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Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up Men only

Adaptive vs non-adaptive radiotherapy and bladder filling directions for localized prostate cancer

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)

Run by British Columbia Cancer Agency · NCT06678126 · Data updated 2026-11-12

This trial tests whether daily adaptive radiotherapy plus customized bladder filling instructions improve outcomes for men with intermediate- or high-risk localized prostate cancer.

More Prostate Cancer trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment104 (estimated)
SponsorBritish Columbia Cancer Agency
Academic / other
Drugs / interventionsradiation
Locations1 site (Vancouver, British Columbia)
StatusRecruiting
StartedJanuary 16, 2026
Main results expectedJune 2033
Study endsJanuary 2035
Registry record updatedSeptember 18, 2026
Trial IDNCT06678126 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with NCCN intermediate- or high-risk localized prostate cancer, untreated with metastases, and suitable for moderate hypofractionated radiotherapy to pelvic nodes and the prostate.

Probably not a fit

Patients with less favorable anatomy, non-adherence to bladder instructions, or lack of benefit from adaptive planning may not experience improvement.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial compares standard non-adaptive radiotherapy to daily adaptive radiotherapy in combination with two different bladder filling instructions for patients with intermediate- or high-risk localized prostate cancer. Participants receive pelvic nodes and prostate radiotherapy with moderate hypofractionation (44 Gy to pelvic nodes and 60 Gy to the prostate in 20 fractions) per BC Cancer guidelines. The study uses a per-protocol follow-up schedule and blood work to monitor safety and treatment effects. Enrollment requires favorable baseline urinary continence, an IPSS score below 20, and willingness to adhere to adaptive treatment timing and follow-up. The goal is to determine if customization in bladder management and adaptive planning reduce side effects and improve treatment delivery.

Why it matters

Potential benefit: If successful, patients may experience fewer treatment-related side effects and more precise radiation delivery.

How similar studies have gone: Prior studies in adaptive radiotherapy and bladder management have shown potential benefits in select settings, but results vary by technique and patient characteristics.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • BC Cancer Vancouver
    Vancouver, British Columbia, Canada     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.