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

NCT04113005 | Unknown Early Phase 1

• 1 other identifier: Desmopressin Trial
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Castrate Resistance Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  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). The proportion of subjects presenting with hyponatremia at 48-hour time point; severity of hyponatremia as per CTCAE Version 4.03 (Appendix B).

  12 months

Study Arms (1)

Desmopressin

EXPERIMENTAL

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

Drug: Desmopressin

Interventions

Desmopressin DRUG

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.

Desmopressin

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Platelet count ≥125 x 109/L;
• Creatinine ≤1.5 x upper limit of normal;
• Urea ≤1.5 x upper limit of normal;
• Bilirubin ≤1.1 x upper limit of normal (unless elevated secondary to conditions such as Gilbert's disease);
• Aspartate transaminase (AST) ≤1.5 x upper limit of normal;
• Alanine transaminase (ALT) ≤1.5 x upper limit of normal;
• Castrate serum testosterone level (\< 1.7 nmol/L).

You may not qualify if:

• Known Desmopressin intolerability.
• Any state of known congestive heart disease (CHF class \>1).
• Sodium blood levels \< 135 mEq/ml at enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status \>1.
• Moderate or severe chronic kidney disease (eGFR \<60 mL/min).
• Prior use of docetaxel for CRPC.
• ≤30 days prior to study treatment received or had:
• Transfusion (platelets or red blood cells), or hematopoetic growth factors;
• Any type of chemotherapy;
• Any form of hormonal treatment with the exception of the continuous GnRH analogues required to maintain castrate state;
• Corticosteroid treatment equivalent to \>10 mg of Prednisone orally daily;
• An investigational agent for prostate cancer;
• Ongoing Desmopressin therapy at enrollment;
• Major surgery.
• Current use of: Clofibrate, Chlorpropamide, Carbamazepine, Demeclocycline, Lithium, or Norepinephrine.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Sunnybrook Research Institute: collaborator

MeSH Terms

Interventions

Deamino Arginine Vasopressin

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Urban Emmenegger

  Sunnybrook Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Urban Emmenegger, MD

CONTACT

416-480-4928; urban.emmenegger@sunnybrook.ca

Marlene Kebabdjian

CONTACT

416-480-6100; marlene.kebabdjian@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Safety and Tolerability Analysis

Study Record Dates

• First Submitted: September 27, 2019
• First Posted: October 2, 2019
• Study Start: October 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: October 1, 2020
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share