New trial aims to halt prostate cancer spread with targeted radiation
NCT ID NCT07477626
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 3 trial is testing whether adding pelvic radiotherapy to standard hormone therapy can delay cancer progression in men whose prostate cancer has spread to nearby lymph nodes after prostate removal surgery. About 372 participants will be randomly assigned to receive either hormone therapy alone or hormone therapy plus radiation. The study will track cancer recurrence, survival, and side effects over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Androgen deprivation therapy (hormone therapy) and pelvic radiotherapy
- What this could lead to
- If successful, this could establish a new standard of care that delays cancer progression and improves survival for men with node-positive prostate cancer after surgery.
- What could go wrong
- This is a Phase 3 trial, but results are not yet available. Adding radiotherapy may increase side effects without clear benefit, and the study only includes specific patient types, so findings may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 372 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2038
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 nodes). * 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. Exclusion Criteria: * 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 efficacy 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital of Guangdong Medical University
NOT_YET_RECRUITINGZhanjiang, Guangdong, China
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Beijing Hospital
RECRUITINGBeijing, China
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Cancer Hospital, Chinese Academy of Medical Sciences
NOT_YET_RECRUITINGBeijing, China
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Dongguan People's Hospital
NOT_YET_RECRUITINGDongguan, Guangdong, China
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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, China
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Peking University First Hospital
RECRUITINGBeijing, China
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Peking University Third Hospital
NOT_YET_RECRUITINGBeijing, China
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Sun Yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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The First Affiliated Hospital of Guangzhou Medical University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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The First Affiliated Hospital of Naval Medical University
NOT_YET_RECRUITINGShanghai, China
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The First Affiliated Hospital, Sun Yat-sen University
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
NOT_YET_RECRUITINGHangzhou, Zhejiang, China
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West China Hospital, Sichuan University
RECRUITINGChengdu, Sichuan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a simple blood test outsmart prostate cancer?
- Can a new tracer spot prostate cancer return better than the standard scan?
- New drug could offer safer option after prostate cancer surgery
- Which gas pump causes less pain during robotic prostate surgery? a Head-to-Head trial
- Exercise may counteract side effects of prostate cancer hormone therapy