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Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer

Primary Purpose

Prostatic Neoplasms

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Stereotactic body RT with MR-guided boost

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostatic neoplasms, Radiotherapy, Dose fractionation, Magnetic resonance imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

CancerCare Manitoba

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostate stereotactic body RT with MR-guided boost

Arm Description

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.

Outcomes

Primary Outcome Measures

Quality of Life as per EPIC

Expanded Prostate Cancer Index Composite (EPIC) bowel domain

Secondary Outcome Measures

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

GU and GI Toxicity

RTOG and CTCAE v4.0 genitourinary and gastrointestinal toxicities

Biochemical failure

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

Pathologic response

Pathologic presence of malignancy on biopsy

Full Information

NCT ID

NCT01976962

First Posted

October 25, 2013

Last Updated

March 4, 2022

Sponsor

CancerCare Manitoba

1. Study Identification

Unique Protocol Identification Number

NCT01976962

Brief Title

Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer

Official Title

Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Terminated

Why Stopped

Lack of adequate sample size.

Study Start Date

January 10, 2018 (Actual)

Primary Completion Date

November 25, 2021 (Actual)

Study Completion Date

November 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CancerCare Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

Keywords

Prostatic neoplasms, Radiotherapy, Dose fractionation, Magnetic resonance imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prostate stereotactic body RT with MR-guided boost

Arm Type

Experimental

Arm Description

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.

Intervention Type

Radiation

Intervention Name(s)

Stereotactic body RT with MR-guided boost

Intervention Description

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 Measure Information:

Title

Quality of Life as per EPIC

Description

Expanded Prostate Cancer Index Composite (EPIC) bowel domain

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Quality of Life as per EPIC and SF-12

Description

Expanded Prostate Cancer Index Composite (EPIC) questionnaire (other domains) and Medical Outcomes Study Short-Form 12 (SF-12) v2

Time Frame

Up to 5 years

Title

GU and GI Toxicity

Description

RTOG and CTCAE v4.0 genitourinary and gastrointestinal toxicities

Time Frame

Up to 5 years

Title

Biochemical failure

Description

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

Time Frame

5 years

Title

Pathologic response

Description

Pathologic presence of malignancy on biopsy

Time Frame

3 years

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aldrich Ong, MD

Organizational Affiliation

CancerCare Manitoba

Official's Role

Principal Investigator

Facility Information:

Facility Name

CancerCare Manitoba

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Functional MR-guided Stereotactic Body Radiation Therapy of Prostate Cancer

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