NCT01304485

Brief Summary

Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_2 prostate-cancer

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

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

7.8 years

First QC Date

February 24, 2011

Last Update Submit

March 5, 2019

Conditions

Prostate Cancer

Keywords

Recurrent Prostate Carcinomasodium acetate c11PETprostate cancerrising PSAPSA recurrencebiochemical recurrence

Outcome Measures

Primary Outcomes (1)

  • SUV (Standardized Uptake Value)

    Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.

    Day1 - Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration

Secondary Outcomes (1)

  • PSA (prostate specific antigen)

    Every 3 - 6 months for 24 months after PET imaging

Study Arms (1)

Sodium Acetate C11 PET Imaging

EXPERIMENTAL
Drug: Sodium Acetate C11

Interventions

Sodium Acetate C11DRUG

PET Imaging with Sodium Acetate C11

Also known as: Carbon 11 Acetate PET, C11 Acetate, AC-PET
Sodium Acetate C11 PET Imaging

Eligibility Criteria

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

You may qualify if:

  • recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)

You may not qualify if:

  • \< 18 years old
  • claustrophobic patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phoenix Molecular Imaging

Phoenix, Arizona, 85040, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

carbon-11 acetate

Condition Hierarchy (Ancestors)

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

Study Officials

  • Fabio Almeida, M.D.

    Medical Director, Phoenix Molecular Imaging

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fabio Almeida MD, Medical Director

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 7, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

Journal Publication

Locations

US(1)