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Trial record 76 of 106 for:    "Kennedy disease"

18F-FDG PET/CT and Whole Body MRI for Staging and Response Prediction in Castration-resistant Prostate Cancer Patients Receiving Enzalutamide

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ClinicalTrials.gov Identifier: NCT02814968
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Centre for Human Drug Research, Netherlands
Information provided by (Responsible Party):
The European Uro-Oncology Group

Brief Summary:

The aim of the study is to assess the clinical utility of 18F-fluoro-deoxyglucose Positron Emission Tomography (PET)/Computed Tomography (CT) and Whole Body Magnetic Resonance Imaging (MRI) versus conventional bone scan and prostate-specific antigen (PSA) measurements in response prediction to treatment with Enzalutamide in castration-resistant 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 castration-resistant prostate cancer patients.

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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Metastatic Drug: Enzalutamide Device: 18-FDG PET/CT Device: Whole body MRI Device: Bone scan Phase 2

Detailed Description:

Castration-resistant prostate cancer patients eligible for 2nd 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 18F-FDG PET/CT scans at baseline, 2 weeks, 2 and 6, 9 and 12 months after starting androgen receptor-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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Phase 2, Open-label, Single-arm, Efficacy and Imaging Study of Oral Enzalutamide (XTANDI) Androgen Receptor-Directed Therapy in Chemo-Naïve Patients With Progressive Prostate Cancer Who Have Failed Androgen Deprivation Therapy (Castration-resistant Prostate Cancer Patients)
Study Start Date : February 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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
Device: 18-FDG PET/CT
Device: Whole body MRI
Device: Bone scan



Primary Outcome Measures :
  1. Progression-Free Survival (PFS) at 6 months [ Time Frame: 6 months ]

    Defined as the time from the date of randomization to the date of radiological progression or death (patients will be followed beyond the fixed time point of 12 months for continued response cq recurrence, but 12 month is the last fixed primary endpoint assessment). Radiological progression is defined by any of the following criteria:

    • Soft tissue lesions: Progressive disease on 18F-FDG PET/CT or 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 18F-FDG 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 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).

  2. Progression-Free Survival (PFS) at 12 months [ Time Frame: 12 months ]

    Defined as the time from the date of randomization to the date of radiological progression or death (patients will be followed beyond the fixed time point of 12 months for continued response cq recurrence, but 12 month is the last fixed primary endpoint assessment). Radiological progression is defined by any of the following criteria:

    • Soft tissue lesions: Progressive disease on 18F-FDG PET/CT or 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 18F-FDG 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 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).


Secondary Outcome Measures :
  1. Biochemical (PSA) response defined as prostate-specific antigen (PSA) nadir. [ Time Frame: 12 months ]
  2. PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements). [ Time Frame: 12 months ]
  3. Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria. [ Time Frame: 6 and 12 months ]
  4. Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression. [ Time Frame: 6 and 12 months ]
  5. Occurrence of Symptomatic Skeletal Events (SSE) evaluated by combination of clinical and radiological assessments [ Time Frame: 12 months ]
    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

  6. Number of participants with change in CTC measurements correlated to radiological PFS. [ Time Frame: 6 and 12 months ]
  7. Percent change from baseline in serum concentration of circulating testosterone (T). [ Time Frame: 12 months ]
  8. Percent change from baseline in serum concentration of dihydrotestosterone (DHT). [ Time Frame: 12 months ]
  9. Percent change from baseline in serum concentration of sex hormone binding globulin (SHBG). [ Time Frame: 12 months ]
  10. Percent change from baseline in serum concentration of androstenedione (A). [ Time Frame: 12 months ]
  11. Number of participants with 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. [ Time Frame: 6 and 12 months ]
  13. Time to symptomatic progression (including death due to prostate cancer). [ Time Frame: 12 months ]
  14. 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 Frame: 12 months ]
  16. Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. [ Time Frame: 6 and 12 months ]
  17. Quality of life measured by the EuroQol 5-Dimension QoL Instrument (EQ-5D). [ Time Frame: 6 and 12 months ]
  18. Changes in Karnofsky score [ Time Frame: 6 and 12 months ]
  19. Changes in visual analogue scale (VAS) for tumour-related pain. [ Time Frame: 6 and 12 months ]
  20. Changes in bone mineral density (BMD) as measured by Dual-energy X-ray absorptiometry (DXA) scan. [ Time Frame: 6 and 12 months ]
  21. Cost-effectiveness of 18F-FDG PET/CT and Whole Body MRI compared to conventional prostate cancer staging. [ Time Frame: 6 and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male aged 18 years or older;
  • Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features;
  • Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy;
  • Three consecutive rises of PSA, 1 week apart, resulting in two 50% increases over the nadir, with PSA of at least > 5 ng/mL but preferably >10 ng/mL;
  • Progressive disease as defined by rising PSA levels plus by evidence of progressive and measurable soft tissue or bone disease by 18F-FDG PET/CT, Whole Body MRI or both;
  • Castrate serum levels of testosterone < 50 ng/dL or < 1.7 nmol/L;
  • Anti-androgen withdrawal for at least 6 weeks for bicalutamide, nilutamide or flutamide for at least 6 weeks;
  • 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:

  • 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 x10^9/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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02814968


Contacts
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Contact: Jetty Hagen + 31 (0) 5264109 EUOG@lumc.nl

Locations
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Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Susanne Osanto, MD PhD    +31 (0) 71 526 3464    s.osanto@lumc.nl   
Principal Investigator: Susanne Osanto, MD PhD         
Sponsors and Collaborators
The European Uro-Oncology Group
Centre for Human Drug Research, Netherlands
Investigators
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Study Chair: Susanne Osanto, MD PhD The European Uro-Oncology Group (EUOG)

Additional Information:
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Responsible Party: The European Uro-Oncology Group
ClinicalTrials.gov Identifier: NCT02814968     History of Changes
Other Study ID Numbers: EudraCT Number 2014-001161-27
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Keywords provided by The European Uro-Oncology Group:
Castration-resistant prostate cancer
Enzalutamide
Imaging
PET/CT
Whole body MRI
Circulating tumour cells
Cell-free tumour DNA
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases