Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning

Completed · Not applicable

Conditions studied: Prostate Cancer, Adenocarcinoma of the Prostate Stage I, Adenocarcinoma of the Prostate Stage II, Adenocarcinoma of the Prostate Stage III

In brief

This research study is evaluating whether a standard prostate MRI examination can improve radiation therapy planning for prostate cancer.

Key facts

Study ID

NCT02470910

Run by

Dana-Farber Cancer Institute

People needed

15

Starts

2015-07-01

Expected to finish

2018-07-01

Last updated by the study team

2019-12-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically confirmed prostate cancer.
• PSA level and prostate biopsy must be reviewed at Brigham and Women's Hospital or the Dana Farber Cancer Institute and should support a diagnosis of stage I-III prostate adenocarcinoma.
• Candidates with PSA greater than 20, digital rectal exam consistent with disease outside the prostate (clinical T3/T4 disease), or Gleason score 8 or greater, should have a bone scan and diagnostic pelvic CT or MRI to exclude metastatic disease.
• Prostate biopsy, serum PSA measurement, and any indicated diagnostic imaging studies must be performed within 60 days of the date of registration.
• Participants should not have had prior curative local treatment for prostate cancer, including no radiotherapy or prostatectomy. A maximum 90 days of systemic androgen deprivation therapy prior to registration is allowed.
• Participation is limited to adult patients, age 18 years or older.
• ECOG performance status ≥2 (Karnofsky ≥60%)
• Life expectancy of greater than 10 years.
• Able to tolerate an MRI examination.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Participants with known or suspected metastatic (stage IV) prostate cancer.
• Participants with an implanted device, prosthesis, or any other foreign body with ferromagnetic properties that would make them ineligible to undergo MRI examination.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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