drugset / Trial / NCT02631616

Treatment With Sandostatin in Patients With Castrate Resistance Prostate Cancer Showing Uptake of 68Ga-DOTATET

NCT02631616

Phase 1 Unknown 30 enrolled Hadassah Medical Organization
NaSingle-groupOpen-labelTreatment

Summary

Purpose: Castrate resistance prostate cancer (CRPC) often shows histological evidence of neuroendocrine differentiation (NED). Recently the investigators initiated a research project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine tumors-NET) in PET/CT in patients with CRPC. In 4/8 patients studied thus far, uptake of the tracer in bone metastases was found. It has been shown that monthly injections of Somatostatin lengthen overall survival in patients with NET. The purpose of the current project is to examine the ability of Somatostatin to stabilize or possibly reverse metastases in patients with CRPC that express high level of somatostatin receptors in 68Ga-DOTATET PET/CT. Materials and Methods: 30 patients with CRPC will be studied with 68Ga-DOTATET PET/CT. Patients showing uptake of the radiotracer 68Ga-DOTATET in at two least to metastases will be considered eligible for the study. These patients will be evaluated biochemically and clinically and will be treated with monthly injections of Sandoatatin LAR - 30mg. Clinical, biochemical and imaging studies (68Ga-DOTATET PET/CT) will be repeated after 4 and 12 months of treatment. Responding patients (stabilization or decrease in the number and SUV of metastases) will be subjected to continued therapy until progression.

Timeline

Start
2016-02
Primary completion
2017-02
Completion
2018-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatostatin Traditional medicine (herbal / TCM) 30 mg

Indications