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Compares treatment options for Prostate Cancer
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%
ClinicalTrials.gov ID: NCT07115992
What this study is testing
- What it's testing
- 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: 1.
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 80, men only
You may be able to join if
- 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): i. Confirmed by: systematic biopsy + PSA + PSMA PET/MRI. ii. Briganti...
You likely can't join if
- 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.
See the full eligibility criteria
- 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): i. 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.
- 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.
- Contraindications to radiotherapy or intolerance determined by radiation oncologists.
- Severe allergy to PSMA PET ligands or excipients.
- Any other conditions precluding PSMA PET examination.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.