Sandostatin for Patients With Androgen Independent Prostate Cancer

NCT00510224 | Terminated Phase 2 Results DMC

• 1 other identifier: UCSF055514
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (3)

• Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.

  Baseline, 12 weeks

• Grade 4-5 Adverse Events

  12 weeks

• Pre Versus Post Treatment Mitogenic Effects.

  12 Weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: Sandostatin

Interventions

Sandostatin DRUG

Sandostatin 30mg intramuscular every 28 days

1

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Novartis: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (1)

• 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.

  PMID: 20884247 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Octreotide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Charles J. Ryan, MD
• Organization: UCSF

ryanc@medicine.ucsf.edu

415-353-9279

Study Officials

• Charles Ryan, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2007
• First Posted: August 1, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 11, 2013
• Results First Posted: December 11, 2013

Record last verified: 2013-10

Locations

US (1)