Clinical trial · Interventional
The Effect of ADT on PSMA-PET.
The Effect of Androgen Deprivation Therapy on Prostate Specific Membrane Antigen (PSMA) in Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Phase A: To describe and to determine the maximum standardised uptake values (SUV) in prostate specific membrane antigen positron emission tomography (PSMA-PET) before ADT and 7, 14 and 28 days after ADT. Phase B: To validate phase A results by comparing the PSMA-PET findings to histopathological analysis of regional lymph nodes acquired from radical prostatectomy specimens. PSMA-PET is done before ADT and at maximum SUV defined by the phase A.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GnRH antagonist | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GnRh-antagonist A
- interventionNames
- Drug: GnRH antagonist
- type
- EXPERIMENTAL
- label
- GnRh-antagonist B
- interventionNames
- Drug: GnRH antagonist
Primary outcomes (2)
- measure
- GnRh-antagonist, A
- timeFrame
- 0, 7, 14 and 28 days after ADT initiation
- description
- Maximum SUV in PSMA-PET
- measure
- GnRh-antagonist, B
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 40 to 85 years old * Language spoken: Finnish * Diagnosis: Histologically confirmed adenocarcinoma of prostate * Adequate histological sampling consisting of at least 3 biopsy samples from each lobe * No previous surgical, radiation or endocrine treatment for prostate carcinoma * Clinical stage: T1c-T4N0-2M0-1 (arm, A); T1c-T3NxMx (arm, B) * Serum creatinine ≤ 1,5 x ULN * Patient agrees to undergo surgery (arm, B) * Mental status: Patients must be able to understand the meaning of the study * Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff Exclusion Criteria: * Infections: Patient must not have an uncontrolled serious infection * contraindications for MRI (cardiac pacemaker, intracranial clips etc) * Prior usage of 5-ARI medication in past 12 months * Patient preference for active surveillance as a method of prostate cancer management
References
Publications (1)
- DERIVEDEttala O, Malaspina S, Tuokkola T, Luoto P, Loyttyniemi E, Bostrom PJ, Kemppainen J. Prospective study on the effect of short-term androgen deprivation therapy on PSMA uptake evaluated with 68Ga-PSMA-11 PET/MRI in men with treatment-naive prostate cancer. Eur J Nucl Med Mol Imaging. 2020 Mar;47(3):665-673. doi: 10.1007/s00259-019-04635-7. Epub 2019 Dec 26. PMID 31879814