Post-prostatectomy Radiation Therapy–Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
Conditions
Prostate CancerSummary
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).
Detailed 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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- William Jackson, MD
Principal Investigator
- William Jackson, M.D.
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
Outcome Measures
Primary Outcome Measures
Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
Secondary Outcome Measures
Patient reported GU quality of life (QOL) up to 60 months
Patient reported GI quality of life (QOL) up to 60 months
Treatment related toxicity - acute
Treatment related toxicity - late
Time to progression
Rate of biochemical failure
Local failure, Regional failure, Distant metastases
Prostate cancer specific survival
Overall survival
Timeline
Last Updated
January 17, 2024Start Date
September 9, 2021Today
February 5, 2025Completion Date ( Estimated )
November 1, 2029
Sponsors of this trial
Lead Sponsor
University of Michigan Rogel Cancer Center