Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultra-hypofractionated radiation therapy, Moderately Hypo-fractionated Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy
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).
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.
Interventions
- Radiation Ultra-hypofractionated radiation therapy
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) - Radiation Moderately Hypo-fractionated Radiation Therapy
55 Gy in 20 fractions to prostate bed, daily, M-F, 4 weeks (42 Gy in 20 fractions to pelvic lymph nodes if included)
Primary outcome measures
- Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline [Time frame: 2-years post-treatment]
Secondary outcome measures (9)
- Patient reported GU quality of life (QOL) up to 60 months [Time frame: 60 months post-treatment]
- Patient reported GI quality of life (QOL) up to 60 months [Time frame: 60 months post-treatment]
- Treatment related toxicity - acute [Time frame: ≤ 90 days after treatment completion]
- Treatment related toxicity - late [Time frame: >90 days after treatment completion, up to 5 years]
- Time to progression [Time frame: up to 5 years]
- Rate of biochemical failure [Time frame: up to 5 years]
- Local failure, Regional failure, Distant metastases [Time frame: up to 5 years]
- Prostate cancer specific survival [Time frame: up to 5 years]
- Overall survival [Time frame: up to 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan Rogel Cancer Center — Ann Arbor
Identifiers
NCT: NCT05038332 · UMCC 2021.046 · HUM00200905