NCT03876912

Brief Summary

Thirty-five men with newly diagnosed, metastatic prostate cancer are scanned with 18F-PSMA 1007 PET/CT at baseline, 3 weeks after the initiation of GnRH-antagonist, at one year and at the time of castration resistant prostate cancer (CRPC). The aim of the study is to classify metastatic lesions into those with PSMA-flare and those without and determine their potential to progress during the follow-up until CRPC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

March 14, 2019

Last Update Submit

April 8, 2021

Conditions

Prostate Cancer

Keywords

Prostate Specific Membrane AntigenGnRH antagonistPositron Emission TomographyPSMA-PET/CT

Outcome Measures

Primary Outcomes (1)

  • PSMA-flare after ADT

    Comparison of mean increase of SUVmax in 18F-PSMA 1007 PET between bone lesions and prostatic lesions after the initiation of ADT

    2-3 weeks

Secondary Outcomes (1)

  • PSMA-flare in the follow-up until CRPC

    2-3 years

Study Arms (1)

GnRH antagonist

EXPERIMENTAL

Administration of GnRH antagonist (subcutaneous injection, 240 mg) after baseline 18F-PSMA 1007 PET/CT.Then 18F-PSMA 1007 PET/CT is repeated 3 weeks after ADT and at development of CRPC

Drug: GnRH antagonist

Interventions

GnRH antagonistDRUG

18F-PSMA 1007 PET/CT before, 3 weeks after ADT, at 1 year and at CRPC in 35 patients. 18F-FDG PET/CT in a subgroup of 20 patients before ADT.

Also known as: Degarelix
GnRH antagonist

Eligibility Criteria

Age40 Years - 85 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsProstate cancer patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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-T4NanyM1
  • Serum creatinine ≤ 1,5 x ULN
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethical Committee approved informed consent documents in the presence of the designated staff

You may not qualify if:

  • Previous PC treatment
  • Uncontrolled serious infection
  • Prior usage of 5-ARI medication in past 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20500, Finland

RECRUITING

Related Publications (1)

  • Malaspina S, Ettala O, Tolvanen T, Rajander J, Eskola O, Bostrom PJ, Kemppainen J. Flare on [18F]PSMA-1007 PET/CT after short-term androgen deprivation therapy and its correlation to FDG uptake: possible marker of tumor aggressiveness in treatment-naive metastatic prostate cancer patients. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):613-621. doi: 10.1007/s00259-022-05970-y. Epub 2022 Sep 26.

    PMID: 36161511DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jukka Kemppainen, Adj.Prof.

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Simona Malaspina, MD

CONTACT

+35823138122simona.malaspina@tyks.fi

Otto Ettala, PhD

CONTACT

+35823130280otto.ettala@tyks.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 15, 2019

Study Start

March 1, 2019

Primary Completion

September 1, 2021

Study Completion

March 1, 2023

Last Updated

April 13, 2021

Record last verified: 2021-04

Locations

FI(1)