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2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-25 @ 11:49 PM
Study NCT ID:
NCT00776594
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2008-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Randomized Phase II Trial of Short-Course Androgen Deprivation Therapy +/- Bevacizumab for PSA Recurrence of Prostate Cancer After Definitive Local Therapy
Status:
COMPLETED
Status Verified Date:
2016-09
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:
None
Brief Summary:
The purpose of this research study is to assess the efficacy of antiangiogenic therapy (bevacizumab) and androgen deprivation versus androgen deprivation alone at the time of minimal systemic disease (based on rising PSA without metastases).
Detailed Description:
* Participants will be randomized into one of two study groups. The first group will receive Androgen Deprivation Therapy (ADT) plus bevacizumab. The second group will receive ADT alone.
* For the Androgen Deprivation therapy either (treating physician discretion)leuprolide or goserelin acetate (given as injections) every 3 months for a total of 6 months. Bicalutamide will also be taken orally daily for a total of 6 months.
* Bevacizumab will be given intravenously every three weeks for a total of 8 infusions over 6 months.
* Participants will be evaluated every 7-9 weeks with vitals, physical exam, PS, laboratories including PSA and testosterone.
* For the Androgen Deprivation therapy either (treating physician discretion)leuprolide or goserelin acetate (given as injections) every 3 months for a total of 6 months. Bicalutamide will also be taken orally daily for a total of 6 months.
* Bevacizumab will be given intravenously every three weeks for a total of 8 infusions over 6 months.
* Participants will be evaluated every 7-9 weeks with vitals, physical exam, PS, laboratories including PSA and testosterone.
Study Oversight
Has Oversight DMC:
True
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?: