Trial comparing treatments 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)
ClinicalTrials.gov ID: NCT06678126
What this study is testing
- What it's testing
- This study compares two radiation methods and two sets of bladder instructions to see which combination causes fewer side effects.
- Who it's for
- The study is looking for people with intermediate or high-risk localized prostate cancer.
- What's involved
- Participants will receive radiation therapy and follow specific instructions on how much to fill their bladder before each session.
- Time commitment
- The source text does not specify the total duration or number of visits required.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility 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.
- 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...
- Potentially fertile patient who are unwilling to employ highly effective contraception
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.