Electively Combining Two Ablative RadioTherapy Treatments for Favorable Risk Prostate Cancer Patients (EARTH)

Who is this study for? Adult patients with prostate cancer
What treatments are being studied? SABR+HDR brachytherapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Favorable-risk prostate cancer represent a large proportion of patients diagnosed with prostate cancer and image guided radiation therapy (IGRT) is commonly used to treat these patients using protracted courses of up to 39 treatments over 8 weeks. Stereotactic ablative body radiotherapy (SABR) protocols hold the promise of more convenience, less side effects, less cost and improved system capacity without sacrificing excellent cancer control rates. By the same token, prostate high-dose rate (HDR) brachytherapy boost has been shown to be superior to standard external beam radiation. While two HDR fractions appear to optimize patient convenience and outcomes while minimizing costs, we wanted to determine the tolerability of combining one MR-guided HDR treatment with one SABR treatment to further reduce HDR resource use while maintaining favourable treatment outcomes.

Eligibility
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:

• Histologically confirmed diagnosis of adenocarcinoma of the prostate

• Favorable risk disease defined as either:

‣ Low risk disease: T1-T2c, grade group 1, PSA \< 10 ng/ml or

⁃ Favorable intermediate risk disease: One of T2c, grade group 2, or PSA 10-20 ng/ml. Patients cannot have percent core positivity \> 50%

• Prostate volume \< 60 cc as determined by US, CT or MRI

• Ability to undergo MR imaging

• Provide written informed consent

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Merrylee McGuffin, MSc
Merrylee.Mcguffin@sunnybrook.ca
416-480-6100
Time Frame
Start Date: 2020-07-29
Estimated Completion Date: 2028-07-29
Participants
Target number of participants: 30
Treatments
Experimental: Intervention Arm
Related Therapeutic Areas
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov