68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer

NCT04483414 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: STU-2020-0488
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to detect sites of recurrent prostate cancer in patients with biochemical recurrence previously treated with radical prostatectomy (RP) or external beam radiation (EBRT) and to assess treatment response to subsequent salvage therapy.

Conditions

Prostate Cancer; Prostate Cancer Metastatic; Prostate Cancer Metastatic to Bone

Keywords

PET/CT; prostate cancer; Gallium-68; PSMA-11

Outcome Measures

Primary Outcomes (2)

• Location of recurrence

  Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.

  Up to 3 years

• Residual prostate cancer

  For imaging during or after salvage therapy, existence of residual prostate cancer will be determined for each patient on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.

  Up to 3 years

Study Arms (1)

Patients with suspected BCR or metastatic prostate cancer

EXPERIMENTAL

Patients with suspected BCR or metastatic prostate cancer

Drug: 68Ga PSMA-11 injection; Procedure: Positron Emission Tomography/Computed Tomography

Interventions

68Ga PSMA-11 injection DRUG

Injection of 68Ga PSMA-11

Patients with suspected BCR or metastatic prostate cancer

Positron Emission Tomography/Computed Tomography PROCEDURE

PET/CT scan after 68Ga PSMA-11 injection

Also known as: PET/CT

Patients with suspected BCR or metastatic prostate cancer

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected BCR of prostate cancer following initial treatment with either prostatectomy or definitive EBRT of the prostate or patients with known metastatic prostate cancer who have failed systemic therapy.
• Patients being considered for salvage therapy.
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
• Patients must be medically stable as judged by the patient's physician.
• Patients must be able to lie still for 20-40 minutes for the PET/CT scans.
• Ability to understand and the willingness to sign a written informed consent.
• Patients with BCR and no known lesions should not be on antiandrogen therapy at the time of scans. Patients with known metastases who are currently being treated with anti-androgen therapy may remain on this medication.

You may not qualify if:

• Patients who have or have had a biopsy proven concurrent other malignancy, excluding skin cancers.
• Patients may not weigh more than the maximum weight limit for the PET /CT scanner table (\> 200 kg or 440 pounds).
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11. Furosemide will not be administered to patients with known allergy.
• Patients must not be claustrophobic.

Sponsors & Collaborators

• Dana Mathews: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

gallium 68 PSMA-11; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Orhan K Oz, MD, PhD

  University of Texas Southwestern Medical Center

  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: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Unblinded, single arm imaging study

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: March 19, 2021
• Primary Completion: April 5, 2023
• Study Completion: April 5, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)