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Compares treatment options for Prostate Cancer
Official title Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer
ClinicalTrials.gov ID: NCT05600400
What this study is testing
- What it's testing
- Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions.
- 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 prostate adenocarcinoma (centrally reviewed)
- Low or favorable intermediate risk disease. Patient must meet one of the following categories:
- Low risk - T1-T2b, grade group 1, AND PSA \< 10 ng/ml;
- Favorable risk
- Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or
You likely can't join if
- Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Large prostate (\>90cm3) on imaging
- Immunosuppressive medications
See the full eligibility criteria
- Histologically confirmed prostate adenocarcinoma (centrally reviewed)
- Low or favorable intermediate risk disease. Patient must meet one of the following categories:
- Low risk - T1-T2b, grade group 1, AND PSA \< 10 ng/ml;
- Favorable risk
- Only one of the following intermediate risk factors - cT2c, grade group 2, or PSA 10-20 ng/ml; or
- Grade group 3 AND PSA \< 20, AND \<cT2c AND absolute percentage pattern 4/5 is \<10%
- Androgen deprivation therapy (LHRH-agonists or antiandrogens) given or planned
- Prior pelvic radiotherapy
- Anticoagulation medication (if unsafe to discontinue for gold seed insertion)
- Diagnosis of bleeding diathesis
- Large prostate (\>90cm3) on imaging
- Immunosuppressive medications
- Inflammatory bowel disease
- Presence of dual hip prostheses
- Contraindications to having MRI
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, 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 - 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?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.