Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning

NCT02470910 | Completed Results DMC

• 1 other identifier: 14-585
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer; Adenocarcinoma of the Prostate Stage I; Adenocarcinoma of the Prostate Stage II; Adenocarcinoma of the Prostate Stage III

Keywords

Prostate Cancer; Stage I-III prostate adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Comparison of Rectal Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.

  The volume of rectum receiving or exceeding 70 Gy will be calculated from the dose-volume histogram. Results will be compared for CT and MRI-based plans.

  within 1 year of MRI examination

Secondary Outcomes (1)

• Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.

  within 1 year of MRI examination

Study Arms (1)

Magnetic resonance imaging

EXPERIMENTAL

MRI examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy

Device: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DEVICE

Also known as: MRI

Magnetic resonance imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

• Kuban DA, Levy LB, Cheung MR, Lee AK, Choi S, Frank S, Pollack A. Long-term failure patterns and survival in a randomized dose-escalation trial for prostate cancer. Who dies of disease? Int J Radiat Oncol Biol Phys. 2011 Apr 1;79(5):1310-7. doi: 10.1016/j.ijrobp.2010.01.006. Epub 2010 May 20.

  PMID: 20493642 BACKGROUND

• Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, Bush DA, Lunt M, Spiegel DY, Skowronski R, Jabola BR, Rossi CJ. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09. J Clin Oncol. 2010 Mar 1;28(7):1106-11. doi: 10.1200/JCO.2009.25.8475. Epub 2010 Feb 1.

  PMID: 20124169 BACKGROUND

• Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.

  PMID: 18354103 BACKGROUND

• Debois M, Oyen R, Maes F, Verswijvel G, Gatti G, Bosmans H, Feron M, Bellon E, Kutcher G, Van Poppel H, Vanuytsel L. The contribution of magnetic resonance imaging to the three-dimensional treatment planning of localized prostate cancer. Int J Radiat Oncol Biol Phys. 1999 Nov 1;45(4):857-65. doi: 10.1016/s0360-3016(99)00288-6.

  PMID: 10571190 BACKGROUND

• Rasch C, Barillot I, Remeijer P, Touw A, van Herk M, Lebesque JV. Definition of the prostate in CT and MRI: a multi-observer study. Int J Radiat Oncol Biol Phys. 1999 Jan 1;43(1):57-66. doi: 10.1016/s0360-3016(98)00351-4.

  PMID: 9989514 BACKGROUND

• Roach M 3rd, Faillace-Akazawa P, Malfatti C, Holland J, Hricak H. Prostate volumes defined by magnetic resonance imaging and computerized tomographic scans for three-dimensional conformal radiotherapy. Int J Radiat Oncol Biol Phys. 1996 Jul 15;35(5):1011-8. doi: 10.1016/0360-3016(96)00232-5.

  PMID: 8751410 BACKGROUND

• Parker CC, Damyanovich A, Haycocks T, Haider M, Bayley A, Catton CN. Magnetic resonance imaging in the radiation treatment planning of localized prostate cancer using intra-prostatic fiducial markers for computed tomography co-registration. Radiother Oncol. 2003 Feb;66(2):217-24. doi: 10.1016/s0167-8140(02)00407-3.

  PMID: 12648794 BACKGROUND

• Schmidt DR, Bhagwat M, Glazer DI, Chen MH, Moteabbed M, McMahon E, Loffredo MJ, Tempany CM, D'Amico AV. MRI-Based Radiotherapy Planning to Reduce Rectal Dose in Excess of Tolerance. Prostate Cancer. 2022 Feb 3;2022:7930744. doi: 10.1155/2022/7930744. eCollection 2022.

  PMID: 35154830 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Anthony D'Amico
• Organization: DFCI/BWH

adamico@bwh.harvard.edu

8572151489

Study Officials

• Anthony D'Amico, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2015
• First Posted: June 12, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 11, 2019
• Results First Posted: November 27, 2019

Record last verified: 2019-12

Locations

US (1)