Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer

What Was Tested

In this early phase 1 trial, researchers set out to test Desmopressin.

It had 1 arm (groups): Desmopressin (experimental).

Aim to evaluate the safety and tolerability of Desmopressin in CRPC subjects starting Docetaxel treatment.

The registry classes the interventions as drug.

More on the Plan

Following Desmopressin/Docetaxel treatment subjects will be subjected to routine medical oncology follow-up, including clinical appointments, laboratory and imaging workup as well as additional Docetaxel therapy every 21 days as indicated.

An additional study clinical appointment with blood work will be organized two days post Desmopressin/Docetaxel treatment.

Who Took Part

10 planned participants were the target.

It was open to men only.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Men over 18 years of age with histologically confirmed adenocarcinoma of the prostate. Signed Informed Consent Form indicating that the subject understands the purpose of, and procedures required for, the study and is willing to participate in the study. Castration-resistant stage of disease about to be treated with Docetaxel. Baseline laboratory values as stated below:. Absolute neutrophil count ≥1.5 x 109/L;.

The full record lists 12 inclusion and 18 exclusion criteria; among the exclusions: known desmopressin intolerability; any state of known congestive heart disease (chf class \>1); sodium blood levels \< 135 meq/ml at enrollment.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Desmopressin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-10-01 with completion listed for 2020-04-30.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of subjects presenting with AEs within a 21-day period of time post Desmopressin/Docetaxel treatment; nature and severity of AEs (as per Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03, Appendix B) (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Desmopressin in 10 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 Desmopressin compound page, all human trials.