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.
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 initiation, biochemical response will be defined as PSA \<0.05 ng/mL or a 0.2 ng/mL decrease from pre-treatment PSA. Responders will undergo observation. Non responders will receive sequential pelvic nodal stereotactic radiotherapy in 5 fractions and a 4 month course of ADT. Primary objective is to determine whether PSAA response adapted escalation achieves non inferior 2 year freedom from progression compared with historical control data. Secondary outcomes include patient reported hormonal, urinary, and bowel symptoms (EPIC-26), as well as physician graded gastrointestinal and genitourinary toxicities. Exploratory objectives include evaluating locoregional and distant failure. This approach may reduce unnecessary toxicity for responders whole allowing early selective intensification for non responders, shortening total treatment duration for all patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
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.
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.
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.
UT Southwestern Medical Center-Dallas
Dallas, Texas, United States
RECRUITINGFreedom from failure
first occurrence of rise of PSA of 2 ng/dL above post-salvage RT nadir, clinical progression (local/regional/distant) or death due to any cause.
Time frame: 2 years from end of radiotherapy
EPIC-26 hormonal summary domain score
Patient reported hormonal symptom severity measure by the EPIC-26 questionnaire
Time frame: Baseline and regular intervals during 2 year follow up
EPIC-26 Genitourinary (GU) summary domain score
Patient reported genitourinary symptom severity measure by EPIC-26
Time frame: Baseline and regular intervals during 2 year follow up
EPIC-26 Gastrointestinal (GI) summary domain score
Patient reported gastrointestinal severity measured by EPIC-26
Time frame: Baseline and regular intervals during 2 year follow up
CTCAE v5.0 toxicity GU and GI
GI and GU adverse events will be assessed and graded according to the National Cancer Institute Common Technology Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: Baseline and regular intervals during 2 year follow up
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