Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Radiation: Stereotactic body RT with MR-guided boost

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 0V9
      • CancerCare Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life as per EPIC	Expanded Prostate Cancer Index Composite (EPIC) bowel domain	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life as per EPIC and SF-12	Expanded Prostate Cancer Index Composite (EPIC) questionnaire (other domains) and Medical Outcomes Study Short-Form 12 (SF-12) v2	Up to 5 years
GU and GI Toxicity	RTOG and CTCAE v4.0 genitourinary and gastrointestinal toxicities	Up to 5 years
Biochemical failure	Phoenix defined (nadir PSA + 2 ng/mL) biochemical failure	5 years
Pathologic response	Pathologic presence of malignancy on biopsy	3 years

Collaborators and Investigators

• Sponsor: CancerCare Manitoba
• Investigators: Principal Investigator: Aldrich Ong, MD, CancerCare Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): November 25, 2021
• Study Completion (Actual): November 25, 2021

Study Registration Dates

• First Submitted: October 25, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (Estimate): November 6, 2013

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 4, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Radiotherapy; Prostatic neoplasms; Dose fractionation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MD-13-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No