Actively Recruiting
Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)
Led by University of Texas Southwestern Medical Center · Updated on 2025-12-31
68
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 years or older with confirmed prostate adenocarcinoma treated with prostatectomy within 10 years and post-operative PSA of 0.05 ng/mL or higher
- Radical prostatectomy performed at least 4 months prior without lymph node involvement
- ECOG performance status of 0 to 2
- No definite regional or distant metastatic disease confirmed by pelvic imaging within 90 days before enrollment
- For PSA 0.2 ng/mL or higher, required PET scan with FDA-approved prostate cancer imaging agent
- For PSA below 0.2 ng/mL, PET or CT or MRI imaging at investigator's discretion
- Sexually active men must agree to use effective contraception during treatment and for 60 days after
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior androgen deprivation therapy over 3 months or anti-androgen therapy over 30 days without at least 30 days washout
- Ongoing testosterone replacement therapy without willingness to stop and demonstrate appropriate hormone levels
- Previous pelvic radiotherapy
- Uncontrolled illness such as active infection, unstable heart conditions, arrhythmia, or psychiatric/social issues limiting compliance
- History of bladder neck or urethral stricture requiring intervention
- Prior or concurrent cancer that may affect safety or efficacy assessments
- Active inflammatory bowel disease requiring recurring systemic or steroid/enema therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
S
Sarah Neufeld, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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