Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer

Randomized 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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Radiation: Image guided external beam radiotherapy with or without brachytherapy boost; Radiation: Brachytherapy

Detailed Description

Before a big study is done, a smaller study (called a "feasibility study") is required to make sure that patients and physicians are willing to participate in a study comparing the two kinds of treatments, and to verify how the radiation therapy is given in different centres across Canada.

The standard or usual treatment for this disease includes treatment with IGRT or IGRT plus HDR brachytherapy boost.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Dr. H. Bliss Murphy Cancer Centre
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Royal Victoria Regional Health Centre
    • Oshawa, Ontario, Canada, L1G 2B9
      • Lakeridge Health Oshawa
    • Toronto, Ontario, Canada, M4N 3M5
      • Odette Cancer Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Univ. Health Network-Princess Margaret Hospital
    • Windsor, Ontario, Canada, N8W 2X3
      • Windsor Regional Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H2L 4M1
      • CHUM - Hopital Notre-Dame
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University - Dept. Oncology
    • Quebec City, Quebec, Canada, G1R 2J6
      • CHUQ-Pavillon Hotel-Dieu de Quebec

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.
• ≥ 18 years of age.
• Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate.
• Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
• Protocol treatment is to begin within 4 weeks of patient randomization. HDR brachytherapy boost treatment is to begin within 3 weeks before or after IGRT for those randomized to Arm 2.
• Participants must be willing to take precautions to prevent pregnancy while on treatment. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention). However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he is responsible for beginning contraceptive measures.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions	Radiation: Image guided external beam radiotherapy with or without brachytherapy boost; image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
Active Comparator: Arm 2; IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy	Radiation: Image guided external beam radiotherapy with or without brachytherapy boost; image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost; Radiation: Brachytherapy; Brachytherapy boost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reported Adverse Events	Acute genitourinary (GU) and gastrointestinal (GI) adverse events.	21 months
Treatment Compliance	Treatment compliance will be monitored on an ongoing basis by Central Office and the designated radiotherapy quality assurance reviewer and will be described for both arms.	21 months
Radiotherapy Quality Assurance -Timing	The time from the the time from IGRT Real Time Review Signed to IGRT Real Time Review Uploaded.	5 months

Collaborators and Investigators

• Sponsor: Canadian Cancer Trials Group
• Investigators: Study Chair: Eric Vigneault, CHUQ - Hotel Dieu de Quebec, Quebec QC; Study Chair: Douglas Loblaw, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2014
• Primary Completion (Actual): July 5, 2016
• Study Completion (Actual): October 19, 2018

Study Registration Dates

• First Submitted: November 6, 2013
• First Submitted That Met QC Criteria: November 12, 2013
• First Posted (Estimated): November 13, 2013

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PR15