NCT04113005

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a single site, prospective, Phase 1 pilot trial intended to evaluate the safety and tolerability of adding one IV dose of Desmopressin to CRPC subjects at least 30 minutes prior to commencing standard IV Docetaxel treatment7,8.

Detailed description

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. Furthermore, for detailed documentation of AEs during the first 21 days following Desmopressin/Docetaxel therapy, subjects will be assessed weekly via phone, and in person by the investigator/treating medical oncologist before the second dose of docetaxel.

Conditions

• Castrate Resistance Prostate Cancer

Interventions

Type	Name	Description
DRUG	Desmopressin	To evaluate the safety and tolerability of Desmopressin in CRPC subjects starting Docetaxel treatment. Additionally, CTCs will be collected before and after Desmopressin/Docetaxel treatment to evaluate therapeutic efficacy.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-04-30
• Completion: 2020-10-01
• First posted: 2019-10-02
• Last updated: 2019-10-02