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CompletedNCT02815033Updated Apr 14, 2022

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

A Phase 2 interventional study of Enzalutamide and 11C or 18F-Choline PET/CT in Prostate Cancer Metastatic, sponsored by The European Uro-Oncology Group. Completed at 1 site in Netherlands. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-14.

Sponsored by The European Uro-Oncology Group · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the detailed description

Metastatic prostate cancer patients eligible for 1st line hormonal treatment will undergo treatment with Enzalutamide (XTANDI). Subjects will receive 1dd 160 mg Enzalutamide orally continuously until progressive disease occurs. All subjects will undergo Choline (11C or 18F)-PET/CT scans at baseline, 2 weeks, 2 and 6, 9 and 12 months after starting androgen receptor (AR)-directed treatment. All subjects will undergo Whole Body MRI at baseline, 6, 9 and 12 months. Bone scans will be performed at baseline, 3 months, 6 and 12 months. PSA will be measured at baseline and every 4 weeks thereafter until at 12 months. CTC counts and characteristics will be measured at baseline and during Enzalutamide treatment.

02

Conditions studied

  • Prostate Cancer Metastatic

Keywords

  • Hormono-Sensitive prostate cancer
  • Enzalutamide
  • Imaging
  • PET/CT
  • Whole body MRI
  • Circulating tumour cells
  • Cell-free tumour DNA
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 66 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

The European Uro-Oncology Group is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Other
    Single arm

    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

  • DrugEnzalutamide

    Also known as: Xtandi

  • Procedure11C or 18F-Choline PET/CT
  • ProcedureWhole body MRI
  • ProcedureBone scan
06

What researchers measure

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).

    Time frame: 6 and 12 months

Secondary outcomes

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

    Assessment of nadir PSA

    Time frame: 12 months

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

    PSA doubling time

    Time frame: 12 months

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

    Bone lesions progression

    Time frame: 6 and 12 months

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

    Assessment of spinal cord compression or pathological fracture

    Time frame: 6 and 12 months

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

    SSE is defined as external beam radiation therapy to relieve skeletal pain, occurrence of a new symptomatic pathologic bone fracture, spinal cord compression, tumour-related orthopedic surgical intervention or change of anti-neoplastic therapy to treat bone pain

    Time frame: 12 months

  6. Circulating tumour cell (CTC) measurements and comparison with radiological PFS at 6 and 12 months

    Assessment of CTC

    Time frame: 6 and 12 months

  7. Percent change from baseline in serum concentration of circulating testosterone (T)

    Changes in testosterone from baseline

    Time frame: 12 months

  8. Percent change from baseline in serum concentration of dihydrotestosterone (DHT)

    Changes in dihydrotestosterone from baseline

    Time frame: 12 months

  9. Percent change from baseline in serum concentration of sex hormone binding globulin (SHBG)

    Changes in sex hormone binding globulin

    Time frame: 12 months

  10. Percent change from baseline in serum concentration of androstenedione (A)

    Changes in androstenedione from baseline

    Time frame: 12 months

  11. Number of participants with changes in biomarkers of bone turnover correlated to PSA

    Changes in biomarkers of bone turnover correlated to PSA

    Time frame: 12 months

  12. Number of participants with adverse events (AEs) and serious adverse events (SAEs) leading to treatment discontinuation

    Assessment of AE and SAEs

    Time frame: 6 and 12 months

  13. Time to symptomatic progression (including death due to prostate cancer)

    Time to progression

    Time frame: 12 months

  14. Time to first radiological or symptomatic progression

    Time to first radiological or symptomatic progression

    Time frame: 6 and 12 months

  15. Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation

    Time to chemotherapy or palliative radiation

    Time frame: 12 months

  16. Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire

    Quality of Life measurement using questionnaires

    Time frame: 6 and 12 months

  17. Quality of life measured by the EuroQol 5-Dimension QoL Instrument (EQ-5D)

    Quality of life measurement using questionnaire

    Time frame: 6 and 12 months

  18. Changes in Sexual Function (IIEF)

    Changes in Sexual Function from baseline

    Time frame: 6 and 12 months

  19. Changes in Karnofsky score

    Changes in Karnofsky score from baseline

    Time frame: 6 and 12 months

  20. Changes in visual analogue scale (VAS) for tumour-related pain

    Changes in pain from baseline

    Time frame: 6 and 12 months

  21. Changes in bone mineral density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA) scan

    Changes in bone mineral density from baseline

    Time frame: 6 and 12 months

07

Study locations

1 site
  • Leiden University Medical Center
    Leiden, 2333 ZA, Netherlands
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02815033
Lead sponsor
The European Uro-Oncology Group
Collaborators
Centre for Human Drug Research, Netherlands
Responsible party
Sponsor
First posted
Jun 28, 2016
Start date
Jul 2015
Primary completion
Jun 2020
Completion
Dec 2020
Last update
Apr 14, 2022

Study contacts

Susanne Osanto, MD PhD
study chair · The European Uro-Oncology Group (EUOG)
View the source record on ClinicalTrials.gov ↗

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