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The effect of androgen deprivation therapy on the expression of prostate specific membrane antigen (PSMA) in treatment naive metastatic prostate cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519516-14-01
Enrollment
35
Registered
2025-01-28
Start date
2019-04-15
Completion date
Unknown
Last updated
2025-01-28

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

Conditions

Metastatic prostate cancer, Prostate cancer

Brief summary

To demonstrate that PSMA-flare seen 2-3weeks after initiation of ADT at baseline is more common in bony lesions than in prostatic lesions

Detailed description

To study if metastatic lesions with and without PSMA-flare seen in baseline behave differently in repeated 18F-PSMA-PET CT at the time of CRPC, To compare the metastatic load seen in 18F-PSMA-PET CT and FDGPET- CT at baseline (Sub-study 1), To determine the total androgen profile during the evolution of metastatic Pca by repeated total androgen measurements in every six months from diagnosis to the development of CRPC (Sub-study 2), To biopsy prostate lesions seen on 18F-PSMA PET and determine if the changes of PSMA uptake after ADT might have a histopathological correlation (Substudy 3), To investigate gut microbiome and its changes during ADT (Substudy 4)

Interventions

DRUGDEGARELIX

Sponsors

Turku University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
To demonstrate that PSMA-flare seen 2-3weeks after initiation of ADT at baseline is more common in bony lesions than in prostatic lesions

Secondary

MeasureTime frame
To study if metastatic lesions with and without PSMA-flare seen in baseline behave differently in repeated 18F-PSMA-PET CT at the time of CRPC, To compare the metastatic load seen in 18F-PSMA-PET CT and FDGPET- CT at baseline (Sub-study 1), To determine the total androgen profile during the evolution of metastatic Pca by repeated total androgen measurements in every six months from diagnosis to the development of CRPC (Sub-study 2), To biopsy prostate lesions seen on 18F-PSMA PET and determine if the changes of PSMA uptake after ADT might have a histopathological correlation (Substudy 3), To investigate gut microbiome and its changes during ADT (Substudy 4)

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026