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Prostate Cancer MetastaticPhase 2NCT02815033

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

A Phase 2 study testing Enzalutamide, 11C or 18F-Choline PET/CT and Whole body MRI in people with Prostate Cancer Metastatic, run by The European Uro-Oncology Group at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic
What is being tested?
Enzalutamide, 11C or 18F-Choline PET/CT and Whole body MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteNetherlands
Study dates
Jul 2015to Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
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  • 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).

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Leiden University Medical Center

    Leiden, 2333 ZA

Other trials in Netherlands

About this study

Official title: An Exploratory Phase 2, Open-label, Single-arm, Efficacy and Imaging Study of Oral Enzalutamide (XTANDI) Androgen Receptor (AR)-Directed Therapy in Hormono-Sensitive Patients With Metastatic Prostate Cancer (Hormono-sensitive Patients)

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.

Being tested
Enzalutamide, 11C or 18F-Choline PET/CT, Whole body MRI, Bone scan
Keywords
Hormono-Sensitive prostate cancer, Enzalutamide, Imaging, PET/CT, Whole body MRI, Circulating tumour cells, Cell-free tumour DNA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called Xtandi

  • 11C or 18F-Choline PET/CTProcedure or surgery

  • Whole body MRIProcedure or surgery

  • Bone scanProcedure or surgery

Study groups in NCT02815033
Study groupRoleWhat they receive
Single armOtherExperimental: 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.
Receives: Drug: Enzalutamide; Procedure: 11C or 18F-Choline PET/CT; Procedure: Whole body MRI; Procedure: Bone scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 and 12 months

Secondary outcomes (21)

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

    Assessment of nadir PSA

    Measured: 12 months

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

    PSA doubling time

    Measured: 12 months

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

    Bone lesions progression

    Measured: 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

    Measured: 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

    Measured: 12 months

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

    Assessment of CTC

    Measured: 6 and 12 months

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

    Changes in testosterone from baseline

    Measured: 12 months

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

    Changes in dihydrotestosterone from baseline

    Measured: 12 months

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

    Changes in sex hormone binding globulin

    Measured: 12 months

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

    Changes in androstenedione from baseline

    Measured: 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

    Measured: 12 months

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

    Assessment of AE and SAEs

    Measured: 6 and 12 months

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

    Time to progression

    Measured: 12 months

  14. Time to first radiological or symptomatic progression

    Time to first radiological or symptomatic progression

    Measured: 6 and 12 months

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

    Time to chemotherapy or palliative radiation

    Measured: 12 months

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

    Quality of Life measurement using questionnaires

    Measured: 6 and 12 months

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

    Quality of life measurement using questionnaire

    Measured: 6 and 12 months

  18. Changes in Sexual Function (IIEF)

    Changes in Sexual Function from baseline

    Measured: 6 and 12 months

  19. Changes in Karnofsky score

    Changes in Karnofsky score from baseline

    Measured: 6 and 12 months

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

    Changes in pain from baseline

    Measured: 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

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2016 (estimated)
  2. Study startJul 2015
  3. Primary completionJun 2020
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02815033
Sponsor's protocol ID
EudraCT Number: 2014-001162-10
Status last verified
Feb 2021
First submitted
18 Jun 2016
Last updated
14 Apr 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Enzalutamide, 11C or 18F-Choline PET/CT and Whole body MRI in people with Prostate Cancer Metastatic, run by The European Uro-Oncology Group at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) at 6 and 12 months. (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02815033.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.

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