Prostate CancerPhase 2NCT06678126
Adaptive Versus Non-adaptive Radiotherapy and 2 Bladder Filling Instructions for Patients With Intermediate or High Risk Localized Prostate Cancer (ARP)
A Phase 2 study testing Prostate and Pelvic Nodes Radiotherapy in people with Prostate Cancer, run by Scott Tyldesley at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate and Pelvic Nodes Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jan 2026to Jan 2035
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
BC Cancer Vancouver
Vancouver, British Columbia, V5Z4E6
Armin Mardani, MD, MSc, 6048776000 ext. 676198, Armin.mardani@bccancer.bc.ca
Scott Tyldesley, MD FRCPC
About this study
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)
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
- Being tested
- Prostate and Pelvic Nodes Radiotherapy
- Keywords
- adaptive radiotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate and Pelvic Nodes RadiotherapyRadiation
60 Gy prostate and 44 Gy pelvic nodes with 20 fractions
| Study group | Role | What they receive |
|---|---|---|
| Arm 1i | Active comparator | Adaptive RT \& Standard Bladder Filling Instructions Receives: Radiation: Prostate and Pelvic Nodes Radiotherapy |
| Arm 1ii | Active comparator | Adaptive RT and Custom Bladder Filling Instructions Receives: Radiation: Prostate and Pelvic Nodes Radiotherapy |
| Arm 2i | Active comparator | Non Adaptive RT and Standard Bladder Filling Instructions Receives: Radiation: Prostate and Pelvic Nodes Radiotherapy |
| Arm 2ii | Active comparator | Non Adaptive RT and Custom Bladder Filling Instructions Receives: Radiation: Prostate and Pelvic Nodes Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Accrual period, estimated 3.5 years
Secondary outcomes (5)
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.
Measured: 5 years after participant completes RT
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.
Measured: 5 years after participant completes RT
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.
Measured: 5 years after participant completes RT
Determine which bladder filling instructions (BFI) are associated with daily shortest treatment time
using treatment time record during the 20 fractions
Measured: approx 4 weeks during treatment of 20 fractions
Determine which BFIs are associated with least rescan and repeat CBCT requirements
using records from treatment
Measured: approx 4 weeks during treatment of 20 fractions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start16 Jan 2026
- Primary completionJun 2033 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomized Phase II 2 by 2 factorial
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scott Tyldesley
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Scott Tyldesley, British Columbia Cancer Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678126
- Sponsor's protocol ID
- ARP
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06678126
- Acronym / sponsor ID
- ARP
- Conditions
- Prostate Cancer
- Keywords
- adaptive radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Scott TyldesleyUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- Jun 2033 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized Phase II 2 by 2 factorial
| Arm | Type | Receives |
|---|---|---|
| Arm 1i | Active comparator | Radiation: Prostate and Pelvic Nodes RadiotherapyAdaptive RT \& Standard Bladder Filling Instructions |
| Arm 1ii | Active comparator | Radiation: Prostate and Pelvic Nodes RadiotherapyAdaptive RT and Custom Bladder Filling Instructions |
| Arm 2i | Active comparator | Radiation: Prostate and Pelvic Nodes RadiotherapyNon Adaptive RT and Standard Bladder Filling Instructions |
| Arm 2ii | Active comparator | Radiation: Prostate and Pelvic Nodes RadiotherapyNon Adaptive RT and Custom Bladder Filling Instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Able to complete BC Cancer POSI questionnairesWilling to attend adaptive treatment slot timing as required by treating centre.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate and Pelvic Nodes Radiotherapy60 Gy prostate and 44 Gy pelvic nodes with 20 fractions | Radiation | Arm 1i, Arm 1ii, Arm 2i, Arm 2ii |
Primary outcome
Assess the feasibility of randomization to adaptive vs standard radiotherapy localized high-risk prostate cancer.
Time frame: Accrual period, estimated 3.5 years
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.
5 secondary outcomes
Measure and compare the patient reported Acute GU and GI bladder toxicity associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.
Time frame: 5 years after participant completes RT
Measure and compare the patient reported Late GU and GI bladder side effects associated standard (SRT) and Adaptive (ART) radiotherapy for localized prostate cancer.
Time frame: 5 years after participant completes RT
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
Time frame: 5 years after participant completes RT
Determine which bladder filling instructions (BFI) are associated with daily shortest treatment time
Time frame: approx 4 weeks during treatment of 20 fractions
Determine which BFIs are associated with least rescan and repeat CBCT requirements
Time frame: approx 4 weeks during treatment of 20 fractions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prostate and Pelvic Nodes Radiotherapy in people with Prostate Cancer, run by Scott Tyldesley at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Armin Mardani, MD, MSc (604-877-6000 ext. 676198, armin.mardani@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.