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Detection and staging of bone metastases in prostate cancer, not yet been treated with hormones, using labelled testosterone in PET/CT.

[18F]-labelled FDHT in PET/CT for detection and staging of bone metastases in hormone naïve prostate cancer - [18F]FDHT PET in hormone naive prostate cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-002415-10-NL
Enrollment
Unknown
Registered
2013-06-19
Start date
2014-02-11
Completion date
Unknown
Last updated
2014-03-10

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

Conditions

Hormone naive prostate cancer, metastasized to bone (2 or more bone metastases).

Interventions

Product Name: [18F]-FDHT Pharmaceutical Form: Radiopharmaceutical precursor, solution INN or Proposed INN: 16ß-[18F]fluoro-5a-dihydrotestosterone CAS Number: 142713-31-3 Concentration unit: MBq megabe

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: • metastasized prostate cancer, =2 lesions in bone, onfirmed by visible lesions on bone scan, CT and/or MRI consistent with disease • no other known malignancies • no previous androgen deprivation therapy • informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: • active cancer besides prostate cancer • previous androgen deprivation therapy • no informed consent • imminent pathological fractures or spinal cord lesions as a result of metastases that require immediate start of androgen deprivation therapy

Design outcomes

Primary

MeasureTime frame
Secondary Objective: The secondary objective is to determine differences in uptake in lesions using [18F]FDHT PET/CT three months after start of androgen deprivation therapy. Also if there is relation between uptake in lesions and Glasgow Sum Score and PSA (both routinely obtained);Primary end point(s): Second [18F]-FDHT PET.;Timepoint(s) of evaluation of this end point: 3 months after first [18F]-FDHT PET (approximately 4 months after inclusion).;Main Objective: The primary objective of this study is to determine the feasibility of [18F]FDHT PET/CT for in vivo evaluation of bone metastases in prostate cancer. Active locations will be compared with those seen on conventional imaging (bone scintigraphy, CT and/or MRI)—

Secondary

MeasureTime frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.—

Countries

Netherlands

Contacts

Public ContactR.J. Dost

University Medical Center Groningen

rj.dost@umcg.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026