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

University of Michigan Rogel Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Radiation: Ultra-hypofractionated radiation therapy; Radiation: Moderately Hypo-fractionated Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05038332

UMCC 2021.046

HUM00200905 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 136 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Moderately Hypo-fractionated Radiation Therapy

Active Comparator group

Description:

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

Treatment:

Radiation: Moderately Hypo-fractionated Radiation Therapy

Ultra-Hypofractionated Radiation Therapy

Experimental group

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

Treatment:

Radiation: Ultra-hypofractionated radiation therapy