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RecruitingNCT06678126Updated Sep 18, 2026

Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients With Intermediate or High Risk Localized Prostate Cancer (ARP)

A Phase 2 interventional study of Prostate and Pelvic Nodes Radiotherapy in Prostate Cancer, sponsored by Scott Tyldesley. Recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Scott Tyldesley · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
104
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • adaptive radiotherapy
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 104 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

This is the only study on the registry with Scott Tyldesley as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
104 participants (estimated)

Study arms

  • Active comparator
    Arm 1i

    Adaptive RT \& Standard Bladder Filling Instructions

    Radiation: Prostate and Pelvic Nodes Radiotherapy

  • Active comparator
    Arm 1ii

    Adaptive RT and Custom Bladder Filling Instructions

    Radiation: Prostate and Pelvic Nodes Radiotherapy

  • Active comparator
    Arm 2i

    Non Adaptive RT and Standard Bladder Filling Instructions

    Radiation: Prostate and Pelvic Nodes Radiotherapy

  • Active comparator
    Arm 2ii

    Non Adaptive RT and Custom Bladder Filling Instructions

    Radiation: Prostate and Pelvic Nodes Radiotherapy

Interventions

  • RadiationProstate and Pelvic Nodes Radiotherapy

    60 Gy prostate and 44 Gy pelvic nodes with 20 fractions

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: Accrual period, estimated 3.5 years

Secondary outcomes

  1. Measure and compare the patient reported Acute GU and GI bladder toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.

    using Patient reported questionnaire (POSI) to review toxicities at 1.5 months, 6 months, and years 1,2,5 post study RT.

    Time frame: 5 years after participant completes RT

  2. Measure and compare the patient reported Late GU and GI bladder side effects associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.

    using Patient reported questionnaire (POSI) to review toxicities at 1.5 months, 6 months, and years 1,2,5 post study RT.

    Time frame: 5 years after participant completes RT

  3. 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

    review toxicities at 1.5 months, 6 months, and years 1,2,5 post study RT.

    Time frame: 5 years after participant completes RT

  4. Determine which bladder filling instructions (BFI) are associated with daily shortest treatment time

    using treatment time record during the 20 fractions

    Time frame: approx 4 weeks during treatment of 20 fractions

  5. Determine which BFIs are associated with least rescan and repeat CBCT requirements

    using records from treatment

    Time frame: approx 4 weeks during treatment of 20 fractions

07

Study locations

1 of 1 sites recruiting
  • BC Cancer Vancouver
    Vancouver, British Columbia V5Z4E6, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06678126
Lead sponsor
Scott Tyldesley
Responsible party
Scott Tyldesley (MD MPA ABR FRCPC, British Columbia Cancer Agency) — Sponsor-investigator
First posted
Nov 7, 2024
Start date
Jan 16, 2026
Primary completion
Jun 2033 (estimated)
Completion
Jan 2035 (estimated)
Last update
Sep 18, 2026

Study contacts

Armin Mardani, MD, MSc
Contact
armin.mardani@bccancer.bc.ca
604-877-6000 ext. 676198

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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