Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) With High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Indiana University
- Enrollment
- 31
- Locations
- 2
- Primary Endpoint
- Percentage of participants with acute grade ≥ 2 GU toxicity
Study Overview
Brief Summary
The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).
Detailed Description
Progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. Irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. Brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years old at the time of informed consent
- •Capable of providing informed consent and HIPAA authorization
- •Karnofsky performance score ≥ 70
- •Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician
- •Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure
Exclusion Criteria
- •Prior pelvic irradiation treatment
- •Prior rectal surgery which precludes instrumentation with rectal ultrasound probe.
- •Evidence of nodal or distant disease on screening diagnostic work up.
- •Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure
- •International Prostate Symptom Score (IPSS) score > 16 despite medical therapy
Arms & Interventions
ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
Single arm non-randomized non-inferiority study exploring tolerability of ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.
Intervention: ePURT 5Gy x 5 fractions with single HDR boost of 15Gy (Radiation)
Outcomes
Primary Outcomes
Percentage of participants with acute grade ≥ 2 GU toxicity
Time Frame: 3 months
Physician-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by CTCAE version 5.
Secondary Outcomes
- Percentage of participants with acute grade ≥ 2 GI toxicity(3 months)
- Percentage of participants with acute grade ≥ 2 GU toxicity(3 months)
Investigators
Omar Ishaq
Assistant Professor of Clinical Urology
Indiana University