NCT03938766

Brief Summary

Prostate specific membrane antigen (PSMA) is a unique membrane bound glycoprotein, which is overexpressed on prostate cancer cells and is well-characterized as an imaging biomarker of prostate cancer. Studies have shown that PSMA PET/CT can detect prostate cancer lesions with excellent contrast and a high detection rate even when the level of prostate specific antigen is low. PSMA imaging is considered the gold standard in imaging of biochemical recurrence, with detection rate of recurrence in 79.5% of patients, in the largest series of 1007 patients. Despite these excellent results, there remains approximately 20% of patients in whom the site of biochemical recurrence cannot be identified and further research is needed into improving detection rates. Androgen deprivation therapy (ADT), represents the standard of care treatment for most men with a rising serum PSA and no evidence of disseminated disease on imaging modalities. There has been some preliminary data that imaging patients early after initiation of ADT therapy may increase detection rates of recurrence sites. The objective of this study is to evaluate if prostate cancer patients with biochemical recurrence and negative PSMA PET/CT can demonstrate in-vivo upregulation of PSMA receptors in an attempt to improve detection rates of recurrent prostate cancer. Patients who are started on ADT when clinically indicated, will have repeat PSMA PET/CT at 4 weeks following initiation of ADT therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

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

February 2, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

May 2, 2019

Last Update Submit

February 11, 2020

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Detection rates of recurrence

    The percentage of 18F-DCFPyL PET/CT positive for identification of biochemical recurrence sites in patients with prostate cancer following initiation of ADT therapy.

    2 years

Study Arms (1)

PSMA PET/CT

OTHER

Repeat PSMA PET/CT after ADT

Diagnostic Test: PSMA PET/CT

Interventions

PSMA PET/CTDIAGNOSTIC_TEST

Repeat PSMA PET/CT 4 weeks post initiation of clinically indicated ADT in patients with prior negative PSMA PET/CT performed for biochemical recurrence.

PSMA PET/CT

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male sex
  • Age 18 years or older
  • Previous diagnosis of prostate cancer following radical prostatectomy or primary radiation therapy, with biochemical recurrence.
  • Prior negative PSMA PET/CT within 2 months prior to study entry
  • ECOG performance status 0 - 3, inclusive
  • Able to understand and provide written informed consent
  • Initiation of androgen deprivation therapy within 5 weeks prior to study PSMA PET/CT
  • Able to tolerate the physical/logistical requirements of a PET/CT scan

You may not qualify if:

  • Medically unstable patients
  • Patients who exceed the safe weight limit of the PET/CT bed (200 kg) or who cannot fit through the PET/CT bore (70 cm diameter)
  • Patients with unmanageable claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H4R3E8, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 6, 2019

Study Start

February 2, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)