Clinical trial NCT06678126: Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients with Intermediate or High Risk Localized Prostate Cancer (ARP)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adaptive radiotherapy
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Randomized Phase II 2 by 2 factorial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

  * 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:

* 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.
* 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

Primary outcomes:
measure: Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer.
timeFrame: Accrual period, estimated 3.5 years
Secondary outcomes:
measure: Measure and compare the patient reported Acute GU and GI bladder toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.
timeFrame: 5 years after participant completes RT
measure: Measure and compare the patient reported Late GU and GI bladder side effects associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.
timeFrame: 5 years after participant completes RT
measure: 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
timeFrame: 5 years after participant completes RT
measure: Determine which bladder filling instructions (BFI) are associated with daily shortest treatment time
timeFrame: approx 4 weeks during treatment of 20 fractions
measure: Determine which BFIs are associated with least rescan and repeat CBCT requirements
timeFrame: approx 4 weeks during treatment of 20 fractions
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Cancer Vancouver
state: British Columbia
Study officials:
References: