Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients with Intermediate or High Risk Localized Prostate Cancer (ARP)
NCT ID: NCT06678126
Last Updated: 2024-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
104 participants
INTERVENTIONAL
2025-04-30
2035-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Arm 1i
Adaptive RT \& Standard Bladder Filling Instructions
Prostate and Pelvic Nodes Radiotherapy
60 Gy prostate and 44 Gy pelvic nodes with 20 fractions
Arm 1ii
Adaptive RT and Custom Bladder Filling Instructions
Prostate and Pelvic Nodes Radiotherapy
60 Gy prostate and 44 Gy pelvic nodes with 20 fractions
Arm 2i
Non Adaptive RT and Standard Bladder Filling Instructions
Prostate and Pelvic Nodes Radiotherapy
60 Gy prostate and 44 Gy pelvic nodes with 20 fractions
Arm 2ii
Non Adaptive RT and Custom Bladder Filling Instructions
Prostate and Pelvic Nodes Radiotherapy
60 Gy prostate and 44 Gy pelvic nodes with 20 fractions
Interventions
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Prostate and Pelvic Nodes Radiotherapy
60 Gy prostate and 44 Gy pelvic nodes with 20 fractions
Eligibility Criteria
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Inclusion Criteria
* 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
* High: one or more of: cT3a, PSA \> 20, or Gleason Group 4 or 5.
* Consented to RT with moderate hypofractionated RT to pelvic nodes (44 Gy) and prostate (60Gy) in 20 fractions using standard BC Cancer regimen
* 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
* Hip prosthesis
* Prior pelvic radiotherapy
* Unable to lie still on RT treatment couch for more than 30 minutes
* Clinical T3b or T4 tumours
* Prior transurethral resection of prostate or radical prostatectomy
* Presence of a pelvic kidney.
* Prior pelvic radiotherapy.
* Significant urinary incontinence: ie \> 1 soaked, or 2 non-soaked pads per day.
* Inflammatory bowel disease, systemic lupus erythematosis, scleroderma, or other connective tissue disorders other than rheumatoid arthritis.
* Metastatic disease identified on staging investigations.
* Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the participant's safety, preclude safe administration of the planned protocol treatment, or prevent the participant from being managed according to the protocol guidelines
* Potentially fertile patient who are unwilling to employ highly effective contraception
18 Years
MALE
No
Sponsors
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Scott Tyldesley
OTHER
Responsible Party
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Scott Tyldesley
MD MPA ABR FRCPC
Locations
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BC Cancer Vancouver
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Scott Tyldesley, MD FRCPC
Role: backup
Other Identifiers
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ARP
Identifier Type: -
Identifier Source: org_study_id
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