N/A
Completed N=15
Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning
Prostate Cancer · Adenocarcinoma of the Prostate Stage I · Adenocarcinoma of the Prostate Stage II · Adenocarcinoma of the Prostate Stage III
Source: ClinicalTrials.gov NCT02470910 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Comparison of Rectal Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy. — 4.9; 9.3 cubic centimeters
Summary
This research study is evaluating whether a standard prostate MRI examination can improve radiation therapy planning for prostate cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Rectal Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy. |
4.9; 9.3 | — |
| SECONDARY Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy. |
9.6; 12.7 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02470910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.