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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04483414
Other study ID # STU-2020-0488
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date March 19, 2021
Est. completion date April 5, 2023

Study information

Verified date May 2023
Source University of Texas Southwestern Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

In developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. Following primary therapy for prostate cancer, a substantial number of patients will recur either locally in the pelvis or in extra pelvic locations. Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA) after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence. This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer compared to conventional imaging. In addition, we will evaluate its performance in assessing interim and post salvage therapy response compared to conventional imaging, including pelvic magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 5, 2023
Est. primary completion date April 5, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
68Ga PSMA-11 injection
Injection of 68Ga PSMA-11
Procedure:
Positron Emission Tomography/Computed Tomography
PET/CT scan after 68Ga PSMA-11 injection

Locations

Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Dana Mathews

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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