Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
Sponsor: University of Michigan Rogel Cancer Center
ClinicalTrials ID:NCT05038332
This study evaluates quality of life in prostate cancer patients post-prostatectomy, comparing ultra-hypofractionated radiation (5 treatments over 2 weeks) to moderately hypo-fractionated radiation (20 treatments over 4 weeks). Eligible participants are men aged ≥18 with specific clinical criteria. Interventions involve targeted radiation to the prostate bed and possibly pelvic lymph nodes.
Patient Parameters
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Program Overview
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).
Description
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.
Eligibility Criteria
Inclusion Criteria
- Men age ≥ 18 with histologically confirmed prostate cancer after radical prostatectomy with a PSA ≥ 0.1 ng/mL
- Interval between prostatectomy and planned radiation therapy start date ≥ 6 months
- KPS ≥ 70
- Patients with equivocal pelvic lymph nodes on imaging are eligible if the nodes are ≤ 1.5 cm in the short axis (equivocal evidence of metastatic disease outside of the pelvis on standard imaging requires documented negative biopsy)
- Ability to complete the EPIC-26 quality of life questionnaire
- Ability to obtain tissue from radical prostatectomy specimen for review by Michigan Medicine Pathology
- Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria
- Prior history of pelvic radiation therapy
- History of moderate/severe or active Crohn's disease or ulcerative colitis
- History of bladder neck or urethral stricture
- Evidence of distant metastatic disease or nodal involvement beyond the common iliac vessels
- Initiation of androgen deprivation therapy with a LHRH / GnRH agonist or antagonist greater than 6 months prior to enrollment or receipt of any non-LHRH / GnRH agonist or antagonist androgen deprivation or anti-androgen therapy
- History of another invasive malignancy within the previous 3 years except for adequately treated squamous or basal cell skin cancer
- Any condition that in the opinion of the investigator would preclude participation in this study
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Michigan Rogel Cancer Center | 98107 | Ann Arbor | Michigan |
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