Radiation Therapy Alone, Radiation Therapy plus Leuprolide, or Radiation Therapy plus Relugolix for the Treatment of Non-metastatic Prostate Cancer

Active:	Yes
Cancer Type:	Prostate Cancer	NCT ID:	NCT05320406
Trial Phases:	Phase IV	Protocol IDs:	RAD5484-21 (primary) NCI-2022-00117 STUDY00003654
Eligibility:	18 Years and older, Male	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05320406

Summary

This phase 4 trial investigates the impact of prostate cancer treatment, specifically hormone therapy (leuprolide, relugolix), on the heart among patients with prostate cancer that has not spread to other parts of the body (non-metastatic). Recently, the effect of hormone therapy that is routinely used for prostate cancer on the heart has emerged as a concern, yet studies to identify who is at risk and how damage to the heart may occur are lacking. Additionally, a new hormone therapy drug, relugolix, has recently been Food and Drug Administration (FDA)-approved and may reduce toxicity to the heart. This trial may help researchers further investigate the impact of standard hormone therapy and relugolix (compared with no hormone therapy) on the heart.

Objectives

PRIMARY OBJECTIVES:
I. To identify and compare the association of gonadotrophin releasing hormone (GNRH)-agonist leuprolide acetate (leuprolide) versus GNRH-antagonist relugolix with accelerated coronary plaque development in men with prostate cancer.
II. Determine the relationship between GNRH-agonist versus relugolix with downstream immune effector response that is implicated in atherosclerosis.
IIa. To determine how proteomic biomarkers associated with inflammatory immunity correspond with cardiovascular (CV) toxicity following androgen deprivation therapy (ADT).
III. To determine how pre-existing genomic alterations promoting inflammatory immunity impact development of CV toxicity following GNRH-agonist (GNRHa) versus relugolix.

OUTLINE: Patients undergoing radiation therapy alone as part of their standard treatment are assigned to Arm I. Patients undergoing radiation therapy and hormone therapy as part of their standard treatment are randomized to Arm II or Arm III.

ARM I: Patients undergo radiation therapy for 12 months in the absence of disease progression or unacceptable toxicity.

ARM II (CLOSED TO ACCRUAL 09/05/2024): Patients undergo radiation therapy as in Arm I and receive leuprolide subcutaneously (SC) or intramuscularly (IM) and triptorelin pamoate (triptorelin) SC or IM every 3 or 6 months. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.

ARM III (CLOSED TO ACCRUAL 09/05/2024): Patients undergo radiation therapy as in Arm I and receive relugolix orally (PO) once daily (QD) for up to 12 months in the absence of disease progression or unacceptable toxicity.

Additionally, all patients undergo cardiac computerized tomographic angiography (CCTA) and blood sample collection throughout the study.

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