Safety of Hypofractionated Whole-Pelvis Proton Therapy with HDR

Recruiting

18-99 years

Male

Phase 2

30 participants needed

1 Location

Brief description of study

To evaluate safety of ultrahypofractionated proton therapy to the prostate and whole pelvis with HDR brachytherapy boost. The technique will be deemed safe if 10% of patients experience a CTCAE grade 3 or higher genitourinary or gastrointestinal toxicity cumulatively over the first year of treatment.
To evaluate for multiple domains of quality of life before and after radiotherapy by using validated surveys including EPIC-26 in urinary continence, urinary obstruction, bowel, and sexual domains. We will determine minimally important differences for each domain.
To determine treatment efficacy of proton radiotherapy for all enrolled patients as evidenced by biochemical control in the months following radiation. Acute toxicity: primary endpoint, defined as any genitourinary or gastrointestinal Grade 3 or higher toxicity that occurs within the first year following radiotherapy. CTCAE version 5.0 will be employed. Quality of Life measures: EPIC-CP will be evaluated at multiple times before and after radiotherapy. We hypothesize that quality of life metrics will worsen during and immediately post-radiotherapy and then gradually improve thereafter.
Clinical efficacy: We will follow PSA to determine if evidence for biochemical recurrence following radiotherapy. PSA recurrence will be defined as an increase of 2 ng/ml higher than the nadir value following completion of radiotherapy.

Detailed description of study

For participants in this study, the following will occur:

You will receive a high dose rate (HDR) brachytherapy boost to the prostate. This is delivered in one 15 Gray fraction. Gray (Gy) is the unit of measurement for radiation. This is standard treatment for your cancer.
Approximately 2-4 weeks after the HDR brachytherapy boost, you will undergo simulation, which is a standard procedure for receiving radiation therapy for your cancer.
You will receive five fractions of whole pelvis proton radiation therapy delivered every other day (a total of 25 Gy). This is a research-related procedure (standard of care for your cancer would be to receive 25 fractions).
You may receive androgen deprivation therapy (ADT). Whether you receive ADT, when you start, and how long you will receive it will be up to your doctor. This is standard treatment for your cancer.

You will be evaluated prior to the start of treatment, on the day of the HDR brachytherapy procedure, and at least once every week during delivery of radiation therapy (up to 2 weeks). This is standard for your cancer.

You will have a follow-up visit 3, 6, 9, 12, 24, 36, 48, & 60 months after completion of radiation therapy. These are standard follow-up procedures for your cancer. You will be asked to complete quality of life questionnaires prior to the start of treatment and at every follow-up visit. These questionnaires are a research-specificprocedure.

Your doctor and/or the investigators will assess you for side effects throughout the study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Prostate Cancer
Age: Between 18 Years - 99 Years
Gender: Male

Updated on 28 Oct 2024. Study ID: 855972

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