PSMA and C-11 Choline PET in Patients With Biochemical Recurrence of Prostate Cancer
NCT ID: NCT03768349
Last Updated: 2025-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
250 participants
INTERVENTIONAL
2019-01-03
2021-07-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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PET/CT Ga-68 PSMA
Ga-68 labeled PSMA-11 (or PSMA-HBED-CC) PET/CT
Ga-68 PSMA11
Ga-68 PSMA11 PET/CT for detection of tumor location
PET/CT F-18 Labeled PSMA 1007
F-18 Labeled PSMA 1007 PET/CT
F-18 PSMA 1007
F-18 PSMA 1007 PET/CT for detection of tumor location
Interventions
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Ga-68 PSMA11
Ga-68 PSMA11 PET/CT for detection of tumor location
F-18 PSMA 1007
F-18 PSMA 1007 PET/CT for detection of tumor location
Eligibility Criteria
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Inclusion Criteria
2. Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).
a. Post radical prostatectomy (RP) - with or without radiation. i. PSA greater than or equal to 0.2 ng/mL measured more than 12 weeks after RP. ii. \> 3 months post-surgery b. Post-radiation therapy ASTRO-Phoenix consensus definition c. May or may not be castrate resistant (list prior therapies)
3. Karnofsky performance status of 50 (or ECOG/WHO equivalent).
4. CT or as part of the PET study or performed within one month of PSMA PET.
5. Age \> 18.
6. Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria
2. Other ongoing treatments for prostate cancer including radiation therapy, chemotherapy or androgen deprivation. Androgen deprivation within the last 4 months excluding finasteride, dutasteride or other 5 alpha reductase inhibitors (excluding castrate resistant subjects).
3. Unable to lie flat, still or tolerate a PET scan.
4. 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.
6. Absence of PSA and total testosterone tests within 4 weeks.
18 Years
MALE
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Val Lowe
Prinicpal Investigator
Principal Investigators
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Val Lowe, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2019-07001
Identifier Type: REGISTRY
Identifier Source: secondary_id
18-006159
Identifier Type: OTHER
Identifier Source: secondary_id
MC1952
Identifier Type: OTHER
Identifier Source: secondary_id
18-006159
Identifier Type: -
Identifier Source: org_study_id
NCT04144010
Identifier Type: -
Identifier Source: nct_alias
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