Phase II High Dose Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

NCT02960087 | Active Not Recruiting DMC

• 1 other identifier: PR19
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy chosen for this study as well as a commonly used alternate form of brachytherapy called low dose rate (or seed) brachytherapy. Investigators would like to understand how these treatments control the prostate cancer and look at their short and long term treatment related side effects. The dose of radiation for HDR brachytherapy for this study has been changed since the study started. Other studies using the dose of radiation for HDR brachytherapy that was originally chosen for this study (Arm 2) found that this dose of radiation may be linked to a greater chance of the cancer coming back in the prostate. Therefore since March 2020, for new participants entering the study, a new HDR brachytherapy arm with a higher amount of radiation given over two doses will be tested in this study

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• Efficacy of HDR and LDR brachytherapy on prostate cancer control as defined by 48 month PSA values

  The primary endpoint of the study is prostate cancer control rate at 48 months. It is defined as the PSA \<0.4ng/ml at 48 months. One sample binomial test will be used to test the 48 months disease control rate for each arm

  48 months

Secondary Outcomes (4)

• Disease-free survival

  7 years

• Number and severity of adverse events

  7 years

• Quality of Life of patient and partner utilizing EPIC, PROMIS and R-DAS fatigue short form

  7 years

• Economic Analysis

  7 years

Other Outcomes (6)

• Establish a comprehensive tumour bank linked to a clinical database for further studies of predictive and prognostic biomarkers in prostate cancer

  7 years

• PSA Progression - PSA nadir +2 ng/ml will be used to define biochemical failure and can only be declared at 36 months or beyond due to the phenomenon of PSA bounce

  7 years

• PSA nadir - Date PSA nadir +2 ng/ml is reached

  7 years

Study Arms (2)

Arm 1 LDR

ACTIVE COMPARATOR

Low Dose Rate (LDR) brachytherapy with I-125 to a total dose of 144 Gy

Radiation: Low dose rate brachytherapy

Arm 3 HDR

ACTIVE COMPARATOR

High Dose Rate brachytherapy: 27 Gy in 2 fractions

Radiation: High dose rate brachytherapy

Interventions

Low dose rate brachytherapy RADIATION

I-125 to a total dose of 144 Gy

Arm 1 LDR

High dose rate brachytherapy RADIATION

27 Gy in 2 fractions

Arm 3 HDR

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 9 months).
• Patients with localized prostate cancer are eligible according to the following guidelines:
• TNM classification:
• Clinical stage T1-T2 and Gleason 6 and PSA \<20 ng/mL
• Clinical stage T1-T2 and Gleason 7 (3+4) and PSA \< 15 ng/mL and ≤ 50% of positive nontargeted cores in patients who undergo systematic biopsy
• Eastern Cooperative Oncology Group status 0-1.
• Bone scan and pelvic CT scan/MRI within the last 6 months at the discretion of the treating physician.
• Patient must be ≥ 18 years of age.
• Judged to be medically fit for brachytherapy.
• Prostate volume by Trans-rectal Ultrasound (TRUS) or Magnetic Resonance Imaging (MRI) ≤ 60 cc within the last 6 months.
• American Urological Association (AUA) score ≤ 20 (alpha blockers allowed) within the last 4 weeks.
• Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French.
• 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.
• In accordance with CCTG policy, protocol treatment is to begin within 12 weeks of patient randomization.

You may not qualify if:

• Prior or current bleeding diathesis.
• Previous androgen deprivation therapy (ADT).
• Alpha-reductase inhibitors (ARIs) within 90 days of randomization.
• Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior TURP, prior cryosurgery of the prostate.
• Evidence of metastatic disease (radiology investigations at the discretion of the treating physician).
• Any serious active or co-morbid medical conditions, 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).

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead

Study Sites (7)

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

The Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Gerard Morton

  Sunnybrook Health Sciences, Toronto ON

  STUDY CHAIR

• Eric Vigneault

  Hotel Dieu de Quebec, Montreal, QC

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 9, 2016
• Study Start: March 6, 2017
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): October 30, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)