Prostate CancerPhase 2NCT02077335
Study of High-dose Rate (HDR) Monotherapy for Low and Intermediate Risk Prostate Cancer
A Phase 2 study testing HDR brachytherapy monotherapy in people with Prostate Cancer, run by CSSS de Gatineau at 1 site in Canada.
Trial summary
The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HDR brachytherapy monotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Biopsy proven Adenocarcinoma of the Prostate
- Clinical stage T1c, T2a or T2b
- PSA less than 20 ng/ml
- Gleason Score 6 or 7
Who cannot join
- Age less than 18 years
- Clinical stage T2c, T3 ou T4
- Clinical Stage N1
- Clinical Stage M1
- Prostate Specific Antigen (PSA) more than 20 ng/ml
- Gleason score 8 or higher
Show all 11Show fewer
- IPSS score 19 or higher with alpha-blockers
- Past radiation therapy to the pelvis
- History of Collagen Vascular Disease
- History of Inflammatory Bowel Disease
- Bilateral Hip Prosthesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer
The purpose of this study is to determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- HDR brachytherapy monotherapy
- Keywords
- Brachytherapy, Monotherapy, HDR
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDR brachytherapy monotherapyRadiation
Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following:
Prostate :
- V100 > 95%
- V150 30-35%
- V200 < 15%
- D90 > 90% (12,15Gy)
Bladder
- V75 < 1cc
Rectum
- V75 < 1cc
Urethra
V125 = 0cc D10 < 120%
Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| HDR brachytherapy monotherapy | Experimental | Radiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments. Receives: Radiation: HDR brachytherapy monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.
Measured: 5 years
Secondary outcomes (1)
Genito-urinary (GU) toxicity
Toxicity according to International prostate symptom score (IPSS) and Expanded Prostate Index Composite (EPIC) questionnaires.
Measured: 6 weeks, 2 years and 5 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSSS de Gatineau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Gaudet, CSSS de Gatineau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077335
- Sponsor's protocol ID
- CSSSG-001
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2014
- Last updated
- 21 Feb 2024
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of High-dose Rate (HDR) Monotherapy for the Treatment of Low and Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT02077335
- Acronym / sponsor ID
- CSSSG-001
- Conditions
- Prostate Cancer
- Keywords
- Brachytherapy, Monotherapy, HDR
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CSSS de GatineauUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 4 Mar 2014 (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 determine the clinical efficacy and toxicity of High-dose rate (HDR) brachytherapy as monotherapy for the treatment of low risk and intermediate risk prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDR brachytherapy monotherapy | Experimental | Radiation: HDR brachytherapy monotherapyRadiation therapy: Treatment with 2 separate HDR brachytherapy implants, each with one fraction of 13.5 Gray (Gy) with an interval of 7-14 days between treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biopsy proven Adenocarcinoma of the Prostate
- Clinical stage T1c, T2a or T2b
- PSA less than 20 ng/ml
- Gleason Score 6 or 7
Key exclusion criteria (11 listed)
- Age less than 18 years
- Clinical stage T2c, T3 ou T4
- Clinical Stage N1
- Clinical Stage M1
- Prostate Specific Antigen (PSA) more than 20 ng/ml
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 |
|---|---|---|
| HDR brachytherapy monotherapyRadiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following: Prostate : * V100 > 95% * V150 30-35% * V200 < 15% * D90 > 90% (12,15Gy) Bladder • V75 < 1cc Rectum • V75 < 1cc Urethra V125 = 0cc D10 < 120% Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure. | Radiation | HDR brachytherapy monotherapy |
Primary outcome
Disease-free survival
Time frame: 5 years
Disease free survival as evaluated by absence of biochemical recurrence (Phoenix criteria) and absence of clinically/radiologically diagnosed local, regional or distant recurrence.
1 secondary outcome
Genito-urinary (GU) toxicity
Time frame: 6 weeks, 2 years and 5 years post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HDR brachytherapy monotherapy in people with Prostate Cancer, run by CSSS de Gatineau at 1 site 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Disease-free survival (time frame: 5 years). 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 21 Feb 2024.