|- candidate number||15174|
|- NTR Number||NTR4086|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-jul-2013|
|- Secondary IDs||FuTuRe |
|- Public Title||Evaluation of 18F-FDHT PET/CT as an early treatment response marker in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide|
|- Scientific Title||Evaluation of 18F-FDHT PET/CT as an early treatment response marker in patients with metastasized castration-resistant prostate cancer to be treated with enzalutamide|
|- hypothesis||18F-FDHT PET/CT is excpected to be an early treatment response marker in patients with metastasized castration-resistant prostate cancer who are to be treated with enzalutamide|
|- Healt Condition(s) or Problem(s) studied||Castration-resistant prostate cancer|
|- Inclusion criteria||Main inclusion criteria:|
1. Age 50 or older.
2. Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
3. Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone analogue or bilateral orchidectomy.
4. Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bone disease.
5. Metastatic disease documented by bone lesions on bone scan or by measurable soft tissue disease by CT
6. No prior cytotoxic chemotherapy for prostate cancer.
7. Asymptomatic or mildly symptomatic from prostate cancer.
8. Written informed consent.
|- Exclusion criteria||Main exclusion criteria:|
1. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.
2. Known or suspected brain metastasis or active leptomeningeal disease.
3. History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2013|
|- planned closingdate||1-dec-2019|
|- Target number of participants||60|
|- Interventions||Treatment / intervention = enzalutamide. Patients will be scanned prior to treatment and after 4 weeks of treatment. Scan results will subsequently be associated with treatment response.There is no control group. Enzalutamide should be continued as long as the patient is tolerating the study drug and continues androgen deprivation therapy, up to judgement by the primary investigator.|
|- Primary outcome||Primary end points of the primairy objective: |
Association of 18F-FDHT PET/CT at baseline (study week 1) with treatment response.
Association of delta (study week 1 – week 5) 18F-FDHT PET/CT with treatment response.
|- Secondary outcome||Secondary end points of the primairy objective: |
Association of 18F-FDHT PET/CT at baseline (study week 1) with progressive disease.
Association of delta (study week 1 – week 5) 18F-FDHT PET/CT with progressive disease.
|- Timepoints||See above|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. I.J. Jong, de|
|- CONTACT for SCIENTIFIC QUERIES||Dr. I.J. Jong, de|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Center for Translational Molecular Medicine (CTMM)|
|- Brief summary||Worldwide prostate cancer is the second most frequently diagnosed cancer in men. While localized prostate cancer can be treated with curative intent, metastasized prostate cancer has palliative treatment options only. Endocrine deprivation therapy is the mainstay of treatment for patients with metastasized prostate cancer. In the end, prostate cancer progresses in the majority of patients because of progressive tumor growth despite endocrine deprivation therapy: castration-resistant prostate cancer (CRPC). As CRPC progresses, approximately 90% of patients will develop bone metastases, in contrast to lymph node metastases which develop in 20% to 25% of patients. The determination of response to treatment in patients with CRPC is predominantly plagued by the presence of non-measurable bone metastases. Positron Emission Tomography (PET) is emerging as a promising imaging modality to evaluate treatment options and therapeutic response timely, objectively and quantitatively. 16β-[18F]-fluoro-5α-dihydrotestosterone (18F-FDHT) images the androgen receptor with high binding affinity and selectivity. It is expected that 18F-FDHTPET/CT can give an indication of success or failure early in the treatment course as part of clinical management or within the context of clinical trials. Timely response management may adjust the duration of individual treatment according to its success. This is where the FuTuRe trial comes in. The primary objective is to evaluate 18F-FDHT PET/CT as an early treatment response marker in patients with CRPC who are to be treated with enzalutamide.|
|- Main changes (audit trail)|
|- RECORD||23-jul-2013 - 4-aug-2013|