- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02631616
Treatment With Sandostatin in Patients With Castrate Resistance Prostate Cancer Showing Uptake of 68Ga-DOTATET
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.
Study Overview
Detailed Description
Introduction: Neuroendocrine tumors (NET) present receptors to somatostatin. This feature is utilized therapeutically in patients with metastatic NET. Monthly injection of Somatostatin was shown to lengthen overall survival (compared to placebo) in these patients. From histological studies it is known that advanced prostate cancer often shows neuroendocrine differentiation (NED). This is considered one of the mechanisms of "escape" of tumor cells from androgen deprivation therapy. Recently the investigatros initiated a research project investigating the uptake of the radiotracer 68Ga-DOTATET (a marker of neuroendocrine tumors-NET) in PET/CT in patients with castrate resistance prostate cancer. In 4/8 patients studied thus far, uptake of the tracer in bone metastases was found.
Purpose: The purpose of the current project is to examine the ability of LAR Somatostatin to stabilize or possibly reverse metastases in patients with castrate resistance prostate cancer that express high level of somatostatin receptors.
The aims of the study are:
- To detect biochemical response (PSA and chromogranin A)
- To detect PET response (in repeated PET/CT, 68Ga-DOTATET).
- To detect clinical response (QOL 30 questioner).
- To detect adverse response.
Materials and Methods:
- Eligible patients will be evaluated by: serum levels of PSA, chromogranin A, Pro GRP and possibly other non-genetic markers and by QOL 30 questioner
- Treatment with monthly injections of Sandoatatin LAR - 30mg will be initiated.
- Evaluation will be done after 4 injections and will include: blood tests for PSA and chromogranin A, Pro GRP and possibly other non-genetic markers and by QOL 30 questioner and by PET/CT with 68Ga-DOTATET. Similar evaluation will be done after 12 injections. Responding patients (stabilization or decrease in the number and SUV of metastases) will be subjected to continued therapy until progression.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
1. Participation in another trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment arm
Monthly injections of Somatostatin (Sandoatatin LAR - 30mg)
|
Monthly injections of Somatostatin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical response
Time Frame: 4 months
|
QOL 30 questioner
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical response
Time Frame: 4 months
|
Blood test for PSA (in ng/ml)
|
4 months
|
Imaging response
Time Frame: 4 months
|
PET/CT with 68Ga-DOTATET
|
4 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NEPros-HMO-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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