- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04586543
Clinical Trial of Selegiline Plus Docetaxel for the Treatment of Metastatic, Castrate-resistant Prostate Adenocarcinoma
A Clinical Trial of Selegiline Plus Docetaxel for the Treatment of Metastatic, Castrate-resistant Prostate Adenocarcinoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: László Mangel, Prof. MD
- Phone Number: +36-72-536-480
- Email: mangel.laszlo@pte.hu
Study Locations
-
-
Baranya
-
Pécs, Baranya, Hungary, 7624
- Recruiting
- University of Pécs, Clinical Centre, Department of Oncotherapy
-
Contact:
- László Mangel, Prof. MD
- Phone Number: +36-72-536-480
- Email: mangel.laszlo@pte.hu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years or older male patients,
- Histologically or cytologically confirmed prostate adenocarcinoma
- Radiologically confirmed metastatic disease,
- Eligibility to receive oral therapy,
- Suitable for docetaxel therapy,
- Patients with castration-resistant prostate carcinoma who eligible to first-line docetaxel therapy or patients with castration-resistant prostate cancer who progressed after second-generation hormone therapy (abiraterone or enzalutamide) with pre-chemotherapy indication and eligible to second-line docetaxel therapy
- At least 4 weeks has elapsed between the last antiandrogenic therapy and the inclusion (at least 6 weeks in case of bicalutamide),
- Planned docetaxel treatment,
- Eastern Cooperative Oncology Group (ECOG) performance status: ≤ 2,
- Estimated life expectancy of more than 12 weeks,
- Adequate analgesic therapy as required;
- Patients must be able to follow the diet and medical instructions,
- Use of effective contraception in men of childbearing age,
- Provision of signed, written information consent
Exclusion Criteria:
- De novo metastatic patients who needs immediate docetaxel therapy;
- Within 4 weeks prior to randomisation, the patient has received other study medication or failed to recover from any adverse events caused from a previously administered study drug
- ≥ Grade 2 anticancer therapy-related toxicity (except alopecia),
- Has had radiotherapy or immunotherapy within 4 weeks prior to treatment,
- Has had a surgery within 4 weeks prior to treatment,
- Known or suspected brain metastasis (stable patients with locally treated, asymptomatic brain metastases are not excluded),
Inadequate laboratory function:
- Absolute neutrophil count <1.5 x 109 /L (1,500 per mm3),
- Platelet count < 100 x 109 /L (100 000 per mm3),
- Hemoglobin ≤9.0 g/dL,
- Serum bilirubin > ULN,
- AST or ALT
i.>2.5 x ULN in patient without liver metastases, ii.>5x ULN in patients with liver metastases.
Cardiological status:
- Uncontrolled hypertension (BP ≥ 150/95 with hypertension treatment)
- Heart failure (NYHA III or higher),
- Current or former diagnosis of cardiomyopathy,
- LVEF ≤ 50%,
- Atrial fibrillation with >100bpm pulse,
- Unstable ischemic heart disease (myocardial infarction within 6 months or angina that require more than one nitrate therapy each week).
- Other uncontrolled or severe systemic disease, active infection, hepatitis B, hepatitis C, HIV,
- Uncontrolled seizure disorder,
- Active gastric and duodenal ulcers,
- Recurrent nausea and vomiting, chronic gastrointestinal disease or intestinal resection that prevents proper absorption,
- Severe psychiatric illness (including but not limited to manic psychiatric disorder, schizophrenia, bipolar disorder, major depression requiring hospitalization) or social disturbance that limits eligibility for examination,
- History of other malignancy within the last 5 years (except properly treated basalioma or squamous cell carcinoma of the skin and in situ carcinoma),
- History of allergic reaction to phenelzine, selegiline or other monoamine oxidase inhibitors (MAOIs) biological agents or similar chemical ingredients,
- History of allergic reaction to docetaxel therapy or its ingredients,
- Significant peripheral neuropathy (≥ Grade 2),
Selegiline is contra-indicated for concomitant use with:
- Certain narcotic analgesics (eg. pethidine),
- Drugs that enhance the sympathetic nervous system,
- Other MAO inhibitors,
- Drugs similar to MAO inhibitors,
- Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs),
- Tricyclic antidepressants.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Selegiline+ Docetaxel
Selegiline and plus Docetaxel
|
10 mg selegiline tablet per day
75mg/m2 docetaxel infusion every 3 weeks for maximum of 12 cycles
|
ACTIVE_COMPARATOR: Docetaxel
|
75mg/m2 docetaxel infusion every 3 weeks for maximum of 12 cycles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients without progression at month 9
Time Frame: 12 months
|
Proportion of patients without progression at month 9. Progression can be identified by clinical symptoms, PSA levels, or radiographic imaging as follows, based on PCWG2 criteria:
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 5 years
|
5 years
|
Proportion of patients without progression at month 12
Time Frame: 15 months
|
15 months
|
Proportion of patients without progression at month 18
Time Frame: 21 months
|
21 months
|
Progression-free survival (biochemical, clinical, radiological
Time Frame: 5 years
|
5 years
|
Duration of PSA response
Time Frame: 5 years
|
5 years
|
Radiological Response Rate
Time Frame: 5 years
|
5 years
|
PSA Response Rate
Time Frame: 5 years
|
5 years
|
Health-Related Quality of Life
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Male
- Prostatic Diseases
- Prostatic Neoplasms
- Adenocarcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Neuroprotective Agents
- Protective Agents
- Psychotropic Drugs
- Antidepressive Agents
- Monoamine Oxidase Inhibitors
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Docetaxel
- Selegiline
Other Study ID Numbers
- MAO201901
- 2019-002685-12 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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