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The Effect of ADT on PSMA-PET.

NCT03313726 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-10-18

No results posted yet for this study

Summary

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

Interventions

DRUG

GnRH antagonist

Administration of GnRh antagonist after baseline PSMA-PET at day 0 and then repeated PSMA-PET scans at day 7, day 14 and day 28 to define the timeframe of the SUV-max.

DRUG

GnRH antagonist

Administration of GnRh-antagonist after baseline PSMA-PET at day 0 and then repeated scan at day in which SUV-max was observed in the Arm A (day 7, day 14 or day 28). Then robot assisted radical prostatectomy and lymphadenectomy are performed to verify the finding.

Sponsors & Collaborators

  • Turku University Hospital

    lead OTHER_GOV

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-20
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Finland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03313726 on ClinicalTrials.gov