Back to results68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer
Primary Purpose
Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Metastatic to Bone
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68Ga PSMA-11 injection
Positron Emission Tomography/Computed Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring PET/CT, prostate cancer, Gallium-68, PSMA-11
Eligibility 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.
Sites / Locations
- UT Southwestern Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with suspected BCR or metastatic prostate cancer
Arm Description
Patients with suspected BCR or metastatic prostate cancer
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04483414
Brief Title
68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study was closed since no participants were enrolled.
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
April 5, 2023 (Actual)
Study Completion Date
April 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dana Mathews
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer Metastatic to Bone
Keywords
PET/CT, prostate cancer, Gallium-68, PSMA-11
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Unblinded, single arm imaging study
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with suspected BCR or metastatic prostate cancer
Arm Type
Experimental
Arm Description
Patients with suspected BCR or metastatic prostate cancer
Intervention Type
Drug
Intervention Name(s)
68Ga PSMA-11 injection
Intervention Description
Injection of 68Ga PSMA-11
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography/Computed Tomography
Other Intervention Name(s)
PET/CT
Intervention Description
PET/CT scan after 68Ga PSMA-11 injection
Primary Outcome Measure Information:
Title
Location of recurrence
Description
Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
Time Frame
Up to 3 years
Title
Residual prostate cancer
Description
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.
Time Frame
Up to 3 years
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orhan K Oz, MD, PhD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
68Ga PSMA-11 PET/CT in Recurrent Prostate Cancer
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