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 Chemo-Naïve patients with Progressive Prostate Cancer who have failed Androgen Deprivation Therapy (CRPC patients) - Xtandi in Chemo-Naïve CRPC patients failing Androgen Deprivation Therapy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45038

Enrollment

Registered

2015-03-30

Start date

2015-06-25

Completion date

Unknown

Last updated

2024-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic prostate cancer

Interventions

Oral Enzalutamide

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult metastatic prostate cancer patients who are progressive on first-line ADT for metastatic disease and who have at least one measurable metastasis on either 18F-FDG PET/CT or WB MRI or both.

Exclusion criteria

Exclusion criteria: Previous chemotherapy, impaired liver/kidney/bone marrow function, susceptibility for seizures

Design outcomes

Primary

Measure	Time frame
Progression-Free Survival (PFS) at 6 and 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*s 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 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).	—

Measure

Time frame

Progression-Free Survival (PFS) at 6 and 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*s 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 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).

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Secondary

Measure	Time frame
Biochemical (PSA) response defined as prostate-specific antigen (PSA) nadir. PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements). Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria. Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression. A Symptomatic Skeletal Event (SSE) is defined as external beam radiation therapy (EBRT) to relieve skeletal pain, new symptomatic pathologic bone fracture, occurrence of spinal cord compression or tumour-related orthopedic surgical intervention, or change of anti-neoplastic therapy to treat bone pain. CTC measurements and comparison with radiological PFS at 6 and 12 months. Circulating testosterone (T), dihydrotestosterone (DHT), sex hormone binding globulin (SHBG), androstenedione, DHEA, luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin and estradiol assessed as temporal changes of absolute values and temporal percentage changes of baseline values. Biomarker assessment / correlative: (next to PSA) biomarkers of bone turnover, Alkaline Phosphatase, PTH, Ca, Phosphate, 25 (OH)Vitamin D, beta-CTX (beta-crosslaps), PN1P. The safety of Enzalutamide as assessed by serious adverse events (SAEs), severity of adverse events (AEs) graded by National Cancer Institute*s Common Terminology Criteria for Adverse Events (NCI-CTCAE), discontinuation due to AEs, as well as new clinically significant changes in physical exam findings, vital signs, laboratory values, and ECGs. Time to symptomatic progression (including death due to prostate cancer) Time to first radiological or symptomatic progression Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and by the EuroQol 5-Dimension QoL Instrument (EQ-5D) Change	—

Measure

Time frame

Biochemical (PSA) response defined as prostate-specific antigen (PSA) nadir. PSA progression. PSA kinetics measured by PSA doubling time (regular PSA measurements). Progression of bone lesions detected with bone scan according to Prostate Cancer Working Group 2 (PCWG2) criteria. Radiologically confirmed spinal cord compression or pathological fracture due to malignant progression. A Symptomatic Skeletal Event (SSE) is defined as external beam radiation therapy (EBRT) to relieve skeletal pain, new symptomatic pathologic bone fracture, occurrence of spinal cord compression or tumour-related orthopedic surgical intervention, or change of anti-neoplastic therapy to treat bone pain. CTC measurements and comparison with radiological PFS at 6 and 12 months. Circulating testosterone (T), dihydrotestosterone (DHT), sex hormone binding globulin (SHBG), androstenedione, DHEA, luteinizing hormone (LH), follicle stimulating hormone (FSH), prolactin and estradiol assessed as temporal changes of absolute values and temporal percentage changes of baseline values. Biomarker assessment / correlative: (next to PSA) biomarkers of bone turnover, Alkaline Phosphatase, PTH, Ca, Phosphate, 25 (OH)Vitamin D, beta-CTX (beta-crosslaps), PN1P. The safety of Enzalutamide as assessed by serious adverse events (SAEs), severity of adverse events (AEs) graded by National Cancer Institute*s Common Terminology Criteria for Adverse Events (NCI-CTCAE), discontinuation due to AEs, as well as new clinically significant changes in physical exam findings, vital signs, laboratory values, and ECGs. Time to symptomatic progression (including death due to prostate cancer) Time to first radiological or symptomatic progression Time to initiation of salvage systemic therapy, including chemotherapy, or palliative radiation Quality of life measured by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire and by the EuroQol 5-Dimension QoL Instrument (EQ-5D) Change

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Countries

Netherlands, Switzerland

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)