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

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Prostate Cancer

Treatments: Radiation: SIBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT03664193

1802019010

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Single Arm

Other group

Description:

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.

Treatment:

Radiation: SIBRT