Clinical trial · Interventional
Sandostatin for Patients With Androgen Independent Prostate Cancer
A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer
NCT00510224CI-TRIAL-00012935terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stopped at interim analyses phase due to lack of efficacy
Summary
Brief summary (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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sandostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: Sandostatin
Primary outcomes (1)
- measure
- PSA Response
- timeFrame
- 12 weeks
- 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)
- measure
- Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.
- timeFrame
- Baseline, 12 weeks
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (1)
- RESULTFriedlander 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