68Ga-PSMA HBED-PET/CT in the Evaluation of the Biochemical Relapse in Patients With a History of Prostate Cancer Radically Treated
NCT ID: NCT02920229
Last Updated: 2025-01-09
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
NA
1230 participants
INTERVENTIONAL
2015-11-30
2020-10-09
Brief Summary
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Detailed Description
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The secondary objectives are:
* Sensitivity for different Prostatic Specific Antigen (PSA) values (ranges)
* Sensitivity for different lesion sites
* Treatment response assessment with a second PET
* False positives detection during Follow Up (FUP) (with other standard methods and eventually optional biopsy) for patient without any treatment
* safety 67 evaluable patients will be injected with 100-200 megabecquerel (MBq) 68Ga-PSMA intravenously
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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68Ga- PSMA PET/CT
100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT
68Ga- PSMA
100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT
Interventions
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68Ga- PSMA
100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT
Eligibility Criteria
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Inclusion Criteria
2. Male, aged \>18 years.
3. Radical treatment for prostate cancer (radiotherapy or surgery)
4. 18F-FMC PET/CT negative or doubtful
5. Negativity of all the other traditional morphological and functional imaging (transrectal ultrasound, bone scan, CT/MRI)
6. Patients with PSA progression defined as PSA ≥ 1,0 ng/mL and/or PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
7. Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
8. Participant is willing and able to give informed consent for participation in the study.
Exclusion Criteria
2. No radiotherapy in the last 6 months.
3. Patients with PSA \< 1.0 ng/ml
4. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
6. Medical or psychological conditions that would not permit the subject to complete to sign informed consent
19 Years
MALE
No
Sponsors
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
OTHER
Responsible Party
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Principal Investigators
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Federica Matteucci, MD
Role: PRINCIPAL_INVESTIGATOR
IRST IRCCS, Meldola (FC)
Locations
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Irst Irccs
Meldola, FC, Italy
Countries
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Other Identifiers
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2015-003397-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IRST185.02
Identifier Type: -
Identifier Source: org_study_id
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