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The study is being done to compare the side effects between two different radiation techniques, standard non-adaptive radiation therapy vs. daily adaptive radiation therapy and also comparing two different bladder filling instructions to find out if customized bladder instructions may lead to better treatment outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1i | Active Comparator | Adaptive RT & Standard Bladder Filling Instructions |
|
| Arm 1ii | Active Comparator | Adaptive RT and Custom Bladder Filling Instructions |
|
| Arm 2i | Active Comparator | Non Adaptive RT and Standard Bladder Filling Instructions |
|
| Arm 2ii | Active Comparator | Non Adaptive RT and Custom Bladder Filling Instructions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostate and Pelvic Nodes Radiotherapy | Radiation | 60 Gy prostate and 44 Gy pelvic nodes with 20 fractions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer. | Accrual and randomization rate will be captured in REDCap database until the goal of 104 participants are randomized. With the accrual rate, we may imply it is feasible to do a larger more definitive and timely randomized control trial. | Accrual period, estimated 3.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measure and compare the patient reported Acute GU and GI bladder toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer. | using Patient reported questionnaire (POSI) to review toxicities at 1.5 months, 6 months, and years 1,2,5 post study RT. | 5 years after participant completes RT |
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Inclusion Criteria:
Age ≥ 18
Pathological diagnosis of a primary prostate adenocarcinoma
NCCN Intermediate or high risk localized prostate cancer and clinically N0 and M0 by conventional imaging
Intermediate: one or more of cT2b-T2c, PSA 10-20, or Gleason Group 2 or 3
Able to complete BC Cancer POSI questionnairesWilling to attend adaptive treatment slot timing as required by treating centre.
Willing and able to have regular per protocol follow up and blood work
Feasible to start protocol treatment within 120 calendar days of participant enrolment
Continent of urine (or able to maintain continence with penile clamp/cuff during RT as needed) and able to follow bladder filling instructions.
Baseline IPSS score < 20 at time of enrolment.
ECOG performance Status : 0-2.
Nodal risk ≥ 20% using the Memorial Sloan Kettering Nodal Risk Nomogram (https://www.mskcc.org/nomograms/prostate/pre\_op).
Negative for bone metastases on bone scan within 3 months of enrolment
No involved nodes on Abdomen and pelvic CT or pelvic MRI within 3 months of enrolment.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandy Chang | Contact | 604-675-4100 | 202199 | sandy.chang@bccancer.bc.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer Vancouver | Vancouver | British Columbia | V5Z4E6 | Canada |
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Randomized Phase II 2 by 2 factorial
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| Measure and compare the patient reported Late GU and GI bladder side effects associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer. |
using Patient reported questionnaire (POSI) to review toxicities at 1.5 months, 6 months, and years 1,2,5 post study RT. |
| 5 years after participant completes RT |
| Measure and compare the physician reported CTCAE Acute (6 weeks post RT) GU and GI bladder CTCAE toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer | review toxicities at 1.5 months, 6 months, and years 1,2,5 post study RT. | 5 years after participant completes RT |
| Determine which bladder filling instructions (BFI) are associated with daily shortest treatment time | using treatment time record during the 20 fractions | approx 4 weeks during treatment of 20 fractions |
| Determine which BFIs are associated with least rescan and repeat CBCT requirements | using records from treatment | approx 4 weeks during treatment of 20 fractions |
| 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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