NCT01976962

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 6, 2013

Completed
4.2 years until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

October 25, 2013

Last Update Submit

March 4, 2022

Conditions

Prostatic Neoplasms

Keywords

Prostatic neoplasmsRadiotherapyDose fractionationMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Quality of Life as per EPIC

    Expanded Prostate Cancer Index Composite (EPIC) bowel domain

    6 months

Secondary Outcomes (4)

  • Quality of Life as per EPIC and SF-12

    Up to 5 years

  • GU and GI Toxicity

    Up to 5 years

  • Biochemical failure

    5 years

  • Pathologic response

    3 years

Study Arms (1)

Prostate stereotactic body RT with MR-guided boost

EXPERIMENTAL

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

Interventions

Stereotactic body RT with MR-guided boostRADIATION

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.

Prostate stereotactic body RT with MR-guided boost

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Aldrich Ong, MD

    CancerCare Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2013

First Posted

November 6, 2013

Study Start

January 10, 2018

Primary Completion

November 25, 2021

Study Completion

November 25, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Locations

CA(1)