Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06274047
Status:
RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-02-16
Brief Title:
PROSTATE-IQ Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation with Androgen Axis Suppression a Phase III Multi-center Study for Men with Detectable PSA After Prostatectomy for Prostate Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
PROSTATE-IQ Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation with Androgen Axis Suppression a Phase III Multi-center Study for Men with Detectable PSA After Prostatectomy for Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Personalize treatment for prostate cancer based on how aggressive the disease is and
2 Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer as compared to standard therapy
2 Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer as compared to standard therapy
Detailed Description:
Primary Objective
ARTERA LOW COHORT less aggressive disease
1 To compare fatigue at 9 months as assessed by FACIT-F between participants assigned to six months of apalutamide monotherapy versus six months of GnRH-based ADT
HIGHER RISK COHORT more aggressive disease
1 To compare fatigue at 24 months as assessed by FACIT-fatigue between participants assigned to six months of GnRH-based ADT plus apalutamide monotherapy versus 24 months of GnRH-based ADT
Secondary Objectives for both Cohorts
1 To compare patient-reported quality of life for the two treatment arms Arm 1 vs 2 for Artera-Low Cohort and Arm 3 vs 4 for Artera-High Cohort as measured by FACT-P and EPIC-26
2 To compare physician-reported toxicity for the two treatment arms as measured by CTCAE v 5
3 To compare patient-reported activity levels for the two treatment arms as measured by the leisure-time activity questionnaire
4 To compare patient activity and sleep for the two treatment arms as measured by participant wearable health bands
5 To compare cognitive function for the two treatment arms as measured by PROMIS-CF and the Symbol Digit Modality test
6 To compare mental health for the two treatment arms as measured by the Health Anxiety and Depression Scale
7 To compare changes in HgA1c and Lipid profiles over time between the two treatment arms
8 To compare time to testosterone recovery between treatment arms
9 To compare time to next therapy between treatment arms
10 To compare progression-free survival metastasis-free survival cancer specific mortality and overall survival between treatment arms
11 To compare risk of major acute coronary event between treatment arms
12 In the subset of patients who agree to optional body composition measurements to compare change in body composition including visceral fat and skeletal muscle mass between treatment arms
Exploratory Objectives for both Cohorts
1 In the subset of participants who agree to correlative studies to evaluate the association between fatigue and circulating inflammatory cytokines
2 In the subset of participants who agree to germline testing to determine if inherited variants in steroidogenic genes influence individual body composition toxicity with androgen signaling inhibition
3 To evaluate how germline variants interact with tumor intrinsic properties via Artera to determine the overall benefit patients derive from finite intense androgen signaling inhibition in the post-operative setting
4 To investigate the relationship between plasma exosomes Artera tissue pattern and the germline to somatic interaction
5 To study the overlap between body composition toxicity and risk for coronary artery disease as measured by radiographic coronary calcifications and lab markers of coronary artery disease
6 To evaluate the association between radiation plan metrics and patient-reported urinary and bowel functional changes
ARTERA LOW COHORT less aggressive disease
1 To compare fatigue at 9 months as assessed by FACIT-F between participants assigned to six months of apalutamide monotherapy versus six months of GnRH-based ADT
HIGHER RISK COHORT more aggressive disease
1 To compare fatigue at 24 months as assessed by FACIT-fatigue between participants assigned to six months of GnRH-based ADT plus apalutamide monotherapy versus 24 months of GnRH-based ADT
Secondary Objectives for both Cohorts
1 To compare patient-reported quality of life for the two treatment arms Arm 1 vs 2 for Artera-Low Cohort and Arm 3 vs 4 for Artera-High Cohort as measured by FACT-P and EPIC-26
2 To compare physician-reported toxicity for the two treatment arms as measured by CTCAE v 5
3 To compare patient-reported activity levels for the two treatment arms as measured by the leisure-time activity questionnaire
4 To compare patient activity and sleep for the two treatment arms as measured by participant wearable health bands
5 To compare cognitive function for the two treatment arms as measured by PROMIS-CF and the Symbol Digit Modality test
6 To compare mental health for the two treatment arms as measured by the Health Anxiety and Depression Scale
7 To compare changes in HgA1c and Lipid profiles over time between the two treatment arms
8 To compare time to testosterone recovery between treatment arms
9 To compare time to next therapy between treatment arms
10 To compare progression-free survival metastasis-free survival cancer specific mortality and overall survival between treatment arms
11 To compare risk of major acute coronary event between treatment arms
12 In the subset of patients who agree to optional body composition measurements to compare change in body composition including visceral fat and skeletal muscle mass between treatment arms
Exploratory Objectives for both Cohorts
1 In the subset of participants who agree to correlative studies to evaluate the association between fatigue and circulating inflammatory cytokines
2 In the subset of participants who agree to germline testing to determine if inherited variants in steroidogenic genes influence individual body composition toxicity with androgen signaling inhibition
3 To evaluate how germline variants interact with tumor intrinsic properties via Artera to determine the overall benefit patients derive from finite intense androgen signaling inhibition in the post-operative setting
4 To investigate the relationship between plasma exosomes Artera tissue pattern and the germline to somatic interaction
5 To study the overlap between body composition toxicity and risk for coronary artery disease as measured by radiographic coronary calcifications and lab markers of coronary artery disease
6 To evaluate the association between radiation plan metrics and patient-reported urinary and bowel functional changes
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-01553 | OTHER | NCI-CTRP Clinical Registry | None |