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

Clinicaltrials.gov ID: NCT05038332
db-list-check Status RECRUITING
b-loader Phase PHASE2
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 136

Conditions

Prostate Cancer

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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • William Jackson, MD

Principal Investigator

  • William Jackson, M.D.

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

Outcome Measures

Primary Outcome Measures

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

Time Frame: 2-years post-treatment

Secondary Outcome Measures

Patient reported GU quality of life (QOL) up to 60 months

Time Frame: 60 months post-treatment

Patient reported GI quality of life (QOL) up to 60 months

Time Frame: 60 months post-treatment

Treatment related toxicity - acute

Time Frame: u2264 90 days after treatment completion

Treatment related toxicity - late

Time Frame: >90 days after treatment completion, up to 5 years

Time to progression

Time Frame: up to 5 years

Rate of biochemical failure

Time Frame: up to 5 years

Local failure, Regional failure, Distant metastases

Time Frame: up to 5 years

Prostate cancer specific survival

Time Frame: up to 5 years

Overall survival

Time Frame: up to 5 years

Timeline

  • Last Updated
    January 17, 2024
  • Start Date
    September 9, 2021
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    November 1, 2029

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