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

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ClinicalTrials.gov Identifier: NCT04483414
Recruitment Status : Recruiting
First Posted : July 23, 2020
Last Update Posted : February 7, 2022
Sponsor:
Information provided by (Responsible Party):
Dana Mathews, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Cancer Metastatic Prostate Cancer Metastatic to Bone Drug: 68Ga PSMA-11 injection Procedure: Positron Emission Tomography/Computed Tomography Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Unblinded, single arm imaging study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy
Actual Study Start Date : March 19, 2021
Estimated Primary Completion Date : September 19, 2023
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Gallium

Arm Intervention/treatment
Experimental: Patients with suspected BCR or metastatic prostate cancer
Patients with suspected BCR or metastatic prostate cancer
Drug: 68Ga PSMA-11 injection
Injection of 68Ga PSMA-11

Procedure: Positron Emission Tomography/Computed Tomography
PET/CT scan after 68Ga PSMA-11 injection
Other Name: PET/CT




Primary Outcome Measures :
  1. Location of recurrence [ Time Frame: Up to 3 years ]
    Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.

  2. Residual prostate cancer [ Time Frame: Up to 3 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483414


Contacts
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Contact: Kelli Key, PhD 214-648-8152 Kelli.Key@UTSouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Kelli Key, PhD    214-648-8152    Kelli.Key@UTSouthwestern.edu   
Principal Investigator: Neil Rofsky, MD, MHA         
Sponsors and Collaborators
Dana Mathews
Investigators
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Principal Investigator: Neil Rofsky, MD, MHA UT Southwestern Medical Center
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Responsible Party: Dana Mathews, Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT04483414    
Other Study ID Numbers: STU-2020-0488
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: February 7, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dana Mathews, University of Texas Southwestern Medical Center:
PET/CT
prostate cancer
Gallium-68
PSMA-11
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Gallium 68 PSMA-11
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action