Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares two radiation treatment schedules for men with prostate cancer after surgery to remove the prostate. One schedule uses fewer, larger doses, called SBRT, and the other is a current standard treatment. The study compares how patients rate their quality of life 2 years after treatment.
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Men age 18 or older with prostate cancer confirmed by a tissue test, who have had their prostate removed and have a PSA blood test level of at least 0.1 ng/mL.
- At least 6 months must pass between prostate surgery and the planned start of radiation.
- Have a score of at least 70 on the KPS scale, meaning you can care for yourself but may not be able to do usual activities or work.
- If scans show unclear signs of cancer in pelvic lymph nodes, the nodes must measure 1.5 cm or less across their shorter side. Unclear signs of cancer outside the pelvis on standard scans need a tissue test showing no cancer.
- Be able to complete the EPIC-26 survey about quality of life.
- Tissue from your prostate surgery must be available for review by Michigan Medicine Pathology.
- Be able to understand the study and be willing to sign a consent form.
Who can't join
- Have had radiation treatment to the pelvis, the lower belly area.
- Have a history of moderate or severe Crohn’s disease or ulcerative colitis, or currently have active disease. These conditions cause swelling in the bowel.
- Have had narrowing of the bladder opening or the tube that carries urine out of the body.
- Have cancer that has spread to distant parts of the body or to lymph nodes beyond the common iliac blood vessels in the pelvis.
- Started testosterone-lowering treatment called an LHRH/GnRH agonist or antagonist more than 6 months before joining, or received any other testosterone-lowering or testosterone-blocking treatment.
- Have had another cancer that grew into nearby tissue within the past 3 years, except for squamous or basal cell skin cancer that was properly treated.
- Have any condition that the study doctor believes would keep you from taking part.
Simplified for readability. The official criteria below are what the study team uses.
Official 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
Study sites (1)
MI
- University of Michigan Rogel Cancer Center · Ann Arbor, MI 98107William Jackson, MD · Principal investigatorMore trials in Ann Arbor