An exploratory study to assess the efficacy using imaging of oral enzalutamide in patients with therapy-resistant prostate cancer who have not been treated with androgen deprivation.

An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Hormono-Naïve patients with Metastatic Prostate Cancer who have never before received Androgen Deprivation Therapy. - NA

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001162-10-NL

Enrollment

Registered

2015-04-13

Start date

2015-05-06

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with Metastatic Prostate Cancer who have never been treated with Androgen Deprivation Therapy MedDRA version: 18.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Xtandi Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Adult metastatic hormone-naïve prostate cancer patients with progressive metastatic disease requiring treatment and who have at least one measurable metastasis on either PET/CT or WB MRI or both. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: Previous androgen deprivation therapy / Known or suspected brain metastasis or active leptomeningeal disease / Evidence of clinically relevant liver/kidney disease/bone marrow failure / history of seizure or any condition that may predispose to seizure / history of loss of consciousness or transient ischemic attack within 12 months of enrollment / Contra-indication for MRI (e.g. pacemaker).

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatment with Enzalutamide in patients with metastatic prostate cancer. 2. To evaluate how these 2 imaging modalities perform compared to traditional serial PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and response to treatment in these patients.;Secondary Objective: Not applicable;Primary end point(s): Progression-Free Survival (PFS) at 6 and 12 months;Timepoint(s) of evaluation of this end point: 6 and 12 months	—

Measure

Time frame

Main Objective: 1. To evaluate the feasibility of 18F-FDG PET/CT, or WB MRI or both to determine metastatic tumour load before and after treatment with Enzalutamide in patients with metastatic prostate cancer. 2. To evaluate how these 2 imaging modalities perform compared to traditional serial PSA measurements and bone scan in assessing metastatic tumour load, progressive disease and response to treatment in these patients.;Secondary Objective: Not applicable;Primary end point(s): Progression-Free Survival (PFS) at 6 and 12 months;Timepoint(s) of evaluation of this end point: 6 and 12 months

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 6 and 12 months;Secondary end point(s): Biochemical (PSA) response defined as prostate-specific antigen (PSA) nadir. PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements). Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria. Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression. A Symptomatic Skeletal Event (SSE) is defined as external beam radiation therapy (EBRT) to relieve skeletal pain, new symptomatic pathologic bone fracture, occurrence of spinal cord compression or tumour-related orthopedic surgical intervention, or change of anti-neoplastic therapy to treat bone pain. CTC measurements and comparison with radiological PFS at 6 and 12 months. Circulating testosterone (T), dihydrotestosterone (DHT), sex hormone binding globulin (SHBG), androstenedione, DHEA, luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin and estradiol assessed as temporal changes of absolute values and temporal percentage changes of baseline values. Biomarker assessment / correlative: (next to PSA) biomarkers of bone turnover, Alkaline Phosphatase, PTH, Ca, Phosphate, 25 (OH)Vitamin D, beta-CTX (beta-crosslaps), PN1P. The safety of Enzalutamide as assessed by serious adverse events (SAEs), severity of adverse events (AEs) graded by National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), discontinuation due to AEs, as well as new clinically significant changes in physical exam findings, vital signs, laboratory values, and ECGs. Time to symptomatic progression (including death due to prostate cancer) Time to first radiological or symptomatic progression Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 6 and 12 months;Secondary end point(s): Biochemical (PSA) response defined as prostate-specific antigen (PSA) nadir. PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements). Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria. Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression. A Symptomatic Skeletal Event (SSE) is defined as external beam radiation therapy (EBRT) to relieve skeletal pain, new symptomatic pathologic bone fracture, occurrence of spinal cord compression or tumour-related orthopedic surgical intervention, or change of anti-neoplastic therapy to treat bone pain. CTC measurements and comparison with radiological PFS at 6 and 12 months. Circulating testosterone (T), dihydrotestosterone (DHT), sex hormone binding globulin (SHBG), androstenedione, DHEA, luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin and estradiol assessed as temporal changes of absolute values and temporal percentage changes of baseline values. Biomarker assessment / correlative: (next to PSA) biomarkers of bone turnover, Alkaline Phosphatase, PTH, Ca, Phosphate, 25 (OH)Vitamin D, beta-CTX (beta-crosslaps), PN1P. The safety of Enzalutamide as assessed by serious adverse events (SAEs), severity of adverse events (AEs) graded by National Cancer Institute’s Common Terminology Criteria for Adverse Events (NCI-CTCAE), discontinuation due to AEs, as well as new clinically significant changes in physical exam findings, vital signs, laboratory values, and ECGs. Time to symptomatic progression (including death due to prostate cancer) Time to first radiological or symptomatic progression Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and

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Countries

Austria, Belgium, Germany, Netherlands, Spain, Switzerland

Contacts

Public ContactProf. dr S. Osanto

EUOG

s.osanto@lumc.nl31715269111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026