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New treatment option for Prostate Cancer (Post Prostatectomy)
Official title Radiotherapy After Prostatectomy for Node Positive Prostate Cancer
ClinicalTrials.gov ID: NCT07477626
What this study is testing
What is Androgen Deprivation Therapy (ADT)?
Androgen Deprivation Therapy (ADT) is an investigational medicine, being studied as a potential treatment for prostate cancer (post prostatectomy).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate whether the addition of pelvic radiotherapy to androgen deprivation therapy (ADT) can delay disease progression and improve survival outcomes in patients with pathologically confirmed regional lymph node-positive (pN1) prostate cancer after radical prostatectomy. The main questions it aims to answer are: Does ADT combined with pelvic radiotherapy improve biochemical recurrence-free survival (bRFS) compared with ADT alone in pN1 patients?
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Age ≥ 18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Radical prostatectomy with pelvic lymph node dissection and pathologically confirmed positive pelvic lymph nodes (AJCC 8th edition: external iliac...
- ECOG performance status 0-2.
- Started postoperative GnRH agonist or antagonist therapy for less than 1 year if receiving postoperative androgen deprivation therapy\ .
You likely can't join if
- Measurable pelvic recurrence on postoperative MRI or CT (RECIST 1.1, including prostate bed and lymph nodes).
- Radiographically confirmed distant metastasis (M1a, M1b, or M1c).
- Neoadjuvant hormonal therapy \> 3 months before prostatectomy.
- Malignancy within 5 years that may interfere with study safety or how well it works assessments.
- Castration-resistant prostate cancer (CRPC) prior to enrollment per 2025 EAU criteria
- Prior radiotherapy overlapping irradiation fields that may compromise normal tissue.
See the full eligibility criteria
- Age ≥ 18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Radical prostatectomy with pelvic lymph node dissection and pathologically confirmed positive pelvic lymph nodes (AJCC 8th edition: external iliac, internal iliac, obturator, presacral, periprostatic, and/or perirectal...
- ECOG performance status 0-2.
- Started postoperative GnRH agonist or antagonist therapy for less than 1 year if receiving postoperative androgen deprivation therapy\ .
- Adequate major organ function, defined as: Hemoglobin ≥ 90 g/L Platelet count ≥ 75 × 10⁹/L Total bilirubin ≤ 3 × ULN AST or ALT ≤ 5 × ULN
- Use of effective contraception during the study and for 3 months after.
- Written informed consent provided, with willingness and ability to comply with study visits, treatments, and procedures.
- Prior postoperative ARAT use ≤ 3 months is eligible after treatment discontinuation.
- Measurable pelvic recurrence on postoperative MRI or CT (RECIST 1.1, including prostate bed and lymph nodes).
- Radiographically confirmed distant metastasis (M1a, M1b, or M1c).
- Neoadjuvant hormonal therapy \> 3 months before prostatectomy.
- Malignancy within 5 years that may interfere with study safety or how well it works assessments.
- Castration-resistant prostate cancer (CRPC) prior to enrollment per 2025 EAU criteria
- Prior radiotherapy overlapping irradiation fields that may compromise normal tissue.
- Serious comorbidities affecting study treatment.
- Psychiatric disorders preventing understanding or compliance.
- Any condition that, in the investigator's judgment, makes participation unsuitable.
The study team makes the final eligibility decision.
Where it's taking place
- Dongguan, Guangdong, China
- Guangzhou, Guangdong, China
- Zhanjiang, Guangdong, China
- Zhengzhou, Henan, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
- Beijing, China
- 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dongguan, Guangdong, China; Guangzhou, Guangdong, China; Zhanjiang, Guangdong, China; Zhengzhou, Henan, China; Chengdu, Sichuan, China; Hangzhou, Zhejiang, China and 2 more location(s). 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.