Study evaluating efficacy of enzalutamide and variants of androgens receptor in metastatic castration resistant prostate cancer patients with visceral disease

Phase 1

• Conditions: metastatic prostate cancer resistant to castration with visceral disease; MedDRA version: 20.0Level: LLTClassification code 10007453Term: Carcinoma of the prostate metastaticSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2015-004596-72-IT
• Lead Sponsor: FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-09
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 68

Inclusion Criteria

- Biopsy (primary tumour or metastases) confirming the diagnosis of prostate adenocarcinoma
- Documented measurable metastatic visceral disease (according to RECIST 1.1 criteria)
- Life expectancy > 3 months
- Patients may have received previous therapy including chemotherapy (including docetaxel)
- Progressive disease by PSA or imaging in the setting of medical or surgical castration. Disease progression for study entry is defined as one or more of the following three criteria (according with PCWG2)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 18
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Metastases in the brain or active epidural disease
- History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer
- Prior treatment with abiraterone acetate
- Treatment (concomitant or in the previous 2 weeks) with anti-androgens (eg. Bicalutamide, nilutamide, flutamide) or 5-a reductase inhibitors (eg. finasteride, dutasteride)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified