Prostate CancerNCT01982786
Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
A study testing Image guided external beam radiotherapy with or without brachytherapy boost and Brachytherapy in people with Prostate Cancer, run by Canadian Cancer Trials Group at 9 sites in Canada.
Trial summary
This research is being done because investigators involved in this study would like to compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy boost to see which treatment is better and what the side effects of treatment are. 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?
- Image guided external beam radiotherapy with or without brachytherapy boost and Brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 9 sitesCanada
- Study dates
- 22 Apr 2014to 19 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 prostate adenocarcinoma. The date of the last biopsy that verifies that the eligibility criterions have been met must be within 9 months prior to randomization. There must be no prior treatment.
- Intermediate-risk cancer patients based on the NCCN Guidelines (www.nccn.org):
- TNM classification:
- T2b-T2c and Gleason Score < 8/10 and PSA < 20 ng/ml; or
- T1c-T2a and Gleason Score 7/10 and PSA < 20 ng/ml; or
- T1c-T2a and Gleason Score ≤ 6/10 and 10 ≤ PSA < 20 ng/ml
Show all 20Show fewer
- For patients who have been on alpha reductase inhibitors within the last 6 months, use the following guidelines:
- T2b-T2c and Gleason Score < 8/10 and PSA ≤ 10 ng/ml; or
- T1c-T2a and Gleason Score 7/10 and PSA ≤ 10 ng/ml; or
- T1c-T2a and Gleason Score ≤ 6/10 and 5 ≤ PSA ≤ 10 ng/ml
- No alpha reductase inhibitors (i.e. avodart, proscar) use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization.
- Prostate volume ≤ 75 cc.
- American Urological Association (AUA) Symptom Index score < 20.
- Judged to be medically fit for IGRT and HDR brachytherapy boost by a radiation oncologist.
- ECOG Performance Status of 0 or 1.
- ≥ 18 years of age.
- 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. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves the patients registered on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
- Protocol treatment is to begin within 4 weeks of patient randomization. HDR brachytherapy boost treatment is to begin within 3 weeks before or after IGRT for those randomized to Arm 2.
- Participants must be willing to take precautions to prevent pregnancy while on treatment. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention). However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he is responsible for beginning contraceptive measures.
Who cannot join
- History of transurethral resection of the prostate (TURP).
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
- Prior or current bleeding diathesis.
- Prior pelvic or prostate radiotherapy.
- Previous history of (or planned) androgen deprivation therapy.
- Evidence of metastatic disease.
- Any serious active disease or co-morbid medical condition, 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
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
McGill University - Dept. Oncology
Montreal, Quebec, H2W 1S6
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
About this study
Official title: Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
This research is being done because investigators involved in this study would like to compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy boost to see which treatment is better and what the side effects of treatment are.
Read the detailed description
Before a big study is done, a smaller study (called a "feasibility study") is required to make sure that patients and physicians are willing to participate in a study comparing the two kinds of treatments, and to verify how the radiation therapy is given in different centres across Canada.
The standard or usual treatment for this disease includes treatment with IGRT or IGRT plus HDR brachytherapy boost.
- Conditions
- Prostate Cancer
- Being tested
- Image guided external beam radiotherapy with or without brachytherapy boost, 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.
Image guided external beam radiotherapy with or without brachytherapy boostRadiation
image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
BrachytherapyRadiation
Brachytherapy boost
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Receives: Radiation: Image guided external beam radiotherapy with or without brachytherapy boost |
| Arm 2 | Active comparator | IGRT 37.5 Gy in 15 fractions
+ HDR brachytherapy boost 15 Gy Receives: Radiation: Image guided external beam radiotherapy with or without brachytherapy boost; Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Ability to Accrue Patients
The ability to accrue 60 patients over an 18 month period to a study that randomizes men with intermediate-risk prostate cancer to curative intent treatment with image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost within a Canadian multicentre setting.
Measured: 21 months
Secondary outcomes (3)
Number of Participants Reported Adverse Events
Acute genitourinary (GU) and gastrointestinal (GI) adverse events.
Measured: 21 months
Treatment Compliance
Treatment compliance will be monitored on an ongoing basis by Central Office and the designated radiotherapy quality assurance reviewer and will be described for both arms.
