NCT01982786

Brief Summary

This research is being done because investigators involved in this study would like to compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy boost to see which treatment is better and what the side effects of treatment are.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

9 active sites

Status
completed

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

November 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

April 22, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2016

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2018

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 22, 2020

Completed
Last Updated

April 13, 2026

Status Verified

March 1, 2017

Enrollment Period

2.2 years

First QC Date

November 6, 2013

Results QC Date

March 30, 2017

Last Update Submit

March 24, 2026

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Ability to Accrue Patients

    The ability to accrue 60 patients over an 18 month period to a study that randomizes men with intermediate-risk prostate cancer to curative intent treatment with image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost within a Canadian multicentre setting.

    21 months

Secondary Outcomes (3)

  • Number of Participants Reported Adverse Events

    21 months

  • Treatment Compliance

    21 months

  • Radiotherapy Quality Assurance -Timing

    5 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

IGRT\* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions

Radiation: Image guided external beam radiotherapy with or without brachytherapy boost

Arm 2

ACTIVE COMPARATOR

IGRT 37.5 Gy in 15 fractions \+ HDR brachytherapy boost 15 Gy

Radiation: Image guided external beam radiotherapy with or without brachytherapy boostRadiation: Brachytherapy

Interventions

Image guided external beam radiotherapy with or without brachytherapy boostRADIATION

image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost

Arm 1Arm 2
BrachytherapyRADIATION

Brachytherapy boost

Arm 2

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed prostate adenocarcinoma. The date of the last biopsy that verifies that the eligibility criterions have been met must be within 9 months prior to randomization. There must be no prior treatment.
  • Intermediate-risk cancer patients based on the NCCN Guidelines (www.nccn.org):
  • TNM classification:
  • T2b-T2c and Gleason Score \< 8/10 and PSA \< 20 ng/ml; or
  • T1c-T2a and Gleason Score 7/10 and PSA \< 20 ng/ml; or
  • T1c-T2a and Gleason Score ≤ 6/10 and 10 ≤ PSA \< 20 ng/ml
  • For patients who have been on alpha reductase inhibitors within the last 6 months, use the following guidelines:
  • T2b-T2c and Gleason Score \< 8/10 and PSA ≤ 10 ng/ml; or
  • T1c-T2a and Gleason Score 7/10 and PSA ≤ 10 ng/ml; or
  • T1c-T2a and Gleason Score ≤ 6/10 and 5 ≤ PSA ≤ 10 ng/ml
  • No alpha reductase inhibitors (i.e. avodart, proscar) use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization.
  • Prostate volume ≤ 75 cc.
  • American Urological Association (AUA) Symptom Index score \< 20.
  • Judged to be medically fit for IGRT and HDR brachytherapy boost by a radiation oncologist.
  • ECOG Performance Status of 0 or 1.
  • +5 more criteria

You may not qualify if:

  • History of transurethral resection of the prostate (TURP).
  • Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
  • Prior or current bleeding diathesis.
  • Prior pelvic or prostate radiotherapy.
  • Previous history of (or planned) androgen deprivation therapy.
  • Evidence of metastatic disease.
  • Any serious active disease or co-morbid medical condition, laboratory abnormality, psychiatric illness, active or uncontrolled infections, or serious illnesses or medical conditions that would prevent the patient from participating or to be managed according to the protocol (according to investigator's decision).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

Lakeridge Health Oshawa

Oshawa, Ontario, L1G 2B9, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Windsor Regional Cancer Centre

Windsor, Ontario, N8W 2X3, Canada

Location

CHUM - Hopital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

McGill University - Dept. Oncology

Montreal, Quebec, H2W 1S6, Canada

Location

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Related Publications (1)

  • Vigneault E, Morton G, Parulekar WR, Niazi TM, Springer CW, Barkati M, Chung P, Koll W, Kamran A, Monreal M, Ding K, Loblaw A. Randomised Phase II Feasibility Trial of Image-guided External Beam Radiotherapy With or Without High Dose Rate Brachytherapy Boost in Men with Intermediate-risk Prostate Cancer (CCTG PR15/ NCT01982786). Clin Oncol (R Coll Radiol). 2018 Sep;30(9):527-533. doi: 10.1016/j.clon.2018.05.007. Epub 2018 Jun 11.

    PMID: 29903505RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeutics

Limitations and Caveats

Limited follow up time, delayed side effect might not be captured.

Results Point of Contact

Title
Dr. Keyue Ding
Organization
Canadian cancer trials group
kding@ctg.queensu.ca
1-613-533-6000

Study Officials

  • Eric Vigneault

    CHUQ - Hotel Dieu de Quebec, Quebec QC

    STUDY CHAIR

  • Douglas Loblaw

    Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto On

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

April 22, 2014

Primary Completion

July 5, 2016

Study Completion

October 19, 2018

Last Updated

April 13, 2026

Results First Posted

October 22, 2020

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(9)