Ignite Creation Date:
2024-05-05 @ 10:04 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01023061
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2009-11-30
Brief Title:
Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Phase II Trial of Radiation With Androgen Deprivation Abiraterone Acetate Prednisone and Luteinizing Hormone Releasing Hormone Agonist Prior to Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2017-05
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:
RAD1
Brief Summary:
This phase II trial studies the side effects and how well abiraterone acetate prednisone and leuprolide acetate or goserelin before and during radiation therapy works in treating patients with localized or locally advanced prostate cancer Androgens can cause the growth of prostate cancer cells Antihormone therapy such as abiraterone acetate leuprolide acetate and goserelin may lessen the amount of androgens made by the body Radiation therapy uses high-energy x-rays to kill tumor cells Giving abiraterone acetate and leuprolide acetate or goserelin before or together with radiation therapy may be an effective treatment for prostate cancer
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety of abiraterone abiraterone acetate and prednisone with luteinizing hormone-releasing hormone agonist given as neoadjuvant and concurrent therapy with external beam radiation in patients with localized prostate cancer
II To determine whether pharmacologic suppression of the prostatic androgen axis by inhibition of androgen production with abiraterone can decrease tissue androgen levels to below those observed with gonadotropin-releasing hormone GnRH agonist suppression of testicular androgens
SECONDARY OBJECTIVES
I To determine whether treatment with abiraterone acetate with luteinizing releasing hormone agonist will be more effective than agonist with bicalutamide in inducing inhibition of androgen-regulated gene expression and increased apoptotic cell death as assessed by immunohistochemistry complementary deoxyribonucleic acid cDNA microarray analysis and reverse transcription-polymerase chain reaction RT-PCR
II To evaluate time to prostate-specific antigen progression in patients treated with GnRH agonist with abiraterone acetate
OUTLINE
Patients receive abiraterone acetate orally and prednisone once daily for 24 weeks Patients also receive leuprolide acetate or goserelin in weeks 1 and 13 Patients undergo external beam radiotherapy starting in week 15 for 85 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 5 years
I To evaluate the safety of abiraterone abiraterone acetate and prednisone with luteinizing hormone-releasing hormone agonist given as neoadjuvant and concurrent therapy with external beam radiation in patients with localized prostate cancer
II To determine whether pharmacologic suppression of the prostatic androgen axis by inhibition of androgen production with abiraterone can decrease tissue androgen levels to below those observed with gonadotropin-releasing hormone GnRH agonist suppression of testicular androgens
SECONDARY OBJECTIVES
I To determine whether treatment with abiraterone acetate with luteinizing releasing hormone agonist will be more effective than agonist with bicalutamide in inducing inhibition of androgen-regulated gene expression and increased apoptotic cell death as assessed by immunohistochemistry complementary deoxyribonucleic acid cDNA microarray analysis and reverse transcription-polymerase chain reaction RT-PCR
II To evaluate time to prostate-specific antigen progression in patients treated with GnRH agonist with abiraterone acetate
OUTLINE
Patients receive abiraterone acetate orally and prednisone once daily for 24 weeks Patients also receive leuprolide acetate or goserelin in weeks 1 and 13 Patients undergo external beam radiotherapy starting in week 15 for 85 weeks Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 5 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 |
|---|---|---|---|
| P30CA015704 | NIH | Fred Hutchinson Cancer Research CenterUniversity of Washington Cancer Consortium | httpsreporternihgovquickSearchP30CA015704 |
| NCI-2009-01346 | REGISTRY | None | None |
| 7048 - AbiRAD | None | None | None |
| 7048 | OTHER | None | None |