Clinical trial NCT02470910: Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning
Official title: Incorporating MR Imaging Into Prostate Radiotherapy Treatment Planning: A Pilot Study to Quantitate the Potential to Limit Radiation Dose to Normal Tissues.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed description: In this research study, the investigators want to determine if prostate radiotherapy treatment planning can be improved by using an MRI scan to help doctors more accurately target the prostate with radiation and decrease radiation dose to the rectum, which is just behind the prostate.

To do this, the investigators will create a treatment plan based on the MRI scan and compare it to the standard treatment, which currently uses a CT scan rather than an MRI. The results of this study will help inform doctors whether it is beneficial to routinely use an MRI scan for prostate radiotherapy treatment planning.

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.

Primary outcomes:
measure: Comparison of Rectal Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.
timeFrame: within 1 year of MRI examination
Secondary outcomes:
measure: Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy.
timeFrame: within 1 year of MRI examination
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Anthony D'Amico, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.