Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06129851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-11-03
Brief Title:
Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Quantifying Optimal Relugolix Duration With Radiation in High Risk Prostate Cancer QURE-PC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
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 evaluates the best duration for relugolix to be given in combination with radiation therapy when treating patients with high risk prostate cancer Prostate cancer is a hormonal influenced cancer Part of the usual treatment for patients with prostate cancer is androgen deprivation therapy ADT ADT is used to lower the amount of testosterone in the body because testosterone appears to help prostate cancer grow Relugolix works to reduce testosterone levels which may inhibit proliferation of prostate cancer cells It is approved by the Food and Drug Administration to treat prostate cancer Adding relugolix to standard radiation therapy might work better and have fewer side effects than prior forms of hormonal therapy but the optimal duration of relugolix in combination with radiation is not known
Detailed Description:
PRIMARY OBJECTIVE
I To compare the biochemical recurrence rate between 12 and 24 months of relugolix in patients with high risk prostate cancer treated with combination external beam radiation and brachytherapy
SECONDARY OBJECTIVES
I To compare the composite quality of life in patient treated with 12 months and 24 months of relugolix as assessed by the Expanded Prostate Composite Index Short Form EPIC-26 instrument
II To compare the treatment related toxicity between 12 months and 24 months of relugolix as assessed by Common Terminology Criteria for Adverse Events version 50 CTCAE v 50 criteria
III To compare the rate of major adverse cardiovascular events MACE in patients treated with 12 and 24 months of relugolix
IV To establish the rate of patient compliance using patient reported drug diary
V To compare the rate of testosterone recovery after 12 and 24 months of relugolix
EXPLORATORY OBJECTIVE
I To establish Decipher genomic classifier as predictor of cancer control
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive relugolix orally PO once daily QD Cycles repeat every 3 months for 12 months in the absence of disease progression or unacceptable toxicity Beginning 30 to 180 days after start of relugolix patients undergo brachytherapy and external beam radiation over 25 fractions Patients undergo bone scan computed tomography CT or magnetic resonance imaging MRI or prostate-specific membrane antigen PSMA positron emission tomography PET scan during screening Patients also undergo dual x-ray absorptiometry DEXA scan and may optionally undergo blood sample collection throughout the trial
ARM B Patients receive relugolix PO QD Cycles repeat every 3 months for 24 months in the absence of disease progression or unacceptable toxicity Beginning 30 to 180 days after start of relugolix patients undergo brachytherapy and external beam radiation over 25 fractions Patients undergo bone scan CT or MRI or PSMA PET scan during screening Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial
After completion of study treatment patients in Arm A are followed up every 3 months for 12 months and then every 6 months for up to 36 months and patients in Arm B are followed up every 6 months for up 36 months
I To compare the biochemical recurrence rate between 12 and 24 months of relugolix in patients with high risk prostate cancer treated with combination external beam radiation and brachytherapy
SECONDARY OBJECTIVES
I To compare the composite quality of life in patient treated with 12 months and 24 months of relugolix as assessed by the Expanded Prostate Composite Index Short Form EPIC-26 instrument
II To compare the treatment related toxicity between 12 months and 24 months of relugolix as assessed by Common Terminology Criteria for Adverse Events version 50 CTCAE v 50 criteria
III To compare the rate of major adverse cardiovascular events MACE in patients treated with 12 and 24 months of relugolix
IV To establish the rate of patient compliance using patient reported drug diary
V To compare the rate of testosterone recovery after 12 and 24 months of relugolix
EXPLORATORY OBJECTIVE
I To establish Decipher genomic classifier as predictor of cancer control
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients receive relugolix orally PO once daily QD Cycles repeat every 3 months for 12 months in the absence of disease progression or unacceptable toxicity Beginning 30 to 180 days after start of relugolix patients undergo brachytherapy and external beam radiation over 25 fractions Patients undergo bone scan computed tomography CT or magnetic resonance imaging MRI or prostate-specific membrane antigen PSMA positron emission tomography PET scan during screening Patients also undergo dual x-ray absorptiometry DEXA scan and may optionally undergo blood sample collection throughout the trial
ARM B Patients receive relugolix PO QD Cycles repeat every 3 months for 24 months in the absence of disease progression or unacceptable toxicity Beginning 30 to 180 days after start of relugolix patients undergo brachytherapy and external beam radiation over 25 fractions Patients undergo bone scan CT or MRI or PSMA PET scan during screening Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial
After completion of study treatment patients in Arm A are followed up every 3 months for 12 months and then every 6 months for up to 36 months and patients in Arm B are followed up every 6 months for up 36 months
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 |
|---|---|---|---|
| P30CA168524 | NIH | University of Kansas Cancer Center | httpsreporternihgovquickSearchP30CA168524 |
| NCI-2023-09079 | REGISTRY | None | None |
| STUDY00150674 | OTHER | None | None |