Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06499870
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer OPTIMAL Trial
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Optimizing Treatment and Advanced Multi-Imaging Response Evaluation for Very-High-Risk Prostate Cancer OPTIMAL - a Phase II Single Arm Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial tests how well relugolix and enzalutamide in combination with radiation therapy works in treating patients with very high risk prostate cancer Relugolix is a form of androgen deprivation therapy It prevents the release of testosterone a hormone required to sustain prostate growth Reducing testosterone levels may inhibit the proliferation of prostate tumor cells that need testosterone to grow Enzalutamide is an androgen receptor signaling inhibitor It inhibits the activity of prostate tumor cell receptors which may reduce proliferation of prostate tumor cells Radiation therapy uses high energy x-rays particles or radioactive seeds to kill cancer cells and shrink tumors Adding relugolix and enzalutamide to radiation therapy may be more effective at treating patients with very high risk prostate cancer than giving any of these treatments alone
Detailed Description:
PRIMARY OBJECTIVE
I To determine the efficacy of radiation therapy RT with androgen deprivation therapy ADT relugolix and an androgen receptor signaling inhibitor enzalutamide for a total duration of 18 months in patients with National Comprehensive Cancer Network NCCN very high-risk prostate cancer as determined by a 2-year biopsy positivity rate
SECONDARY OBJECTIVES
I To determine the 4-year disease free survival DFS biochemical failure of prostate specific antigen PSA nadir 2ngmL local or regional recurrence distant metastasis or death from any cause
II To evaluate testosterone recovery
EXPLORATORY OBJECTIVES
I To evaluate impact on patient-reported health-related quality of life utilizing 1 Expanded Prostate Cancer Index Composite EPIC-26 and 2 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 EORTC QLC-C30
II To investigate a relationship between magnetic resonance imaging MRI-positron emission tomography PET radiomic response baseline and after neoadjuvant therapy correlated with pathologic and disease control endpoints
OUTLINE
Patients receive relugolix orally PO once daily QD and enzalutamide PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 18 months in the absence of disease progression or unacceptable toxicity After 4 months of treatment with relugolix and enzalutamide patients begin image-guided radiation therapy IGRT per standard of care Patients also undergo fluorine F 18 piflufolastat PETMRI and CT on the trial undergo collection of blood samples throughout the trial and undergo biopsy during follow up
After completion of study treatment patients are followed up every 3-6 months for up to 30 months 48 months after study registration
I To determine the efficacy of radiation therapy RT with androgen deprivation therapy ADT relugolix and an androgen receptor signaling inhibitor enzalutamide for a total duration of 18 months in patients with National Comprehensive Cancer Network NCCN very high-risk prostate cancer as determined by a 2-year biopsy positivity rate
SECONDARY OBJECTIVES
I To determine the 4-year disease free survival DFS biochemical failure of prostate specific antigen PSA nadir 2ngmL local or regional recurrence distant metastasis or death from any cause
II To evaluate testosterone recovery
EXPLORATORY OBJECTIVES
I To evaluate impact on patient-reported health-related quality of life utilizing 1 Expanded Prostate Cancer Index Composite EPIC-26 and 2 European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 EORTC QLC-C30
II To investigate a relationship between magnetic resonance imaging MRI-positron emission tomography PET radiomic response baseline and after neoadjuvant therapy correlated with pathologic and disease control endpoints
OUTLINE
Patients receive relugolix orally PO once daily QD and enzalutamide PO QD on days 1-28 of each cycle Cycles repeat every 28 days for up to 18 months in the absence of disease progression or unacceptable toxicity After 4 months of treatment with relugolix and enzalutamide patients begin image-guided radiation therapy IGRT per standard of care Patients also undergo fluorine F 18 piflufolastat PETMRI and CT on the trial undergo collection of blood samples throughout the trial and undergo biopsy during follow up
After completion of study treatment patients are followed up every 3-6 months for up to 30 months 48 months after study registration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03934 | REGISTRY | None | None |
| STU00221219 | None | None | None |
| NU 24U02 | OTHER | None | None |
| P30CA060553 | NIH | None | None |