Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04248621
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2020-01-15
Brief Title:
Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients
Sponsor:
Wonju Severance Christian Hospital
Organization:
Wonju Severance Christian Hospital
Study Overview
Official Title:
The Impact of Continuous Versus Intermittent Androgen Deprivation Therapy on Bone Mineral Density Change in Prostate Cancer Patients A Multicenter Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
RECRUITING
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:
Androgen deprivation therapy ADT is a mainstay of prostate cancer treatment to improve overall survival for intermediate- and high-risk localized disease as well as metastatic disease While ADT improves survival it can cause significant morbidity and a decrement in quality of life In particular ADT is associated with decrease in bone mineral density BMD and increased risk of fracture
Although current guidelines recommend continuous androgen deprivation therapy CAD as standard therapy for high-risk disease there has been increasing recognition of adverse effects from CAD Since 1986 intermittent androgen deprivation therapy IAD as alternative therapeutic strategy for prostate cancer has been proposed to delay development of castration resistance and to reduce the side effects of ADT
While both CAD and IAD are commonly used in real clinical practice no prior study examined BMD change after CAD or IAD and assessed whether bone loss would recover during off-treatment of IAD The investigators therefore determine the rate of change in BMD induced by ADT CAD versus IAD in men with prostate cancer
Although current guidelines recommend continuous androgen deprivation therapy CAD as standard therapy for high-risk disease there has been increasing recognition of adverse effects from CAD Since 1986 intermittent androgen deprivation therapy IAD as alternative therapeutic strategy for prostate cancer has been proposed to delay development of castration resistance and to reduce the side effects of ADT
While both CAD and IAD are commonly used in real clinical practice no prior study examined BMD change after CAD or IAD and assessed whether bone loss would recover during off-treatment of IAD The investigators therefore determine the rate of change in BMD induced by ADT CAD versus IAD in men with prostate cancer
Detailed Description:
Objective To determine the rate of bone mass loss induced by two therapeutic strategies of ADT CAD versus IAD in men with prostate cancer
Design setting and participants the investigators will perform randomized open label clinical trial Men aged over 50 yrs old with prostate cancer localized locally advanced metastatic prostate cancer who are treated with primary ADT for newly diagnosed prostate cancer or salvage ADT at biochemical recurrence following radical prostatectomy will be included
Participants will be randomly assigned to one of the following treatment arms
Arm 1 CAD ADT without any discontinuation during study period 12 months
Arm 2 IAD ADT for the first 6 months of study period if the prostate-specific antigen PSA reaches its nadir 4 ngdL and serum testosterone reaches castration level 50 ngdL
Outcomes
Primary outcome change of L-spine total BMD Secondary outcomes change of femur neck BMD incidence rate of osteoporosis risk of 10 year major osteoporotic fracture quality of life based on Expanded Prostate Cancer Index EPIC questionnaire
Timing of outcome measurement at baseline and up to 12 months after randomization
Statistical analyses students t test for continuous outcomes and Fishers exact or chi-square test for dichotomous outcomes
Design setting and participants the investigators will perform randomized open label clinical trial Men aged over 50 yrs old with prostate cancer localized locally advanced metastatic prostate cancer who are treated with primary ADT for newly diagnosed prostate cancer or salvage ADT at biochemical recurrence following radical prostatectomy will be included
Participants will be randomly assigned to one of the following treatment arms
Arm 1 CAD ADT without any discontinuation during study period 12 months
Arm 2 IAD ADT for the first 6 months of study period if the prostate-specific antigen PSA reaches its nadir 4 ngdL and serum testosterone reaches castration level 50 ngdL
Outcomes
Primary outcome change of L-spine total BMD Secondary outcomes change of femur neck BMD incidence rate of osteoporosis risk of 10 year major osteoporotic fracture quality of life based on Expanded Prostate Cancer Index EPIC questionnaire
Timing of outcome measurement at baseline and up to 12 months after randomization
Statistical analyses students t test for continuous outcomes and Fishers exact or chi-square test for dichotomous outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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