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Study of Lanreotide in Non Metastatic Castration-resistant Prostate Cancer Patients
Plain-language guide to NCT01313273: phase 3 randomized trial of Lanreotide, 3 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01313273
- Phase
- phase 3
- Status
- terminated early
- Start
- 2011-06
- Completion (planned or actual)
- 2013-06
- Participants
- 3 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Prostate Cancer
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Lanreotide.
It had two arms (groups): Arm A (other) and Arm B (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 3 actual participants took part.
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: Histologically proven diagnosis of prostate cancer. Evidence of PSA progression despite castrate levels of testosterone (\<50 ng/dL) following orchiectomy or during therapy with luteinizing hormone releasing hormone agonists (LHRH-a). Patients with non-metastatic or stable metastatic disease.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: patients who according to the investigator opinion are candidates to be treated immediately with chemotherapy (e.g. docetaxel); first line treatment with antiandrogen in monotherapy; visceral metastasis.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Lanreotide group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Lanreotide study: the participants and staff both knew the treatment.
It started in 2011-06 with completion listed for 2013-06.
It ran at 1 site in Italy.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Progression-free Survival (time frame: Week 96).
It also tracked 3 secondary outcomes, for example Prostate Specific Antigen (PSA) Response and Median Time to PSA Response.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Lanreotide in 3 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Lanreotide compound page, all human trials.
Our Notes on the Compound
Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.
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.