The primary purpose of this study is to compare the quality of life (QOL) reported by prostate cancer patients 2 years after treatment with ultra-hypofractionated post-prostatectomy radiation therapy (also known as stereotactic body radiation therapy \[SBRT\]) versus the self-reported QOL of those treated with moderately hypo-fractionated post-prostatectomy radiation (a current standard of care option).
Conventional or moderately hypo-fractionated radiation therapy are the current standard of care treatment options for men receiving post-prostatectomy radiation therapy. These treatment regimens typically span 4-8 weeks, representing a high burden of therapy, which may result in decreased utilization of salvage radiotherapy, the only potentially curable treatment for men with relapsed disease following prostatectomy. Ultra-hypofractionated radiation therapy (also known as stereotactic body radiation therapy \[SBRT\]) would decrease the total number of treatments to 5, delivered over 2 weeks, which would greatly reduce treatment burden.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
136
34 Gy in 5 fractions to prostate bed, every other day, M-F, \~2 weeks (25 Gy in 5 fractions to pelvic lymph nodes if included)
55 Gy in 20 fractions to prostate bed, daily, M-F, 4 weeks (42 Gy in 20 fractions to pelvic lymph nodes if included)
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
RECRUITINGChange in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
GI and GU QOL assessed with the EPIC-26 questionnaire, bowel and urinary domains. Change scores will be calculated as baseline score subtracted from 2-year score. All patients with EPIC bowel and urinary domain scores will be included in the primary endpoint analysis. The EPIC scoring manual will be followed which requires ≥ 80% of items in a domain to be completed in order to obtain a score for that domain. High bowel score \>96, low bowel score \<= 96, high urinary score \> 84, low urinary score \<=84.
Time frame: 2-years post-treatment
Patient reported GU quality of life (QOL) up to 60 months
GU QOL assessed with the EPIC-26 questionnaire, urinary domain; at the end of radiation, 3, 6, 12, and 60 months post-treatment. The EPIC scoring manual will be followed which requires ≥ 80% of items in a domain to be completed in order to obtain a score for that domain. High urinary score \> 84, low urinary score \<=84. A longitudinal analysis incorporating all follow-up time points, will be conducted separately for each domain score.
Time frame: 60 months post-treatment
Patient reported GI quality of life (QOL) up to 60 months
GI QOL assessed with the EPIC-26 questionnaire, bowel domain; at the end of radiation, 3, 6, 12, and 60 months post-treatment. The EPIC scoring manual will be followed which requires ≥ 80% of items in a domain to be completed in order to obtain a score for that domain. High bowel score \>96, low bowel score \<= 96. A longitudinal analysis incorporating all follow-up time points, will be conducted separately for each domain score.
Time frame: 60 months post-treatment
Treatment related toxicity - acute
Treatment related toxicity (adverse events) assessed with CTCAE version 5.0
Time frame: ≤ 90 days after treatment completion
Treatment related toxicity - late
Treatment related toxicity (adverse events) assessed with CTCAE version 5.0
Time frame: >90 days after treatment completion, up to 5 years
Time to progression
Time to progression (where progression is defined as the first occurrence of biochemical failure, local failure, regional failure, distant metastasis, start of salvage therapy, or death from prostate cancer)
Time frame: up to 5 years
Rate of biochemical failure
Biochemical failure will be assessed using two definitions. Definition one is a PSA ≥ 0.4 ng/mL followed by a second higher value. Definition two is the post-radiation PSA nadir + 2ng/mL
Time frame: up to 5 years
Local failure, Regional failure, Distant metastases
Descriptive statistics will be used to describe the number of local, regional and distant metastases. * Local failure is defined as development of a new biopsy-proven mass or prostate specific PET avid mass in the prostate bed after completion of protocol treatment * Regional failure is defined as radiographic evidence of pelvic lymphadenopathy (lymph node size ≥ 1.5 cm in short axis) or PET avid lymph nodes within the pelvis following protocol treatment * Distant metastases is defined as any clinical or radiographic evidence of lymph node, bone, or visceral involvement of prostate cancer
Time frame: up to 5 years
Prostate cancer specific survival
Prostate cancer specific survival defined as the duration of time from the start of treatment to death attributable to prostate cancer. Patients who have not died or die of non-prostate cancer related causes will be censored at the date of last known follow-up or date of death, respectively.
Time frame: up to 5 years
Overall survival
Overall survival defined as the duration of time from the start of treatment to death from any cause. Patients who have not died will be censored at the date of last known follow-up.
Time frame: up to 5 years
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