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

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

Trial Details

NCT ID

NCT07313241

Phase

PHASE2

Sponsor

University of Texas Southwestern Medical Center

Status

RECRUITING

Cancer Type

Prostate Cancer

Interventions

Prostate Fossa Radiotherapy
Pelvic nodal Radiotherapy
Androgen Deprivation Therapy (ADT)

Locations (sample)

Dallas, Texas, United States|32.78306,-96.80667

Key Eligibility Criteria

Men aged ≥18 years with histologically confirmed prostate adenocarcinoma treated with prostatectomy in the localized setting within 10 years, with …
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 al…

For full eligibility, visit ClinicalTrials.gov.

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