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Sandostatin for Patients With Androgen Independent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sandostatin
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate.
  • Biochemical disease progression following androgen deprivation and therapy with at least one antiandrogen defined as three rises in PSA with PSA determinations at least 4 weeks apart and each PSA value > 0.2 ng/ml.
  • Four weeks since prior therapy with Flutamide.
  • Six weeks since prior therapy with Bicalutamide or Nilutamide.
  • Current PSA > 5 ng/ml.
  • Testosterone <50 ng/dL.
  • SGPT (ALT) < 1.5 times upper limit of normal.
  • Fasting blood glucose > 60 mg/dL.
  • ECOG performance status 0, 1 or 2.
  • No visceral or bony metastatic disease (Lymph node only metastases are allowed).
  • No prior chemotherapy for prostate cancer.
  • No current treatment with insulin or an oral hypoglycemic.
  • No history of treatment with octreotide analogs for prostate cancer.
  • No NYHA Class 3 or 4 cardiac status.

Exclusion Criteria:

  • Diabetes Mellitus requiring medical therapy and/or that which is not controlled by dietary means (HbA1C<6.0).
  • A history of gallstones that has been clinically significant. Patients who have undergone cholecystectomy are eligible.
  • Other concomitant medical or psychiatric condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements.
  • Prior treatment with chemotherapy for prostate cancer.
  • No current treatment with Saw Palmetto, or Proscar. Patients must be off these medicines for more than 4 weeks.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

PSA Response
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.

Secondary Outcome Measures

Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.
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
Pre Versus Post Treatment Mitogenic Effects.

Full Information

First Posted
July 30, 2007
Last Updated
October 17, 2013
Sponsor
University of California, San Francisco
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00510224
Brief Title
Sandostatin for Patients With Androgen Independent Prostate Cancer
Official Title
A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Stopped at interim analyses phase due to lack of efficacy
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sandostatin
Intervention Description
Sandostatin 30mg intramuscular every 28 days
Primary Outcome Measure Information:
Title
PSA Response
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.
Description
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).
Time Frame
Baseline, 12 weeks
Title
Grade 4-5 Adverse Events
Time Frame
12 weeks
Title
Pre Versus Post Treatment Mitogenic Effects.
Time Frame
12 Weeks

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate. Biochemical disease progression following androgen deprivation and therapy with at least one antiandrogen defined as three rises in PSA with PSA determinations at least 4 weeks apart and each PSA value > 0.2 ng/ml. Four weeks since prior therapy with Flutamide. Six weeks since prior therapy with Bicalutamide or Nilutamide. Current PSA > 5 ng/ml. Testosterone <50 ng/dL. SGPT (ALT) < 1.5 times upper limit of normal. Fasting blood glucose > 60 mg/dL. ECOG performance status 0, 1 or 2. No visceral or bony metastatic disease (Lymph node only metastases are allowed). No prior chemotherapy for prostate cancer. No current treatment with insulin or an oral hypoglycemic. No history of treatment with octreotide analogs for prostate cancer. No NYHA Class 3 or 4 cardiac status. Exclusion Criteria: Diabetes Mellitus requiring medical therapy and/or that which is not controlled by dietary means (HbA1C<6.0). A history of gallstones that has been clinically significant. Patients who have undergone cholecystectomy are eligible. Other concomitant medical or psychiatric condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements. Prior treatment with chemotherapy for prostate cancer. No current treatment with Saw Palmetto, or Proscar. Patients must be off these medicines for more than 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Ryan, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20884247
Citation
Friedlander TW, Weinberg VK, Small EJ, Sharib J, Harzstark AL, Lin AM, Fong L, Ryan CJ. Effect of the somatostatin analog octreotide acetate on circulating insulin-like growth factor-1 and related peptides in patients with non-metastatic castration-resistant prostate cancer: results of a phase II study. Urol Oncol. 2012 Jul-Aug;30(4):408-14. doi: 10.1016/j.urolonc.2010.06.014. Epub 2010 Oct 2.
Results Reference
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Sandostatin for Patients With Androgen Independent Prostate Cancer

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