biochemical recurrence-free survival rate (2-year BFS) will be recorded from randomization. Biochemical recurrence (BCR) is defined as serum PSA≥0.2ng/mL confirmed by at least one repeat test >6 weeks postoperatively. Time to first BCR event is measured:
- For control group: After RARP completion.
- For experimental group: After salvage radiotherapy completion.
Measured: 2 years from randomization
Secondary outcomes (4)
PSA doubling time, PSADT
Measured: baseline and 2 years
Radiographic progression-free survival, rPFS
Measured: 2 years from randomization
Time to First biochemical recurrence (BCR) event in the experimental group
Measured: 2 years from randomization
Overall survival, OS
Measured: 2 years from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start30 Jul 2025
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (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 Ruijin 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
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115992
- Sponsor's protocol ID
- 2025-423
- Acronym
- PRESEL
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- 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 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Radical Prostatectomy (RP) With or Without Salvage Radiotherapy Versus RP With Extended Pelvic Lymph Node Dissection for Localized Intermediate- and High-risk Prostate Cancer With a Briganti Nomogram≥7%: an Open-label, Single-center, Non-inferiority Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07115992
- Acronym / sponsor ID
- PRESEL / 2025-423
- Conditions
- Prostate Cancer, Prostate Adenoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 11 Aug 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.
The goal of this clinical trial is to evaluate efficacy and safety of radical prostatectomy (RP) with or without salvage radiotherapy versus RP with extended pelvic lymph node dissection (ePLND) in males who have localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%. The main questions this study aim to answer are:
- Is RP with or without salvage radiotherapy non-inferior to RP with ePLND in efficacy for patients with localized intermediate/high-risk prostate cancer with a Briganti nomogram no less than 7%?
- Will complication rates of RP with or without salvage radiotherapy be significantly lower than those of RP with ePLND?
Researchers will compare the experimental arm (robot-assisted laparoscopic radical prostatectomy with or without salvage radiotherapy) versus the control arm (robot-assisted laparoscopic radical prostatectomy with ePLND) to see if differences exist in oncological efficacy and safety outcomes.
Participants will:
- Undergo one of the following surgical interventions:
- Robot-assisted laparoscopic radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), OR
- RARP alone, followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively
- Complete scheduled monitoring activities:
- Serum PSA testing: Monthly or every 3 months within 2 years after surgery
- PSMA PET/CT scans: Annually until study completion
- Report all treatment-related complications within 24 hours of onset
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: RARP±SRTParticipants in the experimental group will receive robot-assisted laparoscopic radical prostatectomy (RARP), followed by salvage radiotherapy only if biochemical recurrence occurs postoperatively. |
| Control group | Active comparator | Procedure: RARP+ePLNDParticipants in the control group will receive RARP with extended pelvic lymph node dissection, per guideline recommendations. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provided signed and dated informed consent form.
- Be male aged 18-80 years at consent.
- Commit to protocol compliance and complete all study procedures.
- Medically fit to tolerate interventions, including PSMA PET imaging, RARP, pelvic radiotherapy.
- Diagnosis of localized intermediate/high-risk prostate cancer (miN0M0):
Key exclusion criteria (9 listed)
- Prior treatments for prostate cancer, including radiotherapy, chemotherapy or endocrine therapy.
- Non-acinar adenocarcinoma histology on biopsy.
- Preoperative evidence of metastasis: nodal(N1), locally advanced(T3-4), or distant(M1) disease on imaging.
- History of pelvic lymphadenectomy or radiotherapy.
- Other malignancies within 5 years.
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 |
|---|---|---|
| RARP±SRTParticipants will undergo robot-assisted radical prostatectomy (RARP). Upon biochemical recurrence, they will receive salvage radiotherapy: 52.5-62.5 Gy in 20-25 fractions/2.5-3.0 Gy per fraction, per 2025 AUA/ASTRO/SUO guidelines. | Procedure or surgery | Experimental group |
| RARP+ePLNDParticipants will undergo robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND), encompassing bilateral removal of obturator, external iliac, internal iliac, and common iliac lymph nodes. The dissection field extends laterally to the genitofemoral nerve, medially to the bladder wall, proximally to the ureter crossing the common iliac vessels, and distally to the deep circumflex iliac vein and femoral canal. | Procedure or surgery | Control group |
Primary outcome
2-year Biochemical-recurrence Free Survival rate (2-year BFS)
Time frame: 2 years from randomization
The 2-year biochemical recurrence-free survival rate (2-year BFS) will be recorded from randomization. Biochemical recurrence (BCR) is defined as serum PSA≥0.2ng/mL confirmed by at least one repeat test >6 weeks postoperatively. Time to first BCR event is measured: 1. For control group: After RARP completion. 2. For experimental group: After salvage radiotherapy completion.
4 secondary outcomes
PSA doubling time, PSADT
Time frame: baseline and 2 years
Radiographic progression-free survival, rPFS
Time frame: 2 years from randomization
Time to First biochemical recurrence (BCR) event in the experimental group
Time frame: 2 years from randomization
Overall survival, OS
Time frame: 2 years from randomization
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 26 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RARP±SRT and RARP+ePLND in people with Prostate Cancer and Prostate Adenoma, run by Ruijin Hospital at 1 site 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 8 inclusion and 9 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 26 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 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Biochemical-recurrence Free Survival rate (2-year BFS) (time frame: 2 years from randomization). 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 26 Aug 2025.