RecruitingPhase 2NCT07313241

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


Sponsor

University of Texas Southwestern Medical Center

Enrollment

68 participants

Start Date

Nov 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This Phase II, single arm study evaluates a PSA-response-adapted approach to salvage radiotherapy after radical prostatectomy for prostate cancer. All participants will receive hypo-fractionated stereotactic radiotherapy to the prostate fossa. At 5 weeks, biochemical response will be assessed. responders will proceed to observation, while non responders will receive sequential pelvic nodal radiotherapy and 4 months of androgen deprivation therapy (ADT). The study aims to determine whether this response base approach achieves non inferior 2 year freedom from progression compared with historical outcomes using routine pelvic nodal radiotherapy and ADT in all patients.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II trial (called RANGER) investigates personalised radiation therapy for men with prostate cancer that has risen again after prostatectomy (surgical removal of the prostate). It uses PSA blood test levels to guide how much hormone therapy is given alongside salvage radiotherapy, and whether radiation covers nearby lymph nodes. **You may be eligible if...** - You are a man aged 18 or older - You had surgery to remove your prostate (prostatectomy) for localised prostate cancer within the past 10 years - Your PSA level is rising or persistently elevated at 0.05 ng/mL or higher after surgery - There is no confirmed evidence that the cancer has spread to lymph nodes or distant sites - Your general health is good (ECOG 0–2) **You may NOT be eligible if...** - Your cancer has confirmed spread to lymph nodes or other organs - Less than 4 months have passed since your prostatectomy - Your overall health prevents radiotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProstate Fossa Radiotherapy

Stereotactic ultra hypofractionanted radiotherapy delivered to the prostate fossa using the Ethos online adaptive platform. Total dose of 32.5 Gy administered in 5 fractions over 2-4 weeks.

RADIATIONPelvic nodal Radiotherapy

Sequential pelvic nodal radiotherapy delivered only to PSA non responders. Dose of 25 Gy given in 5 fractions over 4 weeks using the same stereotactic technique as prostate fossa RT.

DRUGAndrogen Deprivation Therapy (ADT)

GnRH agonist or antagonist (leuprolide, goserelin, degarelix) administered as per institutional standard. Therapy duration is 4 months, starting before or within 14 days of pelvic nodal RT initiation.


Locations(1)

UT Southwestern Medical Center-Dallas

Dallas, Texas, United States

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NCT07313241


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