Castrate Resistance Prostate CancerEarly Phase 1NCT04113005
Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer
A Early Phase 1 study testing Desmopressin in people with Castrate Resistance Prostate Cancer, run by Sunnybrook Health Sciences Centre.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Castrate Resistance Prostate Cancer
- What is being tested?
- Desmopressin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Oct 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Desmopressin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin | Experimental | Aim to evaluate the safety and tolerability of Desmopressin in CRPC subjects starting Docetaxel treatment. Receives: Drug: Desmopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Apr 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Castrate Resistance Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Safety and Tolerability Analysis
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Responsible party
- Sponsor
- Investigators
- Urban Emmenegger, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113005
- Sponsor's protocol ID
- Desmopressin Trial
- Status last verified
- Oct 2019
- First submitted
- 27 Sep 2019
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability Analysis of Combining Desmopressin With Docetaxel for the Treatment of Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04113005
- Acronym / sponsor ID
- Desmopressin Trial
- Conditions
- Castrate Resistance Prostate Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 2 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Safety and Tolerability Analysis
| Arm | Type | Receives |
|---|---|---|
| Desmopressin | Experimental | Drug: DesmopressinAim to evaluate the safety and tolerability of Desmopressin in CRPC subjects starting Docetaxel treatment. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DesmopressinTo 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. | Drug | Desmopressin |
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
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
Related trials for Castrate Resistance Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer
Metastatic Prostate Cancer
Active, not recruitingPhase 3
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1).
Metastatic Castrate Resistant Prostate Cancer (mCRPC)
RecruitingPhase 3
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 2
Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prostate Cancer
Prostate Cancer, Metastatic Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urban Emmenegger principal investigator
Sunnybrook Research Institute
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Desmopressin in people with Castrate Resistance Prostate Cancer, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Urban Emmenegger, MD (416-480-4928, urban.emmenegger@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.