Clincosm LogoSign in Get a demo

Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer

Sponsor
CancerCare Manitoba (Other)
Overall Status
Terminated
CT.gov ID
NCT01976962
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
46.5
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Radiation: Stereotactic body RT with MR-guided boost
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 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 :
Jan 10, 2018
Actual Primary Completion Date :
Nov 25, 2021
Actual Study Completion Date :
Nov 25, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Quality of Life as per EPIC [6 months]

    Expanded Prostate Cancer Index Composite (EPIC) bowel domain

Secondary Outcome Measures

  1. Quality of Life as per EPIC and SF-12 [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 [Up to 5 years]

    RTOG and CTCAE v4.0 genitourinary and gastrointestinal toxicities

  3. Biochemical failure [5 years]

    Phoenix defined (nadir PSA + 2 ng/mL) biochemical failure

  4. Pathologic response [3 years]

    Pathologic presence of malignancy on biopsy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CancerCare Manitoba Winnipeg Manitoba Canada R3E 0V9

Sponsors and Collaborators

  • CancerCare Manitoba

Investigators

  • Principal Investigator: Aldrich Ong, MD, CancerCare Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CancerCare Manitoba
ClinicalTrials.gov Identifier:
NCT01976962
Other Study ID Numbers:
  • MD-13-03
First Posted:
Nov 6, 2013
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2022
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
Radiotherapy
Dose fractionation
Magnetic resonance imaging
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Mar 18, 2022