Evaluating Tolerability of ePUHRT With Brachytherapy Boost
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ePURT 5Gy x 5 fractions with single HDR boost of 15Gy.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) With High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer
Overview
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.
Interventions
- Radiation ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.
Primary outcome measures
- Percentage of participants with acute grade ≥ 2 GU toxicity [Time frame: 3 months]
Secondary outcome measures (2)
- Percentage of participants with acute grade ≥ 2 GI toxicity [Time frame: 3 months]
- Percentage of participants with acute grade ≥ 2 GU toxicity [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis
Identifiers
NCT: NCT06817668 · CTO-IUSCCC-0832