Skip to content

Trial · Interventional

TerminatedPhase 2Results postedRegistry data

Sandostatin for Patients With Androgen Independent Prostate Cancer

NCTNCT00510224 (opens ClinicalTrials.gov in a new tab)Other idUCSF055514
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
13 participants (actual)
Sponsor
University of California, San Francisco · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Jul 2007
Primary completion
Aug 2009
Completion
Aug 2009
First posted
1 Aug 2007 (estimated)
Last update posted
11 Dec 2013 (estimated)
Conditions
Prostate Cancer

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2007200820092010
  1. Ph 2

    Sandostatin for Patients With Androgen Independent Prostate Cancer

    NCT00510224

    Jul 2007 to Aug 2009

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SandostatinDrug

Arms1

  • Experimental

    1

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. PSA Response

    Time frame · 12 weeks

    Registry 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.

Secondary outcomes(3)

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

    Time frame · Baseline, 12 weeks

    Registry 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).

  2. Grade 4-5 Adverse Events

    Time frame · 12 weeks

  3. Pre Versus Post Treatment Mitogenic Effects.

    Time frame · 12 Weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 12 weeks

PSA Response

GroupValue (Participants)
Octreotide Acetate0
Secondary and other outcome results(3)
Secondary outcomeMedian· Baseline, 12 weeks

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

GroupValue (percent change)
Octreotide Acetate-34.5
Secondary outcomeNumber· 12 weeks

Grade 4-5 Adverse Events

GroupValue (Adverse Events)
Octreotide Acetate0
Secondary outcome· 12 Weeks

Pre Versus Post Treatment Mitogenic Effects.

GroupValue
Octreotide Acetatenot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Octreotide AcetateOctreotide acetate 30mg intramuscular every 28 days–0 / 136 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2012

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.

Friedlander et al. 2012Urologic oncologycited by 17

PMID 20884247DOI 10.1016/j.urolonc.2010.06.014PUB-20884247

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Male
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.