Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510224
Status:
TERMINATED
Last Update Posted:
2013-12-11
First Post:
2007-07-30
Brief Title:
Sandostatin for Patients With Androgen Independent Prostate Cancer
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Stopped at interim analyses phase due to lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label single center Phase II trial of Sandostatin LAR in patients with hormone refractory prostate cancer Patients will receive Sandostatin LAR 30 mg intramuscularly every 28 days Patients will be treated until the time of disease progression unacceptable toxicity or withdrawal of consent The study will require 27 evaluable patients
Detailed Description:
Primary Objective
To evaluate changes in prostate specific antigen PSA in patients with androgen independent prostate cancer who are treated with Sandostatin LAR
Secondary Objective
To evaluate the effects of Sandostatin LAR on circulating levels of Insulin Growth Factor-1 and Insulin Growth Factor Binding Protein 1
To evaluate the safety of Sandostatin LAR in this patient population To evaluate the pre versus post treatment mitogenic effects of serum derived from subjects with prostate cancer compared to pretreatment serum
Patients with androgen independent prostate cancer who do not have bone or visceral metastases are selected for this trial because they are a patient population that is likely to have no symptoms from the disease or rapid progression that would suggest the need for chemotherapy Additionally given the preclinical data suggesting that IGF-1 expression and signaling occurs concomitantly with the onset of androgen independent growth it is felt that testing in the early androgen independent state is warranted This trial is consistent with overall goal to develop IGF-1 targeted therapies in patients with disease progression and a lower disease burden
To evaluate changes in prostate specific antigen PSA in patients with androgen independent prostate cancer who are treated with Sandostatin LAR
Secondary Objective
To evaluate the effects of Sandostatin LAR on circulating levels of Insulin Growth Factor-1 and Insulin Growth Factor Binding Protein 1
To evaluate the safety of Sandostatin LAR in this patient population To evaluate the pre versus post treatment mitogenic effects of serum derived from subjects with prostate cancer compared to pretreatment serum
Patients with androgen independent prostate cancer who do not have bone or visceral metastases are selected for this trial because they are a patient population that is likely to have no symptoms from the disease or rapid progression that would suggest the need for chemotherapy Additionally given the preclinical data suggesting that IGF-1 expression and signaling occurs concomitantly with the onset of androgen independent growth it is felt that testing in the early androgen independent state is warranted This trial is consistent with overall goal to develop IGF-1 targeted therapies in patients with disease progression and a lower disease burden
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