Sandostatin for Patients With Androgen Independent Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00510224|
Recruitment Status : Terminated (Stopped at interim analyses phase due to lack of efficacy)
First Posted : August 1, 2007
Results First Posted : December 11, 2013
Last Update Posted : December 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Sandostatin||Phase 2|
To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Sandostatin 30mg intramuscular every 28 days
- PSA Response [ Time Frame: 12 weeks ]Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.
- Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1. [ Time Frame: Baseline, 12 weeks ]Serum was batched and IGF and IGFBP levels were assayed at one time at the end of the study using an enzyme-linked immunoabsorbent assay (ELISA) method by Diagnostic Systems Laboratories (Webster, TX).
- Grade 4-5 Adverse Events [ Time Frame: 12 weeks ]
- Pre Versus Post Treatment Mitogenic Effects. [ Time Frame: 12 Weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510224
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Charles Ryan, MD||University of California, San Francisco|