Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer
Primary Purpose
Castrate Resistance Prostate Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Desmopressin
Sponsored by
About this trial
This is an interventional treatment trial for Castrate Resistance Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
- 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).
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- 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.
- History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated (brain imaging for asymptomatic subjects is not required).
- Current symptomatic cord compression requiring surgery or radiation therapy (once successfully treated and there has been no progression, subjects are eligible for the study).
- Uncontrolled medical conditions such as diabetes mellitus, angina pectoris, serious cardiac arrhythmia, severe hypertension, or active infection requiring systemic antibiotics, or any event such as myocardial infarction, cerebrovascular accident, or pulmonary embolism within 3 months prior to protocol therapy, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Desmopressin
Arm Description
Aim to evaluate the safety and tolerability of Desmopressin in CRPC subjects starting Docetaxel treatment.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT04113005
First Posted
September 27, 2019
Last Updated
October 1, 2019
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Sunnybrook Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04113005
Brief Title
Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer
Official Title
Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Anticipated)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Sunnybrook Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castrate Resistance Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Safety and Tolerability Analysis
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Desmopressin
Arm Type
Experimental
Arm Description
Aim to evaluate the safety and tolerability of Desmopressin in CRPC subjects starting Docetaxel treatment.
Intervention Type
Drug
Intervention Name(s)
Desmopressin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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).
Description
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).
Time Frame
12 months
10. Eligibility
Sex
Male
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
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).
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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.
History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated (brain imaging for asymptomatic subjects is not required).
Current symptomatic cord compression requiring surgery or radiation therapy (once successfully treated and there has been no progression, subjects are eligible for the study).
Uncontrolled medical conditions such as diabetes mellitus, angina pectoris, serious cardiac arrhythmia, severe hypertension, or active infection requiring systemic antibiotics, or any event such as myocardial infarction, cerebrovascular accident, or pulmonary embolism within 3 months prior to protocol therapy, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Urban Emmenegger, MD
Phone
416-480-4928
Email
urban.emmenegger@sunnybrook.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marlene Kebabdjian
Phone
416-480-6100
Ext
2890
Email
marlene.kebabdjian@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urban Emmenegger
Organizational Affiliation
Sunnybrook Research Institute
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer
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