An International Study to Evaluate the effectiveness of continuing treatment of enzalutamide after PSA Progression in Patients who have not yet received chemotherapy.

Phase 1

• Conditions: Patients With Chemotherapy Naïve Metastatic Castration Resistant Prostate Cancer.; MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000722-54-DK
• Lead Sponsor: Medivation, Inc., a wholly owned subsidiary of Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 509

Inclusion Criteria

Age 18 years or older and willing and able to provide informed consent;
Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, or signet cell or small cell features;
Presence of metastatic disease as assessed by CT/MRI and/or whole body radionuclide bone scan;
Throughout study, ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
Testosterone = 1.73 nmol/L (= 50 ng/dL) at screening;
Progressive disease on androgen deprivation therapy at screening defined as a minimum of 3 sequential rising PSA values (PSA1 < PSA2 < PSA3) assessed by the local laboratory (local PSA) with an interval of = 1 week between each determination;
The most recent local PSA and the screening PSA assessed by the central laboratory should be = 2 µg/L (= 2 ng/mL). In the event of prior androgen receptor inhibitor use, the most recent local PSA and the screening PSA assessed by the central laboratory (central PSA) must be obtained at least 4 weeks after the last dose of the androgen receptor inhibitor.

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 89
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 420

Exclusion Criteria

Prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for the treatment of prostate cancer or participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis (unless treatment was placebo);
Medical contraindication to prednisone use; Treatment with hormonal therapy (eg, androgen receptor inhibitors, 5 alpha reductase inhibitors) or biologic therapy for prostate cancer (other than denosumab, GnRH agonist/antagonist therapy, or corticosteroid therapy) within 4 weeks of screening;
Use of an investigational agent within 4 weeks of the screening visit;
Current or previously treated brain metastasis or active leptomeningeal disease.

Study & Design

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