Randomized Phase II 2 by 2 Factorial Trial of Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients with Intermediate or High Risk Localized Prostate Cancer (ARP)

Scott Tyldesley1 site in 1 country104 target enrollmentApril 2025

ConditionsProstate Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Scott Tyldesley
Enrollment: 104
Locations: 1
Primary Endpoint: Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer.
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 2025

End Date

January 2035

Last Updated

last year

Study Type

Interventional

Study Design

Factorial

Sex

Male

Investigators

Sponsor

Scott Tyldesley

Responsible Party

Sponsor Investigator

Principal Investigator

Scott Tyldesley

MD MPA ABR FRCPC

British Columbia Cancer Agency

Eligibility Criteria

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
•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.

Exclusion Criteria

•Indwelling urinary catheter.
•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.

Outcomes

Primary Outcomes

Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer.

Time Frame: Accrual period, estimated 3.5 years

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.

Secondary Outcomes

Measure and compare the patient reported Acute GU and GI bladder toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.(5 years after participant completes RT)
Measure and compare the patient reported Late GU and GI bladder side effects associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.(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(5 years after participant completes RT)
Determine which bladder filling instructions (BFI) are associated with daily shortest treatment time(approx 4 weeks during treatment of 20 fractions)
Determine which BFIs are associated with least rescan and repeat CBCT requirements(approx 4 weeks during treatment of 20 fractions)