Measured: 21 months
Radiotherapy Quality Assurance -Timing
The time from the the time from IGRT Real Time Review Signed to IGRT Real Time Review Uploaded.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start22 Apr 2014
- Primary completion5 Jul 2016
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Eric Vigneault, Study chair, CHUQ - Hotel Dieu de Quebec, Quebec QCDouglas Loblaw, Study chair, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto On
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982786
- Sponsor's protocol ID
- PR15
- Status last verified
- Mar 2017
- First submitted
- 6 Nov 2013
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vigneault E, Morton G, Parulekar WR, Niazi TM, Springer CW, Barkati M, Chung P, Koll W, Kamran A, Monreal M, Ding K, Loblaw A. Randomised Phase II Feasibility Trial of Image-guided External Beam Radiotherapy With or Without High Dose Rate Brachytherapy Boost in Men with Intermediate-risk Prostate Cancer (CCTG PR15/ NCT01982786). Clin Oncol (R Coll Radiol). 2018 Sep;30(9):527-533. doi: 10.1016/j.clon.2018.05.007. Epub 2018 Jun 11.
PubMed 29903505
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT01982786
- Acronym / sponsor ID
- PR15
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Study start
- 22 Apr 2014 (actual)
- Primary completion
- 5 Jul 2016 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 22 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done because investigators involved in this study would like to compare image guided external beam radiation therapy (IGRT) to IGRT plus HDR brachytherapy boost to see which treatment is better and what the side effects of treatment are.
Detailed description
Before a big study is done, a smaller study (called a "feasibility study") is required to make sure that patients and physicians are willing to participate in a study comparing the two kinds of treatments, and to verify how the radiation therapy is given in different centres across Canada.
The standard or usual treatment for this disease includes treatment with IGRT or IGRT plus HDR brachytherapy boost.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Radiation: Image guided external beam radiotherapy with or without brachytherapy boostIGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions |
| Arm 2 | Active comparator | Radiation: Image guided external beam radiotherapy with or without brachytherapy boost, Radiation: BrachytherapyIGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically confirmed prostate adenocarcinoma. The date of the last biopsy that verifies that the eligibility criterions have been met must be within 9 months prior to randomization. There must be no prior treatment.
- Intermediate-risk cancer patients based on the NCCN Guidelines (www.nccn.org):
- T2b-T2c and Gleason Score < 8/10 and PSA < 20 ng/ml; or
- T1c-T2a and Gleason Score 7/10 and PSA < 20 ng/ml; or
- T1c-T2a and Gleason Score ≤ 6/10 and 10 ≤ PSA < 20 ng/ml
Key exclusion criteria (7 listed)
- History of transurethral resection of the prostate (TURP).
- Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
- Prior or current bleeding diathesis.
- Prior pelvic or prostate radiotherapy.
- Previous history of (or planned) androgen deprivation therapy.
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 |
|---|---|---|
| Image guided external beam radiotherapy with or without brachytherapy boostimage guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost | Radiation | Arm 1, Arm 2 |
| BrachytherapyBrachytherapy boost | Radiation | Arm 2 |
Primary outcome
Feasibility of Ability to Accrue Patients
Time frame: 21 months
The ability to accrue 60 patients over an 18 month period to a study that randomizes men with intermediate-risk prostate cancer to curative intent treatment with image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost within a Canadian multicentre setting.
3 secondary outcomes
Number of Participants Reported Adverse Events
Time frame: 21 months
Treatment Compliance
Time frame: 21 months
Radiotherapy Quality Assurance -Timing
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29903505Vigneault E, Morton G, Parulekar WR, Niazi TM, Springer CW, Barkati M, Chung P, Koll W, Kamran A, Monreal M, Ding K, Loblaw A. Randomised Phase II Feasibility Trial of Image-guided External Beam Radiotherapy With or Without High Dose Rate Brachytherapy Boost in Men with Intermediate-risk Prostate Cancer (CCTG PR15/ NCT01982786). Clin Oncol (R Coll Radiol). 2018 Sep;30(9):527-533. doi: 10.1016/j.clon.2018.05.007. Epub 2018 Jun 11.
- 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.
Eric Vigneault study chair
CHUQ - Hotel Dieu de Quebec, Quebec QC
Douglas Loblaw study chair
Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto On
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image guided external beam radiotherapy with or without brachytherapy boost and Brachytherapy in people with Prostate Cancer, run by Canadian Cancer Trials Group at 9 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 20 inclusion and 7 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: finished, as of the sponsor's last update on 13 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 9 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?
Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Ability to Accrue Patients (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01982786, which also lists 1 linked publication.
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 13 Apr 2026.