The goal of this clinical trial is to determine whether stereotactic body radiotherapy (SBRT) delivered in five fractions is non-inferior to standard-of-care mildly hypofractionated radiotherapy in terms of patient-reported quality of life in adults with prostate cancer who require adjuvant or salvage radiotherapy after radical prostatectomy. The trial includes patients with or without a macroscopic recurrence in the prostate bed and allows irradiation of the regional lymphatic drainage when clinically indicated.
The main questions it aims to answer are:
* Is SBRT non-inferior to standard-of-care radiotherapy regarding urinary (GU) quality of life, measured by the change in the EPIC-26 GU domain score from baseline to 24 months after radiotherapy? * Is SBRT non-inferior to standard-of-care radiotherapy regarding bowel (GI) quality of life, measured by the change in the EPIC-26 GI domain score from baseline to 24 months after radiotherapy?
Researchers will compare SBRT delivered as 6 Gy × 5 fractions to the prostate bed with standard-of-care radiotherapy delivered as 2.625 Gy × 20 fractions (total dose 52.5 Gy) to determine whether the substantially shorter SBRT treatment provides non-inferior patient-reported urinary and bowel outcomes. When clinically indicated, treatment of the lymphatic drainage and a simultaneous integrated boost to macroscopic recurrence or involved lymph nodes may also be delivered.
Participants will:
* Be randomly assigned in a 1:1 ratio to receive either five-fraction SBRT or 20-fraction standard-of-care radiotherapy. * Receive radiotherapy to the prostate bed, with additional irradiation of the regional lymphatic drainage and/or a boost to macroscopic disease or involved lymph nodes when clinically indicated. * Complete questionnaires assessing quality of life, urinary symptoms, and sexual function, including EPIC-26, IPSS, and IIEF-5. * Undergo clinical assessments, PSA measurements, assessment of treatment-related adverse events, and radiological imaging when clinically indicated. * Attend follow-up assessments at 3, 6, 12, 18, and 24 months after radiotherapy and then annually for up to 5 years.
A total of 206 participants are planned for the trial. In addition to the primary quality-of-life outcomes, researchers will assess acute and late toxicity, biochemical recurrence-free survival, progression-free survival, time to further anti-cancer therapy, prostate cancer-specific survival, and overall survival.
Confirmed prostate cancer treated with radical prostatectomy (≥ 6 months since radical prostatectomy)
Indication for adjuvant or salvage radiotherapy (e.g. persisting or rising PSA, macroscopic recurrence, R1 resection, pT3b) at the discretion of the treating physician
Androgen deprivation therapy allowed at the discretion of the treating physician
WHO performance status 0-1
Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, dementia)
Comorbidities which predispose to significant radiotherapy toxicities (e.g. inflammatory bowel disease), at the discretion of the treating physician
Prior radiotherapy to the intended treatment site
Presence of distant metastases (M1a is not an exclusion criterion)
Parallel
Stereotactic body radiotherapy (SBRT) to the prostate bed
RadiationSBRT to the prostate bed, 6 Gy per fraction in 5 fractions on consecutive working days (EQD2 64.3 Gy at α/β 1.5), completed within approximately one week. Optional simultaneous integrated boost (SIB) up to 6.8 Gy per fraction over 5 fractions to a macroscopic recurrence. If treatment of the lymphatic drainage is indicated (e.g. Roach score above 20% and/or node-positive disease), SIB of 5 Gy per fraction over 5 fractions to the lymphatic drainage, with involved nodes boosted up to 6.8 Gy per fraction over 5 fractions. Delivered as image-guided intensity-modulated radiotherapy. Administered to the experimental arm.
Standard-of-care radiotherapy (SOC) to the prostate bed
RadiationSOC radiotherapy to the prostate bed, 2.625 Gy per fraction in 20 fractions (total 52.5 Gy; EQD2 61.95 Gy) on consecutive working days, over approximately four weeks. Optional simultaneous integrated boost (SIB) up to 3 Gy per fraction over 20 fractions to a cumulative total of 60 Gy to a macroscopic recurrence. If treatment of the lymphatic drainage is indicated (e.g. Roach score above 20% and/or node-positive disease), SIB of 2.2 Gy per fraction over 20 fractions to the lymphatic drainage, with involved nodes boosted up to 3 Gy per fraction over 20 fractions. Delivered as image-guided intensity-modulated radiotherapy. Administered to the control arm.
Change in EPIC-26 urinary (GU) domain score from baseline to 24 months
Patient-reported quality of life in the urinary (genitourinary, GU) domain, measured with the validated EPIC-26 (Expanded Prostate Cancer Index Composite) questionnaire. The outcome is the change in the GU domain score from pre-treatment (baseline) to 24 months after radiotherapy, compared between the SBRT and standard-of-care arms in a non-inferiority framework.
Change in EPIC-26 bowel (GI) domain score from baseline to 24 months
Patient-reported quality of life in the bowel (gastrointestinal, GI) domain, measured with the validated EPIC-26 questionnaire. The outcome is the change in the GI domain score from pre-treatment (baseline) to 24 months after radiotherapy, compared between the SBRT and standard-of-care arms in a non-inferiority framework.
Acute adverse events and serious adverse events ((S)AEs)
Number of grade ≥ 2 (S)AEs per patient graded according to CTCAE v5.0, occurring during the first 3 months of follow-up.
Biochemical recurrence-free survival (bRFS)
Time from inclusion to biochemical recurrence, estimated using the Kaplan-Meier method and compared between arms.
Progression-free survival (PFS), including clinical and local PFS
Time from inclusion to disease progression (clinical progression-free survival and local progression-free survival), estimated using the Kaplan-Meier method.
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Robert Förster
Lead sponsor
Kantonsspital Winterthur KSW
Sponsor institution
Swiss Cancer League
Collaborator
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