Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309985
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2006-03-29
Brief Title:
Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
Sponsor:
ECOG-ACRIN Cancer Research Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
CHAARTED ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
CHAARTED
Brief Summary:
RATIONALE Androgens can cause the growth of prostate cancer cells Androgen ablation therapy may stop the adrenal glands from making androgens Drugs used in chemotherapy such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing It is not yet known whether androgen-ablation therapy is more effective with or without docetaxel in treating metastatic prostate cancer
PURPOSE This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer
PURPOSE This randomized phase III trial is studying androgen-ablation therapy and chemotherapy to see how well they work compared to androgen-ablation therapy alone in treating patients with metastatic prostate cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer
Secondary
Determine whether early chemotherapy can increase the time to clinical progression radiographic or symptomatic deterioration due to disease over hormonal therapy alone
Determine whether early chemotherapy can increase the time to development of hormone-refractory disease over hormonal therapy alone
Determine whether early chemotherapy can increase the time to serological progression over hormonal therapy alone
Determine rates of biochemical response at 6 months and 12 months in the chemohormonal arm versus the hormonal therapy alone arm
Determine the frequency of adverse events and the tolerability of chemotherapy combined with hormonal therapy versus hormonal therapy alone
Determine whether the postulated clinically meaningful increase in disease control is associated with an alteration in overall quality of life using the Functional Assessment of Cancer Therapy-Prostate questionnaire
Determine the ability of prostate-specific antigen PSA changes to be a surrogate for clinical benefit from therapy and overall survival
Tertiary
Determine whether there are proteins differentially translated from the genome in hormone-sensitive prostate cancer prostate cancer that has responded to hormonal therapy and hormone-refractory prostate cancer
Determine the frequency of constitutive polymorphisms of enzymes involved in steroid metabolism and other carcinogenic processes
Determine whether the amount and frequency of certain carcinogenic proteins in prostate cancer tissue such as C-X-C chemokine receptor type 4 CXCR-4 and manganese superoxide dismutase can be correlated with a poor prognosis
OUTLINE This is a randomized multicenter study Patients are stratified according to age 70 vs 70 ECOG performance status 0-1 vs 2 combined androgen blockade for 30 days yes vs no duration of prior adjuvant hormonal therapy 12 months vs 12 months concurrent bisphosphonate use yes vs no and volume of disease low vs high Patients are randomized to 1 of 2 treatment arms
Arm A Androgen-Deprivation Therapy and Docetaxel Patients receive androgen-deprivation therapy including luteinizing hormone-releasing hormone LHRH agonist therapy LHRH antagonist therapy or surgical castration Patients also receive docetaxel intravenously IV over 1 hour on day 1 Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm B Androgen-Deprivation Therapy alone Patients receive androgen-deprivation therapy as in arm A alone
Quality of life is assessed at baseline and at months 3 6 9 and 12
After completion of study treatment patients are followed up periodically for up to 10 years
Primary
Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer
Secondary
Determine whether early chemotherapy can increase the time to clinical progression radiographic or symptomatic deterioration due to disease over hormonal therapy alone
Determine whether early chemotherapy can increase the time to development of hormone-refractory disease over hormonal therapy alone
Determine whether early chemotherapy can increase the time to serological progression over hormonal therapy alone
Determine rates of biochemical response at 6 months and 12 months in the chemohormonal arm versus the hormonal therapy alone arm
Determine the frequency of adverse events and the tolerability of chemotherapy combined with hormonal therapy versus hormonal therapy alone
Determine whether the postulated clinically meaningful increase in disease control is associated with an alteration in overall quality of life using the Functional Assessment of Cancer Therapy-Prostate questionnaire
Determine the ability of prostate-specific antigen PSA changes to be a surrogate for clinical benefit from therapy and overall survival
Tertiary
Determine whether there are proteins differentially translated from the genome in hormone-sensitive prostate cancer prostate cancer that has responded to hormonal therapy and hormone-refractory prostate cancer
Determine the frequency of constitutive polymorphisms of enzymes involved in steroid metabolism and other carcinogenic processes
Determine whether the amount and frequency of certain carcinogenic proteins in prostate cancer tissue such as C-X-C chemokine receptor type 4 CXCR-4 and manganese superoxide dismutase can be correlated with a poor prognosis
OUTLINE This is a randomized multicenter study Patients are stratified according to age 70 vs 70 ECOG performance status 0-1 vs 2 combined androgen blockade for 30 days yes vs no duration of prior adjuvant hormonal therapy 12 months vs 12 months concurrent bisphosphonate use yes vs no and volume of disease low vs high Patients are randomized to 1 of 2 treatment arms
Arm A Androgen-Deprivation Therapy and Docetaxel Patients receive androgen-deprivation therapy including luteinizing hormone-releasing hormone LHRH agonist therapy LHRH antagonist therapy or surgical castration Patients also receive docetaxel intravenously IV over 1 hour on day 1 Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Arm B Androgen-Deprivation Therapy alone Patients receive androgen-deprivation therapy as in arm A alone
Quality of life is assessed at baseline and at months 3 6 9 and 12
After completion of study treatment patients are followed up periodically for up to 10 years
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 |
|---|---|---|---|
| U10CA180794 | NIH | ECOG-ACRIN Cancer Research Group | httpsreporternihgovquickSearchU10CA180794 |
| E3805 | OTHER | None | None |