Recruiting
Phase 2

Radiation Techniques

Sponsor:

Scott Tyldesley

Code:

NCT06678126

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prostate and Pelvic Nodes Radiotherapy

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT06678126

Start date

Jan 16, 2026

Status verified date

Apr, 2026

Completion date

Jan, 2035

Anticipated

Primary completion date

Jun, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1i

Adaptive RT \& Standard Bladder Filling Instructions

active comparator: Arm 1ii

Adaptive RT and Custom Bladder Filling Instructions

active comparator: Arm 2i

Non Adaptive RT and Standard Bladder Filling Instructions

active comparator: Arm 2ii

Non Adaptive RT and Custom Bladder Filling Instructions

Interventions

Prostate and Pelvic Nodes Radiotherapy

60 Gy prostate and 44 Gy pelvic nodes with 20 fractions

Primary outcome measure

  • Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer. [ Time Frame: Accrual period, estimated 3.5 years ]

Central Contacts and Locations

Central contacts

Armin Mardani, MD, MSc

604-877-6000armin.mardani@bccancer.bc.ca

Locations

BC Cancer Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

Contacts

Armin Mardani, MD, MSc

6048776000Armin.mardani@bccancer.bc.ca

Principal Investigator:

Scott Tyldesley, MD FRCPC

More Information

Sponsor

Scott Tyldesley

Last update posted

Sep 18, 2026

Last verified

Apr, 2026

Keywords

  • adaptive radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Scott Tyldesley on 2026-09-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.