Prospective Trial of Combination External Beam Radiation Therapy and MRI-guided, Dose-differentiated High Dose-rate Prostate Brachytherapy Boost for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer

Who is this study for? Adult patients with prostate cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is trying to find out if the combination of Androgen deprivation therapy (ADT), MRI guided high dose radiation (HDR) brachytherapy treatment (internal radiation implant procedure) and external beam radiation therapy (EBRT) treatments lead to less side effects. This study is also looking at patient outcomes, quality of life, and overall survival for patients receiving this treatment.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Provision of signed and dated informed consent form.

• Stated willingness to comply with all study procedures and availability for the duration of the study.

• Male, aged 18 or above.

• Histologic proven diagnosis of cancer of the prostate up to one year before registration.

• Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019 (Section 12.4).

• History and physical exam completed up to 6 months before registration.

• PSA value \< 50 ng/mL prior to androgen deprivation therapy and up to 12 months before registration. Subjects who do not meet this criteria's timeframe due to extenuating circumstances (i.e. COVID-19 quarantine, changes to their treatment plan, etc) but meet all other eligibility criteria may still be eligible. The PI will review each case and decide

• ECOG performance status 0 or 1.

• Pelvic MRI obtained up to 12 months before registration.

⁃ Candidate for receiving the combination of HDR brachytherapy and EBRT, with or without ADT. The ADT may have begun prior to study enrollment.

Locations
United States
Virginia
University of Virginia
RECRUITING
Charlottesville
Contact Information
Primary
Song W
UVARADONCClinicalTrials@uvahealth.org
434-243-0008
Time Frame
Start Date: 2020-07-30
Estimated Completion Date: 2029-01-01
Participants
Target number of participants: 60
Treatments
Other: Treatment
Related Therapeutic Areas
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov