Back to resultsPost-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ultra-hypofractionated radiation therapy
Moderately Hypo-fractionated Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Stereotactic Body Radiation Therapy (SBRT), Ultra-hypofractionated Radiation Therapy, Post-prostatectomy
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
Sites / Locations
- University of Michigan Rogel Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Moderately Hypo-fractionated Radiation Therapy
Ultra-Hypofractionated Radiation Therapy
Arm Description
20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Treatment related toxicity - acute
Treatment related toxicity (adverse events) assessed with CTCAE version 5.0
Treatment related toxicity - late
Treatment related toxicity (adverse events) assessed with CTCAE version 5.0
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)
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
Local failure, Regional failure, Distant metastases
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
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.
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.
Full Information
NCT ID
NCT05038332
First Posted
August 31, 2021
Last Updated
December 20, 2022
Sponsor
University of Michigan Rogel Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05038332
Brief Title
Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
Official Title
A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2021 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Stereotactic Body Radiation Therapy (SBRT), Ultra-hypofractionated Radiation Therapy, Post-prostatectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Moderately Hypo-fractionated Radiation Therapy
Arm Type
Active Comparator
Arm Description
20 fractions of moderately hypofractionated radiation therapy over no more than 5-6 weeks.
Arm Title
Ultra-Hypofractionated Radiation Therapy
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
Ultra-hypofractionated radiation therapy
Other Intervention Name(s)
stereotactic body radiation therapy [SBRT]
Intervention Description
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)
Intervention Type
Radiation
Intervention Name(s)
Moderately Hypo-fractionated Radiation Therapy
Intervention Description
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 Measure Information:
Title
Change in patient reported GI and GU quality of life (QOL) at 2-years post-treatment from baseline
Description
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.
Time Frame
2-years post-treatment
Secondary Outcome Measure Information:
Title
Patient reported GU quality of life (QOL) up to 60 months
Description
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.
Time Frame
60 months post-treatment
Title
Patient reported GI quality of life (QOL) up to 60 months
Description
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.
Time Frame
60 months post-treatment
Title
Treatment related toxicity - acute
Description
Treatment related toxicity (adverse events) assessed with CTCAE version 5.0
Time Frame
≤ 90 days after treatment completion
Title
Treatment related toxicity - late
Description
Treatment related toxicity (adverse events) assessed with CTCAE version 5.0
Time Frame
>90 days after treatment completion, up to 5 years
Title
Time to progression
Description
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)
Time Frame
up to 5 years
Title
Rate of biochemical failure
Description
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
Time Frame
up to 5 years
Title
Local failure, Regional failure, Distant metastases
Description
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
Time Frame
up to 5 years
Title
Prostate cancer specific survival
Description
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.
Time Frame
up to 5 years
Title
Overall survival
Description
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.
Time Frame
up to 5 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cancer AnswerLine
Phone
1-800-865-1125
Email
CancerAnswerLine@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Jackson, M.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Rogel Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
98107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Jackson, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-prostatectomy Radiation Therapy--Moderate Versus Ultra-hypofractionated (Also Known as Stereotactic Body Radiation Therapy [SBRT])
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