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Treatment With Sandostatin in Patients With Castrate Resistance Prostate Cancer Showing Uptake of 68Ga-DOTATET
Plain-language guide to NCT02631616: phase 1 interventional trial of Somatostatin, 30 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02631616
- Phase
- phase 1
- Status
- status unknown
- Start
- 2016-02
- Completion (planned or actual)
- 2017-02
- Participants
- 30 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostatic Neoplasms
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Somatostatin.
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.
It had 1 arm (groups): Treatment arm (experimental).
The registry classes the interventions as drug.
More on the Plan
Introduction: Neuroendocrine tumors (NET) present receptors to somatostatin.
This feature is utilized therapeutically in patients with metastatic NET.
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.
Who Took Part
The registry lists 30 planned participants were the target.
It was open to men only aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with histologically proven prostate cancer. 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.
The full record lists 5 inclusion and 0 exclusion criteria.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Somatostatin study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2016-02 with completion listed for 2017-02.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Clinical response (time frame: 4 months).
It also tracked 2 secondary outcomes, for example Biochemical response and Imaging response.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Somatostatin in 30 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Somatostatin compound page, all human trials.
Our Notes on the Compound
Somatostatin: A 14-amino-acid hormone that switches off the release of several other hormones, including growth hormone and insulin.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.