Pilot Study to Identify Radiogenomic Biomarkers to Predict Early Treatment Response to Androgen Deprivation Therapy and Radiation Therapy in High Risk Prostate Cancer

NCT05477823 EARLY_PHASE1 ACTIVE_NOT_RECRUITING

The purpose of this study is to evaluate the imaging and gene expression biomarkers in prostate cancer. Participants have high-risk prostate cancer and have indicated they will undergo external beam radiation therapy, brachytherapy, and androgen deprivation therapy (EBRT+BTX+ADT). Participants can expect to be in this study for up to 5 years.

Details

Lead sponsor	University of Wisconsin, Madison
Phase	EARLY_PHASE1
Status	ACTIVE_NOT_RECRUITING
Enrolment	30
Start date	2023-03-08
Completion	2027-08

Conditions

• Prostate Cancer

Interventions

• External beam radiation therapy
• Prostate brachytherapy boost
• Androgen deprivation therapy
• Positron emission tomography (PET)/magnetic resonance imaging (MRI)

Primary outcomes

• Imaging markers for mid-treatment response — Mid-treatment (approximately 3 months into treatment)
  Evaluate prostate specific membrane antigen (PSMA) PET/MRI for imaging biomarkers that predict mid-treatment response to ADT and EBRT to identify participants at risk for poor response to radiation therapy and ADT.

Countries

United States