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Phase II Study of PSA-Response Adapted Radiotherapy for Prostate Cancer

This study, called RANGER, is for men with prostate cancer that has returned after surgery (radical prostatectomy). It's testing a new way to give radiation therapy and hormone therapy (Androgen Deprivation Therapy or ADT, using drugs like leuprolide, goserelin, or degarelix). All participants will receive radiation to the prostate area. If your PSA (prostate-specific antigen) level doesn't drop enough after this, you'll then receive additional radiation to the pelvic lymph nodes and 4 months of ADT. The goal is to see if this personalized approach works as well as standard treatment, but with potentially fewer side effects. The study plans to enroll 68 men and is currently unclear about its recruitment status. You can join if you are a man aged 18 or older, had prostatectomy within 10 years, and your PSA is 0.05 ng/mL or higher.

Study design
This is a Phase II study, meaning it's testing if a new treatment approach works. It's a single-arm study, so everyone receives the same treatment plan, and it aims to enroll 68 participants.
What's involved
You will receive 5 radiation treatments to the prostate area over 2-4 weeks. If your PSA doesn't respond, you'll have 5 more radiation treatments to the pelvic lymph nodes and take ADT for 4 months.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be tracked for at least 2 years after your last radiation treatment to see if the cancer stays away.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07313241

Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~68 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Prostate Fossa RadiotherapyPelvic nodal RadiotherapyAndrogen Deprivation Therapy (ADT)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Freedom from failure
Measured over 2 years from end of radiotherapy

Conditions

Prostate Cancer

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Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Aurelie Garant, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Sarah Neufeld, MS
[email protected]
214-645-8525
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Men aged ≥18 years with histologically confirmed prostate adenocarcinoma treated with prostatectomy in the localized setting within 10 years, with post-operative PSA (persistent or rising) of ≥0.05ng/mL.
Radical prostatectomy ≥4 months prior to enrollment without nodal involvement (pN0 or pNx)
Performance status ECOG 0-2
No definite evidence of regional or distant metastatic disease by at least pelvic imaging within 90 days of registration. Equivocal findings are allowed at investigator discretion. Imaging is specified as follows:
PSA\>=0.2ng/mL: positron emission tomography (PET) with FDA-approved advanced imaging agent for prostate cancer (e.g. PSMA) required.
PSA \<0.2 n/gm: PET with above noted agents OR conventional CT or MRI at investigator discretion.
All sexually active men must agree to use adequate contraception for the duration of study therapies and a period of 60 days thereafter. Should a female partner of a trial participant become pregnant or suspect she is pregnant while the subject is participating in this study, the patient should inform his treating physician immediately.
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Prior androgen deprivation therapy (ADT) \> 3 months OR anti-androgen therapy (AAT) of \> 30 days. For shorter courses of either, at least 30 day "wash out" period is required with confirmation of resolved castration of testosterone to \>50ng/mL.
Ongoing testosterone replacement therapy (TRT) with refusal to discontinue (must be stopped with demonstration of detectable PSA ≥0.05ng/mL and non-castrate testosterone \>50ng/mL after 14 days of TRT cessation)
Prior pelvic radiotherapy
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
History of bladder neck or urethral stricture requiring procedural intervention.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to actively interfere with the safety or efficacy assessments of this study in the investigator's view.
Active inflammatory bowel disease requiring recurring systemic or steroid/enema therapy

What this trial measures

  • Freedom from failure2 years from end of radiotherapy

    first occurrence of rise of PSA of 2 ng/dL above post-salvage RT nadir, clinical progression (local/regional/distant) or death due to any cause.