Trial comparing treatments for Prostate Cancer
Official title Focal Versus Whole Gland High Dose-Rate Brachytherapy (HDR-BT) Boost to External Beam Radiotherapy in Localized Prostate Cancer: A Phase 2 Randomized Trial
ClinicalTrials.gov ID: NCT07300566
What this study is testing
- Who it's for
- You may be able to join if you have intermediate or high-risk prostate cancer with a clear spot on an MRI.
- What's involved
- You would get radiation to the whole gland. Then, you would get a boost to either just the tumor or the whole gland.
- Time commitment
- The source text does not say how long the study lasts or how many visits are needed.
Which group you join is decided by chance.
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
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Eastern Co-Operative Oncology Group (ECOG) 0-2
- defined as clinical stage tumor cT1 or cT2a, International Society of Urological Pathology (ISUP) grade group 2-4 in less than or equal to 50% of the...
- corresponding to an Identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting...
- Prostate volume less than or equal to 60 cc is recommended. Transrectal ultrasound (TRUS) and magnetic resonance imaging (MRI) are accepted to assess...
You likely can't join if
- Contraindications to mpMRI
- Documented nodal or distant metastases
- Previous pelvic radiotherapy
- Recent transurethral resection of prostate (less than or equal to 6 months), previous prostatectomy or high-intensity focused ultrasound (HIFU)
- Poor baseline urinary function: International Prostate Symptom Score (IPSS) greater than 19
- Connective tissue disease or inflammatory bowel disease
See the full eligibility criteria
- Histologically confirmed diagnosis of adenocarcinoma of the prostate
- Eastern Co-Operative Oncology Group (ECOG) 0-2
- defined as clinical stage tumor cT1 or cT2a, International Society of Urological Pathology (ISUP) grade group 2-4 in less than or equal to 50% of the cores, unilateral extracapsular extension (ECE), prostate specific...
- corresponding to an Identified dominant intraprostatic lesion (DIL) on multiparametric magnetic resonance imaging (mpMRI) Prostate Imaging Reporting and Data System score (PI-RADs 3-5)
- Prostate volume less than or equal to 60 cc is recommended. Transrectal ultrasound (TRUS) and magnetic resonance imaging (MRI) are accepted to assess prostate volume.
- Contraindications to mpMRI
- Documented nodal or distant metastases
- Previous pelvic radiotherapy
- Recent transurethral resection of prostate (less than or equal to 6 months), previous prostatectomy or high-intensity focused ultrasound (HIFU)
- Poor baseline urinary function: International Prostate Symptom Score (IPSS) greater than 19
- Connective tissue disease or inflammatory bowel disease
- Patients deemed unsuitable for general anaesthetic by the Anaesthesia Department
- Patient is unable to lie flat long enough for the Radiation Therapy (RT) Simulation and Treatment
The study team makes the final eligibility decision.
Where it is enrolling
- London, Ontario, 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 London, Ontario, 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.