Prostate CarcinomaNCT02960087
Phase II High Dose Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
A study testing Low dose rate brachytherapy and High dose rate brachytherapy in people with Prostate Carcinoma, run by Canadian Cancer Trials Group at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Low dose rate brachytherapy and High dose rate brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 7 sitesCanada
- Study dates
- 6 Mar 2017to 30 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
London Health Sciences Centre Research Inc.
London, Ontario, N6A 5W9
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
The Jewish General Hospital
Montreal, Quebec, H3T 1E2
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
University Health Network
Toronto, Ontario, M5G 2M9
About this study
Official title: A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
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
Read the detailed description
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.
- Conditions
- Prostate Carcinoma
- Being tested
- Low dose rate brachytherapy, High dose rate brachytherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose rate brachytherapyRadiation
I-125 to a total dose of 144 Gy
High dose rate brachytherapyRadiation
27 Gy in 2 fractions
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 LDR | Active comparator | Low Dose Rate (LDR) brachytherapy with I-125 to a total dose of 144 Gy Receives: Radiation: Low dose rate brachytherapy |
| Arm 3 HDR | Active comparator | High Dose Rate brachytherapy: 27 Gy in 2 fractions Receives: Radiation: High dose rate brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 months
Secondary outcomes (4)
Disease-free survival
Measured: 7 years
Number and severity of adverse events
Acute and long term toxicity and safety including lower urinary tract symptoms
Measured: 7 years
Quality of Life of patient and partner utilizing EPIC, PROMIS and R-DAS fatigue short form
Measured: 7 years
Economic Analysis
Resource utilization and economic indices of treatment administration
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start6 Mar 2017
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Gerard Morton, Study chair, Sunnybrook Health Sciences, Toronto ONEric Vigneault, Study chair, Hotel Dieu de Quebec, Montreal, QC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960087
- Sponsor's protocol ID
- PR19
- Status last verified
- Apr 2026
- First submitted
- 7 Nov 2016
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
- ClinicalTrials.gov ID
- NCT02960087
- Acronym / sponsor ID
- PR19
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Study start
- 6 Mar 2017 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 LDR | Active comparator | Radiation: Low dose rate brachytherapyLow Dose Rate (LDR) brachytherapy with I-125 to a total dose of 144 Gy |
| Arm 3 HDR | Active comparator | Radiation: High dose rate brachytherapyHigh Dose Rate brachytherapy: 27 Gy in 2 fractions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose rate brachytherapyI-125 to a total dose of 144 Gy | Radiation | Arm 1 LDR |
| High dose rate brachytherapy27 Gy in 2 fractions | Radiation | Arm 3 HDR |
Primary outcome
Efficacy of HDR and LDR brachytherapy on prostate cancer control as defined by 48 month PSA values
Time frame: 48 months
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
4 secondary outcomes
Disease-free survival
Time frame: 7 years
Number and severity of adverse events
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
Time frame: 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Morton study chair
Sunnybrook Health Sciences, Toronto ON
Eric Vigneault study chair
Hotel Dieu de Quebec, Montreal, QC
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose rate brachytherapy and High dose rate brachytherapy in people with Prostate Carcinoma, run by Canadian Cancer Trials Group at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of HDR and LDR brachytherapy on prostate cancer control as defined by 48 month PSA values (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.