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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Active Comparator | IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions |
|
| Arm 2 | Active Comparator | IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image guided external beam radiotherapy with or without brachytherapy boost | Radiation | image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 21 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reported Adverse Events | Acute genitourinary (GU) and gastrointestinal (GI) adverse events. | 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. |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Vigneault | CHUQ - Hotel Dieu de Quebec, Quebec QC | Study Chair |
| Douglas Loblaw | Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto On | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. H. Bliss Murphy Cancer Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada | ||
| Royal Victoria Regional Health Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29903505 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost |
| FG001 | Arm 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Brachytherapy | Radiation | Brachytherapy boost |
|
| 21 months |
| Radiotherapy Quality Assurance -Timing | The time from the the time from IGRT Real Time Review Signed to IGRT Real Time Review Uploaded. | 5 months |
| Barrie |
| Ontario |
| L4M 6M2 |
| Canada |
| Lakeridge Health Oshawa | Oshawa | Ontario | L1G 2B9 | Canada |
| Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Univ. Health Network-Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Windsor Regional Cancer Centre | Windsor | Ontario | N8W 2X3 | Canada |
| CHUM - Hopital Notre-Dame | Montreal | Quebec | H2L 4M1 | Canada |
| McGill University - Dept. Oncology | Montreal | Quebec | H2W 1S6 | Canada |
| CHUQ-Pavillon Hotel-Dieu de Quebec | Québec | Quebec | G1R 2J6 | Canada |
IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost |
| BG001 | Arm 2 | IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Prostate Carcinoma Disease clinical T Stage | Prostate Carcinoma Disease clinical T Stage, higher stage reprent worse disease | Count of Participants | Participants |
| ||||||||||||||||||
| PSA | Count of Participants | Participants |
| |||||||||||||||||||
| The AUA Symptom Index Score | The AUA Symptom Index Score, measures the bothersome the urinary symptoms. Higher value indicates of worse symptom. | Count of Participants | Participants |
| ||||||||||||||||||
| combined Gleason Score | label the severity and stage of the prostate cancer, with higher value, the worse of the disease | Count of Participants | Participants |
| ||||||||||||||||||
| The ECOG Scale of Performance Status | The ECOG Scale of Performance Status, 0 indicates Fully active, while 5 means dead. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 21 months |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants Reported Adverse Events | Acute genitourinary (GU) and gastrointestinal (GI) adverse events. | As treated population | Posted | Count of Participants | Participants | 21 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 21 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Radiotherapy Quality Assurance -Timing | The time from the the time from IGRT Real Time Review Signed to IGRT Real Time Review Uploaded. | As treated population. | Posted | Median | Full Range | Day | 5 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | IGRT* 60 Gy in 20 fractions OR IGRT 78 Gy in 39 fractions Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost | 1 | 29 | 1 | 29 | 0 | 29 |
| EG001 | Arm 2 | IGRT 37.5 Gy in 15 fractions + HDR brachytherapy boost 15 Gy Image guided external beam radiotherapy with or without brachytherapy boost: image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost Brachytherapy: Brachytherapy boost | 2 | 26 | 2 | 26 | 0 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hematuria | Renal and urinary disorders | Systematic Assessment |
|
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Limited follow up time, delayed side effect might not be captured.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Keyue Ding | Canadian cancer trials group | 1-613-533-6000 | 77705 | kding@ctg.queensu.ca |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Title | Measurements |
|---|---|
|
| Male |
|
| T2a |
|
| T2b |
|
| T2c |
|
| 10-20 |
|
| AUA score from 10 to 19 |
|
| Others |
|
| Missing |
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