RECRUITING

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

Conditions

Prostate Cancer Stereotactic Body Radiation Therapy (SBRT)Ultra-hypofractionated Radiation Therapy Post-prostatectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Phase II Randomized Trial of Moderate Versus Ultra-hypofractionated Post-prostatectomy Radiation Therapy

Quick Facts

Study Start:2021-11-12

Study Completion:2029-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05038332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Study Contact

Cancer AnswerLine

CONTACT

1-800-865-1125

CancerAnswerLine@med.umich.edu

Principal Investigator

William Jackson, M.D.

PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Study Locations (Sites)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 98107

United States

Collaborators and Investigators

Sponsor: University of Michigan Rogel Cancer Center

William Jackson, M.D., PRINCIPAL_INVESTIGATOR, University of Michigan Rogel Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-12

Study Completion Date2029-11

Study Record Updates

Study Start Date2021-11-12

Study Completion Date2029-11

Terms related to this study

Keywords Provided by Researchers

Stereotactic Body Radiation Therapy (SBRT)
Ultra-hypofractionated Radiation Therapy
Post-prostatectomy

Additional Relevant MeSH Terms

Prostate Cancer