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.

Active, not recruiting

Conditions: Patients with Metastatic Prostate Cancer who have never been treated with Androgen Deprivation Therapy
MedDRA version: 18.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

Registration Number: EUCTR2014-001162-10-NL

Lead Sponsor: European Uro- Oncology Group (EUOG)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Male

Target Recruitment: 60

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

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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

Secondary Outcome Measures

Name	Time	Method

Related Trials

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 anti-androgens.

Active, Not Recruiting

European Uro- Oncology Group (EUOG)

Updated 7/10/2015

An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Chemo-Naïve patients with Progressive Prostate Cancer who have failed Androgen Deprivation Therapy (CRPC patients)

CompletedPhase 2

eids Universitair Medisch Centrum

Updated 3/11/2024

An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Hormono-Sensitive patients with Metastatic Prostate Cancer.

CompletedPhase 2

eids Universitair Medisch Centrum

Updated 4/23/2024

A Phase II, open-label, single-arm, exploratory pharmacogenomic study of single agent eribulin (HALAVEN®) as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer

Active, Not Recruiting

SOLTI

Updated 2/8/2016

A Phase II, open-label, single-arm, exploratory pharmacogenomic study of single agent eribulin (HALAVEN®) as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer

Active, Not Recruiting

SOLTI

Updated 1/25/2016

A Phase II, open-label, single-arm, exploratory pharmacogenomic study of single agent eribulin (HALAVEN®) as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer

Active, Not Recruiting

SOLTI

Updated 1/25/2016

A Phase II exploratory, open-label, single arm study of BYL719 monotherapy, a selective PI3K alpha inhibitor, in adult patients with advanced breast cancer progressing after first line therapy

CompletedPhase 2

Peter MacCallum Cancer Centre

Updated 6/28/2021

A clinical trial to study effects and safety profile of LNP3794 (A Lupin novel product) in patients who have already spread lung cancer and are previously treated with all possible treatments.

Unknown StatusPhase 2

upin Limited Research Park

Updated 11/24/2021

The study will determine if subjects are able to stop eltrombopag treatment while maintaining acceptable platelet levels after their disease has become resistant to treatment (refractory) or has a reoccurrence of symptoms after initial treatment with steroids (relapse)

Active, Not RecruitingPhase 1

ovartis Pharma AG

Updated 3/21/2022

The study will determine if subjects are able to stop eltrombopag treatment while maintaining acceptable platelet levels after their disease has become resistant to treatment (refractory) or has a reoccurrence of symptoms after initial treatment with steroids (relapse)

Active, Not RecruitingPhase 1

ovartis Pharma AG

Updated 4/6/2020

AI-Powered Research

Premium Access

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.

Recruitment & Eligibility

Study & Design

Related Trials

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 anti-androgens.

An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Chemo-Naïve patients with Progressive Prostate Cancer who have failed Androgen Deprivation Therapy (CRPC patients)

An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Hormono-Sensitive patients with Metastatic Prostate Cancer.

A Phase II, open-label, single-arm, exploratory pharmacogenomic study of single agent eribulin (HALAVEN®) as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer

A Phase II, open-label, single-arm, exploratory pharmacogenomic study of single agent eribulin (HALAVEN®) as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer

A Phase II, open-label, single-arm, exploratory pharmacogenomic study of single agent eribulin (HALAVEN®) as neoadjuvant treatment for operable Stage I-II HER2 non-overexpressing breast cancer

A Phase II exploratory, open-label, single arm study of BYL719 monotherapy, a selective PI3K alpha inhibitor, in adult patients with advanced breast cancer progressing after first line therapy

A clinical trial to study effects and safety profile of LNP3794 (A Lupin novel product) in patients who have already spread lung cancer and are previously treated with all possible treatments.

The study will determine if subjects are able to stop eltrombopag treatment while maintaining acceptable platelet levels after their disease has become resistant to treatment (refractory) or has a reoccurrence of symptoms after initial treatment with steroids (relapse)

The study will determine if subjects are able to stop eltrombopag treatment while maintaining acceptable platelet levels after their disease has become resistant to treatment (refractory) or has a reoccurrence of symptoms after initial treatment with steroids (relapse)

Clinical Trial Alerts