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Het vaststellen van botmetastases in hormoon naïeve prostaatkanker in PET/CT met behulp van [18F]FDHT


- candidate number15162
- NTR NumberNTR4083
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jul-2013
- Secondary IDs2013-002415-10 EudraCTnr
- Public TitleHet vaststellen van botmetastases in hormoon naïeve prostaatkanker in PET/CT met behulp van [18F]FDHT
- Scientific Title[18F] -labelled FDHT in PET/CT for detection and staging of bone metastases in hormone naïve prostate cancer
- ACRONYMPROCoMBO
- hypothesis
- Healt Condition(s) or Problem(s) studiedHormone naive prostate cancer metastasized to bone,
- Inclusion criteria• metastasized prostate cancer, ≥2 lesions in bone, confirmed by
o visible lesions on bone scan, CT and/or MRI consistent with disease
o age ≥ 50 years
• no other known malignancies
• written informed consent
• no previous androgen deprivation therapy
- Exclusion criteria• active cancer besides prostate cancer
• age < 50 years
• no written informed consent
• previous androgen deprivation therapy
• imminent pathological fractures or spinal cord lesions as a result of metastases that require immediate start of androgen deprivation therapy
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2013
- planned closingdate1-sep-2015
- Target number of participants0
- Interventions[18F]FDHT in PET/CT
- Primary outcomePatients with metastasized prostate cancer will undergo a [18F]FDHT PET/CT before start of ADT. A second scan will be performed three months after start of ADT. Primary outcome is the amount of decreased uptake of 18F-FDHT per lesions before and after three months of ADT.
- Secondary outcomeN/A
- TimepointsPrimary outcome will be measured after the second [18F]FDHT PET/CT. (3 mo’s after start of ADT).
- Trial web siteN/A
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIES R.J. Dost
- CONTACT for SCIENTIFIC QUERIES R.J. Dost
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Government funding, Philips, IQ Therapeutics, Astellas Pharma B.V, NovioGendix Research, Dionex Benelux
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD19-jul-2013 - 8-aug-2013


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