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

NCT02631616 | Unknown Phase 1

• 1 other identifier: NEPros-HMO-CTIL
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostatic Neoplasms

Keywords

Prostatic Neoplasma, Castration-Resistant; neuroendocrine differentiation; 68Ga-DOTATET; PET/CT

Outcome Measures

Primary Outcomes (1)

• Clinical response

  QOL 30 questioner

  4 months

Secondary Outcomes (2)

• Biochemical response

  4 months

• Imaging response

  4 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Monthly injections of Somatostatin (Sandoatatin LAR - 30mg)

Drug: Somatostatin

Interventions

Somatostatin DRUG

Monthly injections of Somatostatin

Also known as: Sandoatatin LAR - 30mg

Treatment arm

Eligibility Criteria

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

You may qualify if:

• Patients with histologically proven prostate cancer.
• Hormonal treatment (either surgical orchiectomy or medical castration with LHRH agonist or antagonist).
• Proven castration levels (serum Testosterone\< 50 ng/dl)
• Radiological evidence of metastatic disease.
• Uptake of the radiotracer 68Ga-DOTATET in at two least to metastases.

You may not qualify if:

• \. Participation in another trial.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Somatostatin

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)

Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pancreatic Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Ofer N. Gofrit, MD, PhD

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 16, 2015
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2018
• Last Updated: December 16, 2015

Record last verified: 2015-12