NCT03768349

Brief Summary

Imaging and staging of prostate cancer is critical for surgical and treatment planning. In this protocol we will image patients with suspected metastatic prostate cancer using 11C-Choline PET and Gallium-68 labeled HBED-CC PSMA (more commonly called 68Ga-PSMA-11) or F-18 labeled PSMA 1007 in order to demonstrate their utility in detecting prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for early_phase_1 prostate-cancer

Timeline
Completed

Started Jan 2019

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

First Submitted

Initial submission to the registry

December 4, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

January 3, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2021

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

2.5 years

First QC Date

December 4, 2018

Last Update Submit

April 3, 2025

Conditions

Prostate Cancer

Keywords

Prostate CancerPET/CTPSMAC-11 Choline

Outcome Measures

Primary Outcomes (1)

  • Tumor Detection on PET/CT

    Positive predictive value on a per-patient and per-region-basis of PSMA and C-11 choline PET/CT for detection of tumor location confirmed by histopathology/biopsy or conventional imaging follow-up.

    12 Months post PET/CT

Secondary Outcomes (2)

  • Impact of PSMA and C-11 choline PET on clinical management

    12 Months

  • Incidence of adverse events attributable to PSMA

    12 Months

Study Arms (2)

PET/CT Ga-68 PSMA

EXPERIMENTAL

Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT

Drug: Ga-68 PSMA11

PET/CT F-18 Labeled PSMA 1007

EXPERIMENTAL

F-18 Labeled PSMA 1007 PET/CT

Drug: F-18 PSMA 1007

Interventions

Ga-68 PSMA11DRUG

Ga-68 PSMA11 PET/CT for detection of tumor location

PET/CT Ga-68 PSMA
F-18 PSMA 1007DRUG

F-18 PSMA 1007 PET/CT for detection of tumor location

PET/CT F-18 Labeled PSMA 1007

Eligibility Criteria

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

You may qualify if:

  • Histopathological proven prostate adenocarcinoma.
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
  • a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. \> 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
  • Karnofsky performance status of 50 (or ECOG/WHO equivalent).
  • CT or as part of the PET study or performed within one month of PSMA PET.
  • Age \> 18.
  • Ability to understand a written informed consent document, and the willingness to sign it.

You may not qualify if:

  • Undergoing investigational therapy for prostate cancer.
  • Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects).
  • Unable to lie flat, still or tolerate a PET scan.
  • Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
  • Absence of PSA and total testosterone tests within 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

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

Study Officials

  • Val Lowe, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 7, 2018

Study Start

January 3, 2019

Primary Completion

July 21, 2021

Study Completion

July 21, 2021

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

The IPD data from this trial will be available to other researchers that will collate similar data from multiple sites to provide data to the FDA.

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
After completion of the trial and IPD will be available for 2 years.
Access Criteria
Researchers collating data from multiple sites for submission to the FDA will be provided access to the IPD.

Locations

US(1)