Comparing 4 approaches for prostate cancer
Official title: 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)
- Phase 2
- 4 groups
- One site, in Vancouver
- Recruiting
Interventions
- Radiation therapy
Prostate and Pelvic Nodes Radiotherapy
60 Gy prostate and 44 Gy pelvic nodes with 20 fractions
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
BC Cancer Vancouver
Vancouver, British Columbia
Eligibility Criteria
See who this study is looking for27 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Intermediate: one or more of cT2b-T2c, PSA 10-20, or Gleason Group 2 or 3
- +ECOG performance Status : 0-2.
- +Pathological diagnosis of a primary prostate adenocarcinoma
- +NCCN Intermediate or high risk localized prostate cancer and clinically N0 and M0 by conventional imaging
- +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 protocolProtocolThe detailed plan a study must follow.Read more → follow upFollow-upContinued check-ins after the treatment part is finished.Read more → and blood work
- +Feasible to start protocol treatment within 120 calendar days of participant enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
- +Continent of urine (or able to maintain continence with penile clamp/cuff during RT as needed) and able to follow bladder filling instructions.
- +BaselineBaselineYour starting measurements, taken before treatment begins.Read more → IPSS score \< 20 at time of enrolment.
- +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
- −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → to compromise the participant's safety, preclude safe administration of the planned protocolProtocolThe detailed plan a study must follow.Read more → treatment, or prevent the participant from being managed according to the protocol guidelines
- −Potentially fertile patient who are unwilling to employ highly effective contraception
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 4 groups in this study.
Groups A, B, C and D, the comparison group, receive Prostate and Pelvic Nodes Radiotherapy.
Registry label: A: Arm 1i · B: Arm 1ii · C: Arm 2i · D: Arm 2ii
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists male participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 104 people.
The study is currently expected to finish around January 2035.
The main measurement is taken over: AccrualEnrolmentThe number of participants a study plans to include, or has included.Read more → period, estimated 3.5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Assess the feasibility of randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → to adaptive vs standard radiotherapy localized high-risk prostate cancer — measured over AccrualEnrolmentThe number of participants a study plans to include, or has included.Read more → period, estimated 3.5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06678126 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Prostate and Pelvic Nodes RadiotherapyRadiation
60 Gy prostate and 44 Gy pelvic nodes with 20 fractions
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists male participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: AccrualEnrolmentThe number of participants a study plans to include, or has included.Read more → period, estimated 3.5 years.
The study as a whole is currently expected to finish around 2035-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 104 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.