NCT02282137

Brief Summary

This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix™) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer, as well as prostate cancer that may have come back in patients with elevated PSA ( a prostate-specific antigen tumor marker) after initial treatment.

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
208

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started May 2015

Longer than P75 for phase_2 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

First Submitted

Initial submission to the registry

October 27, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 4, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

7.6 years

First QC Date

October 27, 2014

Last Update Submit

August 17, 2020

Conditions

Prostate Cancer

Keywords

Prostate cancerPET / CTGa-PSMA

Outcome Measures

Primary Outcomes (1)

  • The sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.

    The sensitivity of 68Ga-PSMA-11 PET to detect tumor location and metastases in patients with biopsy confirmed diagnosis.tumor location confirmed by histopathology/biopsy and conventional imaging follow-up.

    12 months

Secondary Outcomes (1)

  • Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value

    12 months

Study Arms (1)

68Ga-PSMA

EXPERIMENTAL

Evaluation of concordance and discordance between the results of 68Ga-PSMA PET/CT and other available conventional imaging modalities (such as CT, MRI, FDG, NaF scan), histology or follow up.

Drug: 68Ga-PSMA

Interventions

68Ga-PSMADRUG

Patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.

Also known as: 68Ga-HBED-CC-PSMA
68Ga-PSMA

Eligibility Criteria

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

You may qualify if:

  • General requirements:
  • Karnofsky performance status of ≥50 (or ECOG/WHO equivalent).
  • Age \> 18 years .
  • Ability to understand a written informed consent document, and the willingness to sign it.
  • Biopsy proven prostate adenocarcinoma.
  • Planned prostatectomy with lymph node dissection.
  • Intermediate to high-risk disease (as determined by elevated PSA \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors).
  • Histopathological proven prostate adenocarcinoma.
  • Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
  • Post radical prostatectomy (RP) - AUA recommendation, PSA greater than or equal to 0.2 ng/mL measured more than 6 weeks after RP.
  • Post-radiation therapy -ASTRO-Phoenix consensus definition, Nadir + greater than or equal to 2 ng/mL rise in PSA 5. Diagnostic CT or MRI as part of the PET study or performed within one month of PSMA PET

You may not qualify if:

  • General requirements:
  • Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
  • Investigational therapy for prostate cancer for less than 2 months.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radio- Isotope Therapy of America

Houston, Texas, 77042, United States

RECRUITING

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

  • Rodolfo Nunez, MD

    Excel Diagnostics and Nuclear Oncology Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Cork

CONTACT

713-781-6200Scork@exceldiagnostics.com

Rodolfo Nunez, MD

CONTACT

713-781-6200Rnunez@exceldiagnostics.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman and Medical Director

Study Record Dates

First Submitted

October 27, 2014

First Posted

November 4, 2014

Study Start

May 1, 2015

Primary Completion

December 1, 2022

Study Completion

December 1, 2023

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations

US(1)