Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06463457
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-11
Brief Title:
Comeback From Long coursE Androgen Deprivation Therapy ADT With RElugolix and Darolutamide CLEARED
Sponsor:
Atish Choudhury MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Comeback From Long coursE ADT With RElugolix and Darolutamide in Hormone-sensitive Prostate Cancer CLEARED
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 research study is being done to determine the rate of testosterone recovery after completing two years of treatment with the combination of relugolix and darolutamide as well as to assess the safety of the drugs when administered in combination
The names of the drugs in this study are
Relugolix a type of gonadotropin-releasing hormone receptor antagonist
Darolutamide a type of androgen receptor antagonist
The names of the drugs in this study are
Relugolix a type of gonadotropin-releasing hormone receptor antagonist
Darolutamide a type of androgen receptor antagonist
Detailed Description:
The aim of this single-arm phase 2 study is to assess testosterone recovery after completion of two years of combination treatment with relugolix and darolutamide and to describe safety tolerability and pharmacokinetics of relugolix and darolutamide when administered in combination Participants will select enrollment into one of two groups Group 1 or Group 2 The purpose of Group 1 is to determine the amount of each drug in the bloodstream after 2 hours 4 hours and 8 hours of treatment whereas the purpose of Group 2 is to determine the amount of each drug in the bloodstream after 1 day 7 days and 28 days of treatment
The US Food and Drug Administration FDA has approved relugolix for the treatment of advanced prostate cancer
The FDA has approved the combination of darolutamide with docetaxel for initial treatment of metastatic prostate cancer that is cancer that has spread to other parts of the body The FDA has also approved darolutamide alone for treatment of non-metastatic castration-resistant prostate cancer that is cancer that has become resistant to testosterone lowering medications without evidence of spread of the cancer to other parts of the body that can be detected on Computerized Tomography CT or bone scans
While darolutamide and relugolix can be prescribed together based on the FDA-approved indications of the individual drugs this combination has not been approved by the FDA or formally tested in clinical trials
The research study procedures include screening for eligibility study treatment visits questionnaires and blood tests Electrocardiograms EKGs will be performed if felt to be clinically indicated by the treating physician Imaging using a Computerized Tomography CT scan Magnetic Resonance Imaging MRI scan bone scan andor Prostate-Specific Membrane Antigen Positron Emission Tomography PSMA-PET scan is required before starting study treatment and will be performed after starting study treatment when felt to be clinically indicated by the treating physician
Participants will receive study treatment of relugolix and darolutamide for 2 years and will be followed for 18 months after the treatment period
It is expected that about 33 participants will take part in this research study
Bayer AG Pfizer and Sumitomo Pharma America SMPA Inc are funding this research study Bayer and SMPA are providing the study drugs darolutamide and relugolix respectively
The US Food and Drug Administration FDA has approved relugolix for the treatment of advanced prostate cancer
The FDA has approved the combination of darolutamide with docetaxel for initial treatment of metastatic prostate cancer that is cancer that has spread to other parts of the body The FDA has also approved darolutamide alone for treatment of non-metastatic castration-resistant prostate cancer that is cancer that has become resistant to testosterone lowering medications without evidence of spread of the cancer to other parts of the body that can be detected on Computerized Tomography CT or bone scans
While darolutamide and relugolix can be prescribed together based on the FDA-approved indications of the individual drugs this combination has not been approved by the FDA or formally tested in clinical trials
The research study procedures include screening for eligibility study treatment visits questionnaires and blood tests Electrocardiograms EKGs will be performed if felt to be clinically indicated by the treating physician Imaging using a Computerized Tomography CT scan Magnetic Resonance Imaging MRI scan bone scan andor Prostate-Specific Membrane Antigen Positron Emission Tomography PSMA-PET scan is required before starting study treatment and will be performed after starting study treatment when felt to be clinically indicated by the treating physician
Participants will receive study treatment of relugolix and darolutamide for 2 years and will be followed for 18 months after the treatment period
It is expected that about 33 participants will take part in this research study
Bayer AG Pfizer and Sumitomo Pharma America SMPA Inc are funding this research study Bayer and SMPA are providing the study drugs darolutamide and relugolix respectively
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?:
True
Is an FDA AA801 Violation?:
None