Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We will investigate whether ultrahypofractionation using stereotactic ablative radiotherapy (SABR) or brachytherapy is as well-tolerated as moderately hypofractionated external beam radiotherapy (EBRT) for treating the prostate in patients with oligometastatic prostate cancer. Secondary aims include assessment of progression-free survival (PFS) and overall survival (OS) as well as cost-effectiveness. We hypothesize that ultrahypofractionation will maintain favorable toxicity profiles and quality of life while achieving comparable or better efficacy, thereby providing a convenient and cost-effective alternative to moderately hypofractionated EBRT.
Men newly diagnosed with low volume oligometastatic prostate cancer defined as fewer than 5 bone metastases and/or non regional lymph node involvement who agree to treatment of the primary cancer with radiation will be randomized between standard moderately hypofractionated external radiotherapy (5500 centiGray/20 fractions as per Stampede trial) and one of 3 alternatives: stereotactic body radiotherapy (SABR) to deliver 36 Gy/5 fractions, or low dose rate Iodine 125 permanent seed implant or a single high dose rate temporary implant. The trial will take place in 4 regional cancer centers of British Columbia Cancer Agency, with each center choosing their preferred alternative to 5500/20. To achieve 4 equally sized treatment arms, each randomization is weighted 3:1 for 42 patients in each arm and 168 total accrual. The primary endpoint is urinary quality of life as assessed by the International Prostate Symptom Score (IPSS) . As the typical acute symptoms from each of these radiation modalities has a unique time course, assessments are done at 6 different points during the first 2 years. Secondary endpoints are global quality of life as assessed by Expanded Prostate Cancer Index (EPIC) urinary, bowel and sexual scores, progression free survival, overall survival and cost effectiveness.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard | Active Comparator | External beam radiotherapy to deliver 5500 centiGray (cGy) in 20 fractions to the prostate over 4 weeks |
|
| High dose rate brachytherapy | Experimental | A single fraction of 19 Gray (Gy) is delivered to the prostate under anesthesia as an out patient. |
|
| Permanent seed implant brachytherapy | Experimental | A single permanent implant of radioactive Iodine-125 seeds is performed under anesthesia as an out patient to deliver 125 Gy to the prostate |
|
| Stereotactic body radiotherapy | Experimental | 36.25 Gy is delivered to the prostate in 5 fractions given either weekly or every second day, using a SABR technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypofractionated external beam radiotherapy | Radiation | 5500 cGy/20 fractions delivered 5 days per week over 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary symptoms | International Prostate Symptom score (0/35), higher worse | Baseline to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Prostate Cancer Index (EPIC) urinary domain | Urinary Quality of life, 0/100 higher score better | Baseline to 2 years |
| EPIC bowel domain | Bowel quality of life, 0/100, higher score better. Series of validated questions concerning urgency, frequency, consistency, leakage, presence of blood and pain with bowel movements and then rates how big a problem each symptom was (0-5) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juanita Crook, MD | Contact | 250 712 3958 | jcrook@bccancer.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Juanita Crook, MD | BCCancer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Cancer Agency Center for the Southern Interior | Recruiting | Kelowna | British Columbia | V1Y5L3 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There is one standard arm (5500/20) and 3 alternative arms. The alternative arms are selected at the treating center. Thus, each randomization is 2-way, but with a 3:1 weighting so that the 4 treatment arms have equal numbers of patients.
Not provided
Not provided
Not provided
Not provided
| High dose rate brachytherapy | Radiation | A single fraction of 19 Gy is delivered from an automated afterloading Iridium-192 source via interstitial catheters placed under ultrasound guidance |
|
| Permanent seed implant | Radiation | Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance |
|
|
| Stereotactic body radiotherapy | Radiation | External radiation using SABR technology delivers 36.25 Gy to the prostate in 5 fractions given either once weekly for 5 weeks or every second day over 2 weeks. |
|
|
| Baseline to 2 years |
| EPIC sexual domain | Sexual quality of life, 0/100, higher score better. Series of validated questions concerning frequency and quality of erections, presence of morning erections, ability to engage in sexual activity or intercourse, rates ability and then rates importance of each issue to the patient. | Baseline to 2 years |
| Biochemical failure (time to increase in prostate specific antigen (ng/ml) to 50% > nadir | Progression free survival measured as time to Prostate Specific Antigen (PSA) rise by 50% > nadir | Baseline to 3 years |
| Distant metastatic failure | Progression free survival measured as time to new or progressive bone metastases | Baseline to 3 years |
| Nodal progression | Progression free survival measured as new or progressive adenopathy on imaging | Baseline to 3 years |
| Overall survival | Overall survival regardless of cause of death | 3 years |
| Cause specific survival | Death from prostate cancer | Within 3 years of treatment |
| Cost effectiveness | Analysis of primary treatment costs and secondary treatment costs at time of progression | 3 years |
| Fraser Valley Cancer Center | Not yet recruiting | Surrey | British Columbia | Canada |
|
| Vancouver Cancer Center | Recruiting | Vancouver | British Columbia | Canada |
|
| Vancouver Island Cancer Center | Recruiting | Victoria | British Columbia | Canada |
|
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided