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Prostate CancerProstate healthMen's healthRadiationDrugPhase 2

What this study is

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.

What's being tested

  • Prostate Fossa Radiotherapy

    Intervention · RADIATION

    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.

  • Pelvic nodal Radiotherapy

    Intervention · RADIATION

    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.

  • Androgen Deprivation Therapy (ADT)

    Intervention · DRUG

    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.

Study details

Sponsor
University of Texas Southwestern Medical Center
Conditions
Prostate Cancer
Enrolling
68 people
Starts
2025-11-14
Est. completion
2030-11-14
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