Active — Not RecruitingNot Applicable

MRI Guided SBRT for Localized Prostate Cancer

United States54 participantsStarted 2016-05-23

Plain-language summary

This study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions. In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered. In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.

Who can participate

Age range18 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Biopsy proven prostate adenocarcinoma within 1 year of randomization * NCCN Low to High Risk localized prostate cancer * Zubrod Performance Status 0-1 within 60 days prior to registration Exclusion Criteria: * Prior or concurrent invasive malignancy (except non-melanoma skin cancer) * Regional Lymph Node (N1) involvement * Distant Metastases (M1) involvement * History of prior pelvic irradiation (external beam radiotherapy or brachytherapy) * Prior chemotherapy * Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease; AIDS) * Acute bacterial or fungal infection requiring IV antibiotics * Inability to undergo MRI * Inability to receive fiducial markers

What they're measuring

Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity

Timeframe: 18 months

Trial details

NCT IDNCT03778112

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03

Results submitted2022-11-02

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