Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])

Sponsor
University of Michigan Rogel Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05038332
Collaborator
(none)
136
Enrollment
1
Location
2
Arms
96
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or DiseaseIntervention/TreatmentPhase
  • Radiation: Ultra-hypofractionated radiation therapy
  • Radiation: Moderately Hypo-fractionated Radiation Therapy
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
136 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2026
Anticipated Study Completion Date :
Nov 1, 2029

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Moderately Hypo-fractionated Radiation Therapy

20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.

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)

Experimental: Ultra-Hypofractionated Radiation Therapy

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

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)
Other Names:
  • stereotactic body radiation therapy [SBRT]
  • Outcome Measures

    Primary Outcome Measures

    1. Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline [2-years post-treatment]

      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.

    Secondary Outcome Measures

    1. Patient reported GU quality of life (QOL) up to 60 months [60 months post-treatment]

      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.

    2. Patient reported GI quality of life (QOL) up to 60 months [60 months post-treatment]

      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.

    3. Treatment related toxicity - acute [≤ 90 days after treatment completion]

      Treatment related toxicity (adverse events) assessed with CTCAE version 5.0

    4. Treatment related toxicity - late [>90 days after treatment completion, up to 5 years]

      Treatment related toxicity (adverse events) assessed with CTCAE version 5.0

    5. Time to progression [up to 5 years]

      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)

    6. Rate of biochemical failure [up to 5 years]

      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

    7. Local failure, Regional failure, Distant metastases [up to 5 years]

      Descriptive statistics will be used to describe the number of local, regional and distant metastases. Local failure is defined as development of a new biopsy-proven mass or prostate specific PET avid mass in the prostate bed after completion of protocol treatment Regional failure is defined as radiographic evidence of pelvic lymphadenopathy (lymph node size ≥ 1.5 cm in short axis) or PET avid lymph nodes within the pelvis following protocol treatment Distant metastases is defined as any clinical or radiographic evidence of lymph node, bone, or visceral involvement of prostate cancer

    8. Prostate cancer specific survival [up to 5 years]

      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.

    9. Overall survival [up to 5 years]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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 paraffin-embedded tissue block from radical prostatectomy specimens

    • 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of Michigan Rogel Cancer CenterAnn ArborMichiganUnited States98107

    Sponsors and Collaborators

    • University of Michigan Rogel Cancer Center

    Investigators

    • Principal Investigator: William Jackson, M.D., University of Michigan Rogel Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Michigan Rogel Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05038332
    Other Study ID Numbers:
    • UMCC 2021.046
    • HUM00200905
    First Posted:
    Sep 9, 2021
    Last Update Posted:
    Oct 6, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by University of Michigan Rogel Cancer Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 6, 2021