Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228124
Status:
UNKNOWN
Last Update Posted:
2006-01-26
First Post:
2005-09-27
Brief Title:
PR7 Companion Trial Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition
Sponsor:
Ontario Cancer Research Network
Organization:
Ontario Cancer Research Network
Study Overview
Official Title:
Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition in a Phase III Randomized Trial
Status:
UNKNOWN
Status Verified Date:
2005-09
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:
The purpose of this study is to determine in patients entered on the National Cancer Institute of Canada NCIC-PR7 trial of intermittent versus continuous androgen ablation whether the rates of osteoporosis fractures and alteration in body composition are reduced by intermittent androgen ablation
There will be two groups of patients
1 A cross-sectional group of 150 patients registered in PR7 prior to January 1 2002 randomized between intermittent androgen suppression IAS and continuous androgen suppression CAS 75 from each group Patients who have definite bone metastases are excluded from this study Biochemical failure does not exclude the patient
2 A longitudinal study of 150 newly accrued patients randomized between IAS and CAS 75 from each group These patients will have baseline evaluation of bone loss and body composition longitudinal monitoring and follow-up on an annual basis for patients on CAS and at the end of each off cycle of IAS Patients taking bisphosphonates are excluded from this study
There will be two groups of patients
1 A cross-sectional group of 150 patients registered in PR7 prior to January 1 2002 randomized between intermittent androgen suppression IAS and continuous androgen suppression CAS 75 from each group Patients who have definite bone metastases are excluded from this study Biochemical failure does not exclude the patient
2 A longitudinal study of 150 newly accrued patients randomized between IAS and CAS 75 from each group These patients will have baseline evaluation of bone loss and body composition longitudinal monitoring and follow-up on an annual basis for patients on CAS and at the end of each off cycle of IAS Patients taking bisphosphonates are excluded from this study
Detailed Description:
Primary Objectives
1 To compare CAS and IAS with respect to bone mineral density BMD We will determine whether the bone loss associated with long term CAS can be reduced by IAS by evaluation of
1 BMD
2 biochemical markers of bone formationresorption
3 skeletal relevant events SRE defined as pathological fracture symptomatic hypercalcemia or hypocalcemia spinal cord compression or need of spinal orthosis for vertebral deformity or collapse
2 To compare CAS and IAS with respect to body composition We will determine whether the reduction in muscle mass and increased fat accumulation associated with long term CAS can be reduced by IAS We will evaluate
1 percentage fat body mass
2 percentage lean body mass and
3 body mass index
3 To evaluate the predictive value of germline polymorphisms in the Vitamin D receptor VDR gene for bone loss
Eligible Patients for PR7
1 Histologically confirmed prostate cancer PCa
2 Completed radiotherapy to the prostatic area more than 12 months prior to randomization
3 Rising prostate specific antigen PSA level serum PSA 3 ngml 3 μgL and higher than the lowest level recorded previously since the end of radiotherapy ie higher than the post-radiotherapy nadir
4 No definite evidence of distant metastasis radiological changes compatible with non-malignant diseases are acceptable
5 No prior hormonal therapy with the exception of neo-adjuvant cytoreduction prior to radical radiotherapy or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization
Evaluation during protocol treatment will take place to assess differences in BMD body composition biochemical and genetic markers of bone disease in the two groups
1 To compare CAS and IAS with respect to bone mineral density BMD We will determine whether the bone loss associated with long term CAS can be reduced by IAS by evaluation of
1 BMD
2 biochemical markers of bone formationresorption
3 skeletal relevant events SRE defined as pathological fracture symptomatic hypercalcemia or hypocalcemia spinal cord compression or need of spinal orthosis for vertebral deformity or collapse
2 To compare CAS and IAS with respect to body composition We will determine whether the reduction in muscle mass and increased fat accumulation associated with long term CAS can be reduced by IAS We will evaluate
1 percentage fat body mass
2 percentage lean body mass and
3 body mass index
3 To evaluate the predictive value of germline polymorphisms in the Vitamin D receptor VDR gene for bone loss
Eligible Patients for PR7
1 Histologically confirmed prostate cancer PCa
2 Completed radiotherapy to the prostatic area more than 12 months prior to randomization
3 Rising prostate specific antigen PSA level serum PSA 3 ngml 3 μgL and higher than the lowest level recorded previously since the end of radiotherapy ie higher than the post-radiotherapy nadir
4 No definite evidence of distant metastasis radiological changes compatible with non-malignant diseases are acceptable
5 No prior hormonal therapy with the exception of neo-adjuvant cytoreduction prior to radical radiotherapy or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization
Evaluation during protocol treatment will take place to assess differences in BMD body composition biochemical and genetic markers of bone disease in the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 02-OCT-0203 | None | None | None |