Carcinoma of the ProstatePhase 2NCT01890096
A Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
A Phase 2 study testing HDR 2 Fraction and HDR 1 Fraction in people with Carcinoma of the Prostate, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Carcinoma of the Prostate
- What is being tested?
- HDR 2 Fraction and HDR 1 Fraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to 1 May 2020
- 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
- histologically confirmed diagnosis of adenocarcinoma of the prostate
- low and intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA < 20ng/mL. PSA to be drawn within 60 days of registration
- prostate volume < 60 cc as determined by ultrasound, CT or MRI
- willing to give informed consent ot participate in this clinical trial
- able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
Who cannot join
- documented nodal or distant metastases
- previous pelvic radiotherapy
- previous trans-urethral resection of prostate, previous prostatectomy or Highly Focused Ultrasound (HIFU)
- use of androgen deprivation therapy. Use of 5-alpha reductase inhibitors is permitted
- poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease
- significant medical co-morbidity rendering patient unsuitable for general anaesthetic
Trial locations and contacts
1 site in 1 country.
Canada1 site
Odette Cancer Centre, Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: A Randomized Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.
- Conditions
- Carcinoma of the Prostate
- Being tested
- HDR 2 Fraction, HDR 1 Fraction
- Keywords
- HDR, monotherapy, low, intermediate, prostate cancer
- 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 2 FractionRadiation
High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin.
HDR 1 FractionRadiation
High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction
| Study group | Role | What they receive |
|---|---|---|
| HDR 2 fractions | Experimental | HDR brachytherapy of 27 Gy delivered in 2 fractions one week apart Receives: Radiation: HDR 2 Fraction |
| HDR 1 fraction | Experimental | HDR brachytherapy of 19 Gy delivered in a single fraction Receives: Radiation: HDR 1 Fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life (QoL)
To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy.
Measured: 1 year
Secondary outcomes (6)
GU and GI toxicities
To determine genito-urinary (GU) and gastro-intestinal (GI) toxicities in both study arms according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Measured: baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years
Urinary Symptoms
To determine changes in urinary symptoms in both study arms as determined by the International Prostate Symptom Score (IPSS)
Measured: baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years
Serum PSA changes
To determine changes in serum prostate-specific antigen (PSA) in both arms
Measured: baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years
Biochemical failure and disease free survival rates
To determine PSA failure and disease free survival rates in both study arms
Measured: 5 years
Erectile function
To determine changes in erectile function in both study arms assessed using the International Index of Erectile Function (IIEF) scale
Measured: 5 year
Associations between dosimetric parameters and toxicity/EPIC domains
To explore association between dosimetric parameters and toxicity/EPIC domain change
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startMay 2013
- Primary completion1 May 2017
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Gerard Morton, Sunnybrook Health Sciences Centre
- Investigators
- Gerard Morton, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01890096
- Sponsor's protocol ID
- GMOR_HDR Monotherapy RCT
- Status last verified
- Apr 2018
- First submitted
- 26 Jun 2013
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of High Dose-Rate Brachytherapy as Monotherapy in Low and Intermediate Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01890096
- Acronym / sponsor ID
- GMOR_HDR Monotherapy RCT
- Conditions
- Carcinoma of the Prostate
- Keywords
- HDR, monotherapy, low, intermediate, prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 1 Jul 2013 (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.
A single high dose rate brachytherapy (HDR) treatment combined with a short course of external beam radiotherapy (EBRT) is a highly effective and well tolerated treatment for men with intermediate risk prostate cancer. High cancer control rates have also been reported with HDR used on its own, without the EBRT. The challenge has been to determine what HDR dose to use with a move towards one or two fractions by several investigators. These schedules are reported to be well tolerated in the short term, but with little long term data. The objective of this study is to investigate HDR monotherapy given as either one fraction of 19 Gy or two fractions of 13.5 Gy in a randomized phase II clinical trial. The primary endpoint is patient reported toxicity and health related quality of life at 1 year, and efficacy data will be also be analyzed. Sample size for the study is 174 patients, which we expect to accrue within 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HDR 2 fractions | Experimental | Radiation: HDR 2 FractionHDR brachytherapy of 27 Gy delivered in 2 fractions one week apart |
| HDR 1 fraction | Experimental | Radiation: HDR 1 FractionHDR brachytherapy of 19 Gy delivered in a single fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- histologically confirmed diagnosis of adenocarcinoma of the prostate
- low and intermediate risk disease defined as either Gleason 6 or Gleason 7 and PSA < 20ng/mL. PSA to be drawn within 60 days of registration
- prostate volume < 60 cc as determined by ultrasound, CT or MRI
- willing to give informed consent ot participate in this clinical trial
- able and willing to complete Expanded Prostate Index Composite (EPIC) questionnaire
Key exclusion criteria (6 listed)
- documented nodal or distant metastases
- previous pelvic radiotherapy
- previous trans-urethral resection of prostate, previous prostatectomy or Highly Focused Ultrasound (HIFU)
- use of androgen deprivation therapy. Use of 5-alpha reductase inhibitors is permitted
- poor baseline urinary function defined as radiotherapy eg. connective tissue disease or inflammatory bowel disease
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 2 FractionHigh dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin. | Radiation | HDR 2 fractions |
| HDR 1 FractionHigh Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction | Radiation | HDR 1 fraction |
Primary outcome
Health related quality of life (QoL)
Time frame: 1 year
To demonstrate that health related QoL at 1 year in the urinary and bowel domains of the Expanded Prostate Index Composite (EPIC) for at least one HDR monotherapy arm is not worse than that following current standard treatment with single fraction HDR combined with supplemental external beam radiotherapy.
6 secondary outcomes
GU and GI toxicities
Time frame: baseline, 6 weeks post treament, 3mths, 6mths, 6 monthly for the first 3 years, annually up to 5 years
Urinary Symptoms
Time frame: baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly for the first 3 years, annually until 5 years
Serum PSA changes
Time frame: baseline, 6 weeks post treatment, 3 mths, 6 mths, 6-monthly up to 3 years, annually until 5 years
Biochemical failure and disease free survival rates
Time frame: 5 years
Erectile function
Time frame: 5 year
Associations between dosimetric parameters and toxicity/EPIC domains
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
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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, MD principal investigator
Sunnybrook Health Sciences Centre
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 2 Fraction and HDR 1 Fraction in people with Carcinoma of the Prostate, run by Sunnybrook Health Sciences Centre 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 5 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: status not confirmed, as of the sponsor's last update on 17 Apr 2018. 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?
Health related quality of life (QoL) (time frame: 1 year). 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 17 Apr 2018.