NCT03313726

Brief 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.

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
30

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2017

Shorter than P25 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

September 20, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 18, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

October 9, 2017

Last Update Submit

October 13, 2017

Conditions

Prostate Cancer

Keywords

PSMA-PET

Outcome Measures

Primary Outcomes (2)

  • GnRh-antagonist, A

    Maximum SUV in PSMA-PET

    0, 7, 14 and 28 days after ADT initiation

  • GnRh-antagonist, B

    Sensitivity and specificity of pre and post ADT 68Ga-PSMA-11 PET/MRI and standard clinical MRI using histology as a reference

    0 and 7, 14 or 28 days after ADT initiation according to phase A

Secondary Outcomes (4)

  • GnRh-antagonist, A

    0, 7, 14 and 28 days after ADT initiation

  • GnRh-antagonist, A

    0, 7, 14 and 28 days after ADT initiation

  • GnRh-antagonist, B

    56 and 112 days after ADT initiation

  • GnRh-antagonist, B

    56 and 112 days after ADT initiation

Study Arms (2)

GnRh-antagonist A

EXPERIMENTAL
Drug: GnRH antagonist

GnRh-antagonist B

EXPERIMENTAL
Drug: GnRH antagonist

Interventions

GnRH antagonistDRUG

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.

GnRh-antagonist A

Eligibility Criteria

Age40 Years - 85 Years
Sexmale
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-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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku University Hospital

Turku, 20520, Finland

RECRUITING

Related Publications (1)

  • Ettala 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: 31879814DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jukka Kemppainen, MD, PhD

CONTACT

+358-2-3130196jukka.kemppainen@tyks.fi

Otto Ettala, MD, PhD

CONTACT

+358-2-3130280otto.ettala@tyks.fi

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2017

First Posted

October 18, 2017

Study Start

September 20, 2017

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

October 18, 2017

Record last verified: 2017-10

Locations

FI(1)