Clinical Trial of Selegiline Plus Docetaxel for the Treatment of Metastatic, Castrate-resistant Prostate Adenocarcinoma

NCT04586543 | Unknown Phase 2

• 2 other identifiers: MAO2019012019-002685-12
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical study is to evaluate the effectiveness and safety of selegiline plus docetaxel therapy compared to the standard of care - docetaxel therapy - among patients diagnosed with metastatic, castrate-resistant prostate adenocarcinoma.

Conditions

Metastatic Castration-resistant Prostate Cancer; Adenocarcinoma of the Prostate

Keywords

selegiline; hormone-refractory prostate cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients without progression at month 9

  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: 1. Progression based on clinical symptoms: 1. Decline in ECOG performance status (≥ grade 3), 2. Initiation of newly adjusted chronic opioid analgesic therapy, which may be, i.Use of oral opioid for at least 3 weeks ii.Use of parenteral opioid for at least 7 days c.Necessity to initiate alternative cytotoxic chemotherapy or other active systemic oncology treatment d.Immediate need for radiation or surgical intervention to treat tumor progression OR 2. PSA progression: Date at which the PSA level is increased by at least 25% relative to nadir and at least 2 ng / mL absolute increase compared to the nadir. Values are confirmed 4-6 weeks later by a test. OR 3. Radiological 1. Progression by RECIST 1.1. 2. Bone scan progression: A total of ≥ 2 new lesion compared to baseline

  12 months

Secondary Outcomes (8)

• Proportion of patients without progression at month 12

  15 months

• Proportion of patients without progression at month 18

  21 months

• Progression-free survival (biochemical, clinical, radiological

  5 years

• Overall survival

  5 years

• Duration of PSA response

  5 years

Study Arms (2)

Selegiline+ Docetaxel

EXPERIMENTAL

Selegiline and plus Docetaxel

Drug: Selegiline; Drug: Docetaxel

Docetaxel

ACTIVE COMPARATOR

Docetaxel

Drug: Docetaxel

Interventions

Selegiline DRUG

10 mg selegiline tablet per day

Selegiline+ Docetaxel

Docetaxel DRUG

75mg/m2 docetaxel infusion every 3 weeks for maximum of 12 cycles

Docetaxel; Selegiline+ Docetaxel

Eligibility Criteria

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

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• László Mangel: lead
• E-Group ICT Software Informatikai Zrt.: collaborator

Study Sites (1)

University of Pécs, Clinical Centre, Department of Oncotherapy

Pécs, Baranya, 7624, Hungary

RECRUITING

MeSH Terms

Interventions

Selegiline; Docetaxel

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Central Study Contacts

László Mangel, Prof. MD

CONTACT

+36-72-536-480; mangel.laszlo@pte.hu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof MD

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 14, 2020
• Study Start: May 18, 2020
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: October 14, 2020

Record last verified: 2020-10

Locations

HU (1)