An interventional study of Low dose rate brachytherapy and High dose rate brachytherapy in Prostate Carcinoma, sponsored by Canadian Cancer Trials Group. Active, not recruiting at 7 sites in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Canadian Cancer Trials Group · Not applicable, Interventional, and Treatment
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
Radiation therapy is an accepted treatment to help manage low and intermediate risk prostate cancer. Radiation therapy can be given using machines that are outside the body (called "image guided external beam radiation therapy") or by brachytherapy, which is a form of radiation therapy where the radiation source is placed directly into the prostate gland near the tumour. The standard or usual treatments for low or intermediate risk prostate cancer are low dose-rate (LDR) brachytherapy which involves placing radioactive seeds in the prostate which deliver radiation over several months, image guided external beam radiation therapy (IGRT), or IGRT plus high dose-rate (HDR) brachytherapy boost.
High Dose-Rate (HDR) brachytherapy is another type of brachytherapy which delivers a high dose of radiation to the tumour over a period of minutes. The radiation is delivered under computer control through flexible needles, which are temporarily inserted into the prostate. This form of radiotherapy targets cancer cells within the prostate gland. HDR brachytherapy is another type of radiotherapy for prostate cancer that has the potential to help target your cancer more accurately while causing fewer side effects compared with standard radiation therapy. HDR brachytherapy is an option for treatment in some hospitals now but the best dose of radiation is still unknown. This study is testing a new dose of radiation for HDR brachytherapy.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 334 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Canadian Cancer Trials Group is the lead sponsor of 91 studies on the registry; 28 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
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Patients with localized prostate cancer are eligible according to the following guidelines:
Exclusion Criteria:
Low Dose Rate (LDR) brachytherapy with I-125 to a total dose of 144 Gy
Radiation: Low dose rate brachytherapy
High Dose Rate brachytherapy: 27 Gy in 2 fractions
Radiation: High dose rate brachytherapy
I-125 to a total dose of 144 Gy
27 Gy in 2 fractions
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
Time frame: 48 months
Disease-free survival
Time frame: 7 years
Number and severity of adverse events
Acute and long term toxicity and safety including lower urinary tract symptoms
Time frame: 7 years
Quality of Life of patient and partner utilizing EPIC, PROMIS and R-DAS fatigue short form
Time frame: 7 years
Economic Analysis
Resource utilization and economic indices of treatment administration
Time frame: 7 years
Establish a comprehensive tumour bank linked to a clinical database for further studies of predictive and prognostic biomarkers in prostate cancer
Time frame: 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
Time frame: 7 years
PSA nadir - Date PSA nadir +2 ng/ml is reached
Time frame: 7 years
Local disease progression - Clinically suspicious change in DRE with biopsy confirmation of progression or Urethral obstruction or bleeding necessitating a trans-urethral resection (TURP) only if resected tissue demonstrates malignancy
Time frame: 7 years
Regional disease progression - Prostate cancer progression involving the lymph nodes below the bifurcation of the common iliac arteries.
Time frame: 7 years
Distant disease progression - Evidence of prostate cancer by radiology or cytology or histology at sites remote from the prostate
Time frame: 7 years
Plan to share: No
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This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Canadian Cancer Trials Group