Phase II Trial of PSA Response-based Androgen Deprivation Therapy and Nodal Coverage for Prostate Cancer Early Salvage Radiotherapy (RANGER)
University of Texas Southwestern Medical Center
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.
Description
After radical prostatectomy, many men experience biochemical recurrence despite having no visible metastatic disease. Standard salvage radiotherapy is effective but often includes universal use of androgen deprivation therapy and pelvic nodal radiotherapy, which may expose many patients to unnecessary toxicity. The study evaluates a response adapted strategy using hypo fractionated or ultra hypo fractionated prostate fossa radiotherapy delivered on the Ethos adaptive radiotherapy platform. All participants will undergo 5 fractions of prostate fossa radiotherapy. At 5 weeks from treatment init…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * 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 emis…
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.
Location
- UT Southwestern Medical Center-DallasDallas, Texas