NCT06678126RecruitingPhase 2
Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients With Intermediate or High Risk Localized Prostate Cancer (ARP)
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)
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 4 Nov 2024
- Start date
- 16 Jan 2026
- Primary completion date
- Jun 2033
- Lead sponsor
- Scott Tyldesley
- Diseases
- Prostate cancer
- NCT number
- NCT06678126
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 104
- From 16 Jan 2026 to the primary completion date, Jun 2033
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic radiotherapy
- Prior transurethral resection of prostate or radical prostatectomy
- Prior pelvic radiotherapy.
Other illness
- 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
Other
- Indwelling urinary catheter.
- Hip prosthesis
- Unable to lie still on RT treatment couch for more than 30 minutes
- Clinical T3b or T4 tumours
- Presence of a pelvic kidney.
- Significant urinary incontinence: ie \> 1 soaked, or 2 non-soaked pads per day.
- Potentially fertile patient who are unwilling to employ highly effective contraception
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BC Cancer - Vancouver Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.