Prostate cancer radiation showdown: which treatment wins?
NCT ID NCT01982786
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared two types of radiation therapy for men with intermediate-risk prostate cancer: standard image-guided external beam radiation (IGRT) versus IGRT plus a high-dose-rate brachytherapy boost. The goal was to see which treatment works better and what side effects occur. Fifty-seven men took part, and the study focused on how feasible it was to enroll patients and track side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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57 people
The number who actually took part.
- Started
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Apr 2014
- Finished
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Oct 2018
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 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. Exclusion Criteria: * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
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CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
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Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
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Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9, Canada
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McGill University - Dept. Oncology
Montreal, Quebec, H2W 1S6, Canada
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Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
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Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
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Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
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Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains