Sandostatin for Patients With Androgen Independent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Sandostatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1 Drug: Sandostatin
Sandostatin 30mg intramuscular every 28 days

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. Grade 4-5 Adverse Events [ Time Frame: 12 weeks ]
  3. Pre Versus Post Treatment Mitogenic Effects. [ Time Frame: 12 Weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00510224

United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Charles Ryan, MD University of California, San Francisco

Publications of Results:
Responsible Party: University of California, San Francisco Identifier: NCT00510224     History of Changes
Other Study ID Numbers: UCSF055514
First Posted: August 1, 2007    Key Record Dates
Results First Posted: December 11, 2013
Last Update Posted: December 11, 2013
Last Verified: October 2013

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