MRI-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost for Prostate Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-24

Study Completion Date

2020-01-28

Brief Summary

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Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity.

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Detailed Description

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Prostate SBRT is a standard of care treatment for prostate cancer that has not spread to distant metastatic sites. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity. In this initial study, MRI guided treatment planning and delivery will be used to deliver 7 Gy to the entire prostate and seminal vesicles, with a selective boost of additional 0.5, 1.0, 1.5, or 2 Gy per fraction for a total dose of 37.5, 40, 42.5 or 45 Gy to biopsy-proven lesions, defined using MRI.

Hypothesis: MRI-guided treatment planning and delivery can selectively target high-risk prostate nodules and deliver a higher radiation dose, to achieve maximal local control without increasing treatment toxicity

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Male patients with a histologically confirmed diagnosis of non-metastatic prostate adenocarcinoma, meeting the inclusion and exclusion criteria below, and electing to undergo definitive radiation treatment with SBRT, will be eligible for participation in this study. Patients will receive 35 Gy in five fractions, also, patients will receive a simultaneous integrated boost from 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy. Gastrointestinal/genitourinary toxicities will be assessed at every visit, including quality of life questionnaires and EPIC scores will be assessed at the one month follow up visits.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.

Group Type OTHER

SIBRT

Intervention Type RADIATION

Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.

Interventions

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SIBRT

Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. Biopsy-proven diagnosis of prostate adenocarcinoma
2. NCCN defined low-, intermediate- and high-risk prostate cancer
3. Age ≥ 18
4. Patient must have prostate MRI with a PIRADS 3-5 lesion or PSMA positron emission tomography (PET) with an avid intraprostatic lesion

Exclusion Criteria

1. History of prior pelvic radiation (external beam or brachytherapy)
2. Inability to undergo MRI
3. Patients with metastatic disease (other than pelvic lymph nodes) are ineligible for this study
4. American Urological Association (AUA) score \>17 - AUA score \>17

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No