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Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01976962
Recruitment Status : Recruiting
First Posted : November 6, 2013
Last Update Posted : February 20, 2019
Information provided by (Responsible Party):
CancerCare Manitoba

Brief Summary:
To improve radiation therapy of prostate cancer, the investigators must be able to accurately identify the tumour. By using advanced functional imaging techniques available on state-of-the-art MRI scanners to clearly show the specific location of the tumour inside the prostate, the investigators can use advanced radiation therapy techniques to specifically target the tumor and control it with as few radiotherapy clinic visits as possible. This is different than current techniques which treat the whole prostate gland to the same dose, delivered over 7-8 weeks of daily radiotherapy visits. By increasing the radiation dose to the active tumor while still maintaining adequate radiation dose to the rest of the prostate, the investigators hope to better control prostate cancer and reduce complications to nearby normal tissues.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Radiation: Stereotactic body RT with MR-guided boost Not Applicable

Detailed Description:
This project combines advances in functional imaging of prostate cancer and hypofractionation through stereotactic body radiotherapy (SBRT), with an aim to improve tumour control and reduce or maintain normal tissue complications. The strategy will make use of the combined effectiveness of several functional imaging approaches to identify the dominant lesion(s) within the prostate. An SBRT treatment plan will be designed which utilizes 5 fractions to treat the entire prostate gland with an additional boost to the dominant lesion. The lower dose to the entire prostate should reduce normal tissue complications but still be effective in treating prostate cancer while the increased dose to the dominant lesion should improve tumour control. The use of only 5 fractions will reduce the number of patient visits, thus reducing overall treatment costs.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 77 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Prostate stereotactic body RT with MR-guided boost
Patients will receive a dose of 36.25 Gy in 5 fractions to the entire prostate and proximal seminal vesicles with an additional boost to the dominant lesion for a total of 40 Gy in 5 fractions.
Radiation: Stereotactic body RT with MR-guided boost
Patients will receive radiotherapy over 5 fractions delivered once per week over 29 days, with 7.25 Gy per fraction to the whole prostate and 8 Gy per fraction to the dominant intraprostatic lesion. There will be a minimum of 120 hours and maximum of 192 hours between fractions. The entire course of treatment should be completed within no less than 27 days and no longer than 30 days.

Primary Outcome Measures :
  1. Quality of Life as per EPIC [ Time Frame: 6 months ]
    Expanded Prostate Cancer Index Composite (EPIC) bowel domain

Secondary Outcome Measures :
  1. Quality of Life as per EPIC and SF-12 [ Time Frame: Up to 5 years ]
    Expanded Prostate Cancer Index Composite (EPIC) questionnaire (other domains) and Medical Outcomes Study Short-Form 12 (SF-12) v2

  2. GU and GI Toxicity [ Time Frame: Up to 5 years ]
    RTOG and CTCAE v4.0 genitourinary and gastrointestinal toxicities

  3. Biochemical failure [ Time Frame: 5 years ]
    Phoenix defined (nadir PSA + 2 ng/mL) biochemical failure

  4. Pathologic response [ Time Frame: 3 years ]
    Pathologic presence of malignancy on biopsy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed consent
  • Age >18 years
  • Histologically confirmed and centrally reviewed prostate adenocarcinoma based
  • PSA within 60 days
  • High risk prostate cancer defined as any one of: clinical stage >= T3, Gleason score >= 8, or PSA >=20 and <50 ng/mL.

Exclusion Criteria:

  • Evidence of lymph node metastasis
  • Evidence of distant metastases
  • Prior pelvic radiotherapy or brachytherapy
  • Previous radical prostatectomy, cryotherapy, or high-frequency ultrasound
  • Unable to undergo gold seed insertion
  • Immunosuppressive medications
  • Inflammatory bowel disease
  • Unable to undergo MRI
  • Previous bilateral orchiectomy
  • Previous hormonal therapy including LHRH agonists (leuprolide, goserelin), LHRH antagonists (degarelix), anti-androgens (bicalutamide, flutamide, nilutamide), surgical castration, and estrogens
  • Previous finasteride within 14 days.
  • Previous dutasteride within 180 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01976962

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Contact: Aldrich Ong, MD (204) 787-2116
Contact: Lawrence Ryner, PhD (204) 787-8537

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Canada, Manitoba
CancerCare Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Principal Investigator: Aldrich Ong, MD         
Sponsors and Collaborators
CancerCare Manitoba
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Principal Investigator: Aldrich Ong, MD CancerCare Manitoba
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Responsible Party: CancerCare Manitoba Identifier: NCT01976962    
Other Study ID Numbers: MD-13-03
First Posted: November 6, 2013    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CancerCare Manitoba:
Prostatic neoplasms
Dose fractionation
Magnetic resonance imaging
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases