Imaging Staging and Response Prediction in Metastatic Hormono-Sensitive Prostate Cancer Patients Receiving Enzalutamide

NCT02815033 | Completed Phase 2

• 1 other identifier: EudraCT Number: 2014-001162-10
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the clinical utility of 11C or 18F-Choline Positron Emission Tomography (PET)/Computed Tomography (CT) scan, Whole Body Magnetic Resonance Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in response prediction to treatment with Enzalutamide in Hormono-Sensitive Metastatic Prostate Cancer patients. The study will assess 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 with Enzalutamide. In addition measurements of serially collected circulating tumour cell (CTC) samples, cell-free tumour DNA and RNA will be performed in order to evaluate their predictive value in terms of response measurement.

Conditions

Prostate Cancer Metastatic

Keywords

Hormono-Sensitive prostate cancer; Enzalutamide; Imaging; PET/CT; Whole body MRI; Circulating tumour cells; Cell-free tumour DNA

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) at 6 and 12 months.

  Radiological progression is defined by any of the following criteria: * Soft tissue lesions: Progressive disease on Choline (11C or 18F) PET/CT or Whole Body MRI by RECIST 1.1. Bone or bone marrow lesions: Progressive disease on PET/CT or MRI as evidenced by new lesions or an increase in size of 25% of the sum of target lesions. * Conversion of the Choline (11C or 18F) PET signal of the metastases at 2 weeks, 2 or 6 months compared to baseline PET which by comparing it to PFS at 6 and 12 months may be an indicator or drug response. Radiological PFS at 6 and 12 months will be compared to a) PET signal conversion and to b) PSA measurements, and changes in number of lesions on the bone scan (conventional work up).

  6 and 12 months

Secondary Outcomes (21)

• Biochemical response defined as prostate-specific antigen (PSA) nadir

  12 months

• PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements)

  12 months

• Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria

  6 and 12 months

• Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression

  6 and 12 months

• Occurrence of Symptomatic Skeletal Events (SSE) evaluated by combination of clinical and radiological assessments

  12 months

Study Arms (1)

Single arm

OTHER

Experimental: Single arm Subjects will receive 1 dd 160 mg Enzalutamide orally continuously until progressive disease occurs. Serial PSA measurements, PET/CT scans, Whole Body MRI, bone scans will be performed to assess metastatic tumour load, progressive disease and response to treatment.

Drug: Enzalutamide; Procedure: 11C or 18F-Choline PET/CT; Procedure: Whole body MRI; Procedure: Bone scan

Interventions

Enzalutamide DRUG

Also known as: Xtandi

Single arm

11C or 18F-Choline PET/CT PROCEDURE

Single arm

Whole body MRI PROCEDURE

Single arm

Bone scan PROCEDURE

Single arm

Eligibility Criteria

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

You may qualify if:

• Male aged 18 years or older;
• Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
• Three consecutive rises of PSA, 1 week apart, resulting in two 50% increases over the nadir, with PSA of at least \> 2 ng/mL but preferably \>20 ng/mL;
• Progressive disease defined by rising PSA levels plus by evidence of progressive and measurable soft tissue or bone disease by 11C or 18F-Choline PET/CT, Whole Body MRI or both;
• No prior treatment with cytotoxic chemotherapy;
• Eastern Cooperative Oncology Group (ECOG) score 0-2;
• A life expectancy of at least 12 months;
• Written informed consent;

You may not qualify if:

• Treatment with androgen deprivation therapy with a gonadotropin-releasing hormone analogue, luteinizing hormone-releasing hormone antagonist, or bilateral orchiectomy within 6 months of enrolment (Day1 visit);
• Treatment with anti-androgens such as bicalutamide, nilutamide or flutamide within 6 weeks of enrolment (Day 1 visit);
• Treatment with 5-α reductase inhibitors (finasteride, dutasteride), estrogens, cyproterone acetate within 4 weeks of enrolment (Day 1 visit);
• Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrolment;
• Known or suspected brain metastasis or active leptomeningeal disease;
• History of another malignancy within the previous 5 years other than curatively treated non melanomatous skin cancer;
• Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2.5 times the upper limit of normal at the Screening visit;
• Creatinine \> 177 µmol/L (2 mg/dL) at the Screening visit;
• Hemoglobin \<6 mmol/L, White blood cells \< 4.0 x 10\^9/L, Platelets \< 100 x 10\^9/L;
• History of seizure or any condition that may predispose to seizure. Also, history of loss of consciousness or transient ischemic attack within 12 months of enrolment (Day 1 visit);
• Contra-indication for MRI (e.g. pacemaker).

Sponsors & Collaborators

• The European Uro-Oncology Group: lead
• Centre for Human Drug Research, Netherlands: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Related Links

• The European Uro-Oncology Group

MeSH Terms

Interventions

enzalutamide

Study Officials

• Susanne Osanto, MD PhD

  The European Uro-Oncology Group (EUOG)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2016
• First Posted: June 28, 2016
• Study Start: July 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 14, 2022

Record last verified: 2021-02

Locations

NL (1)