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| ID | Type | Description | Link |
|---|---|---|---|
| HUM00200905 | Other Identifier | University of Michigan |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderately Hypo-fractionated Radiation Therapy | Active Comparator | 20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks. |
|
| Ultra-Hypofractionated Radiation Therapy | Experimental | 5 fractions of ultra-hypofractionated radiation therapy with at least one day between each treatment over the course of no more than 3-4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra-hypofractionated radiation therapy | Radiation | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change 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. | 2-years post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cancer AnswerLine | Contact | 1-800-865-1125 | CancerAnswerLine@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| William Jackson, M.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Rogel Cancer Center | Recruiting | Ann Arbor | Michigan | 98107 | United States |
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|
| Moderately Hypo-fractionated Radiation Therapy | Radiation | 55 Gy in 20 fractions to prostate bed, daily, M-F, 4 weeks (42 Gy in 20 fractions to pelvic lymph nodes if included) |
|
| 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. | 60 months post-treatment |
| Treatment related toxicity - acute | Treatment related toxicity (adverse events) assessed with CTCAE version 5.0 | ≤ 90 days after treatment completion |
| Treatment related toxicity - late | Treatment related toxicity (adverse events) assessed with CTCAE version 5.0 | >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) | 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 | 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.
| 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. | 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. | up to 5 years |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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