Risk Stratified De-Escalated De-Intensified Treatment for High Risk Prostate Cancer Patients Based on Pathologic Criteria, Genetic Score, and Biologic Imaging
Mayo Clinic
Summary
This phase II trial tests how well risk based de-escalated hormone therapy (i.e., fewer treatments) with radiation works in treating patients with prostate cancer. Androgen deprivation therapy (ADT), such as gonadotropin-releasing hormone analogs (LHRH) and abiraterone acetate (Zytiga), lower the amount of the male hormone, testosterone, made by the body. This may help kill or stop the growth of tumor cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Research has shown that long-term ADT is beneficial for patients with high-risk prostate cancer. However, there are few studies that determine ADT treatment based on risk factors. Giving risk based de-escalated ADT with radiation therapy may be as effective as giving more ADT in treating high-risk prostate cancer.
Description
PRIMARY OBJECTIVE: I. Recovery of the Expanded Prostate Cancer Index Composite (EPIC) hormonal domain to baseline levels at 2-years. EXPLORATORY OBJECTIVES: I. After completion of radiation therapy, determine the incidence of: Ia. Grade 2 or greater genitourinary (GU) and gastrointestinal (GI) toxicity at 6 months (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0); Ib. Grade 3 or greater GU and GI toxicity at 6 months (CTCAE version 5.0); Ic. Patient-reported quality of life; Id. Impotence after the use of radiation therapy at 3 years; Ie. Freedom from biochemical failu…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically confirmed high risk prostate adenocarcinoma * Pathologic stages T1c-T4, N0-Nx-N1, M0-1 as staged by the pathology report (AJCC Criteria 8th Edition \[Ed\].) * One or more high risk features including Gleason 8-10, T3-T4, prostate specific antigen (PSA) ≥ 20 * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Patients must sign institutional review board (IRB) approved study specific informed consent * Patients must complete all required pre-entry tests * Patients must be at least 18 years old * Oligometastatic prostate cancer defined as di…
Interventions
- DrugAbiraterone Acetate
Given abiraterone acetate
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureComputed Tomography
Undergo CT
- BiologicalGonadotropin-releasing Hormone Analog
Given SC or IM
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography
Undergo PET
- OtherQuestionnaire Administration
Location
- Mayo Clinic in ArizonaScottsdale, Arizona