Sandostatin for Patients With Androgen Independent Prostate Cancer

This study has been terminated.
(Stopped at interim analyses phase due to lack of efficacy)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00510224
First received: July 30, 2007
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Sandostatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • PSA Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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. [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Pre Versus Post Treatment Mitogenic Effects. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: July 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Sandostatin
Sandostatin 30mg intramuscular every 28 days

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510224

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Novartis
Investigators
Principal Investigator: Charles Ryan, MD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00510224     History of Changes
Other Study ID Numbers: UCSF055514
Study First Received: July 30, 2007
Results First Received: October 17, 2013
Last Updated: October 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Octreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014