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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 LDR | Active Comparator | Low Dose Rate (LDR) brachytherapy with I-125 to a total dose of 144 Gy |
|
| Arm 3 HDR | Active Comparator | High Dose Rate brachytherapy: 27 Gy in 2 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose rate brachytherapy | Radiation | I-125 to a total dose of 144 Gy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | 7 years | |
| Number and severity of adverse events | Acute and long term toxicity and safety including lower urinary tract symptoms | 7 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
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:
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.
Patients must be willing to take precautions to prevent pregnancy while on study.
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Morton | Sunnybrook Health Sciences, Toronto ON | Study Chair |
| Eric Vigneault | Hotel Dieu de Quebec, Montreal, QC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre Research Inc. | London | Ontario | N6A 5W9 | Canada | ||
| Ottawa Hospital Research Institute |
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| High dose rate brachytherapy |
| Radiation |
27 Gy in 2 fractions |
|
| Quality of Life of patient and partner utilizing EPIC, PROMIS and R-DAS fatigue short form | 7 years |
| Economic Analysis | Resource utilization and economic indices of treatment administration | 7 years |
| 7 years |
| PSA nadir - Date PSA nadir +2 ng/ml is reached | 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 | 7 years |
| Regional disease progression - Prostate cancer progression involving the lymph nodes below the bifurcation of the common iliac arteries. | 7 years |
| Distant disease progression - Evidence of prostate cancer by radiology or cytology or histology at sites remote from the prostate | 7 years |
| Ottawa |
| Ontario |
| K1H 8L6 |
| Canada |
| Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| CHUM-Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2X 3E4 | Canada |
| The Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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