Mode
Text Size
Log in / Sign up
N/A Completed N=15 Diagnostic

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search