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This research study is evaluating whether a standard prostate MRI examination can improve radiation therapy planning for prostate cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic resonance imaging | Experimental | MRI examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy. | The volume of bladder 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony D'Amico, MD, PhD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20493642 | Background | 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. | |
| 20124169 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnetic Resonance Imaging | Magnetic Resonance Imaging (MRI) examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnetic Resonance Imaging | MRI examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy Magnetic Resonance Imaging |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | cubic centimeters | within 1 year of MRI examination |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnetic Resonance Imaging | Magnetic Resonance Imaging (MRI) examination after intraprostatic fiducial markers have been placed and prior to beginning radiotherapy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony D'Amico | DFCI/BWH | 8572151489 | adamico@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2015 | Nov 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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. |
| 18354103 | 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. |
| 10571190 | 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. |
| 9989514 | 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. |
| 8751410 | 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. |
| 12648794 | 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. |
| 35154830 | Derived | 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. |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | Comparison of Bladder Volume Receiving 70 Gy or More With CT Versus MRI-planned Prostate Radiotherapy. | The volume of bladder receiving or exceeding 70 Gy will be calculated from the dose-volume histogram. Results will be compared for CT and MRI-based plans. | Posted | Median | Inter-Quartile Range | cubic centimeters | within 1 year of MRI examination |
|
|
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |