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

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).

Conditions

Prostate Cancer

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States, 98107

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan Rogel Cancer Center,

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

Study Record Dates

2029-11