Phase III study for evaluation of the diagnostic performance of [18F]CTT1057 PET imaging in patients with prostate cancer with rising PSA levels [biochemical recurrence (BCR)] (GuidePath) - GuidePath

ovartis Farmacéutica S.A.0 sites190 target enrollmentAugust 20, 2021

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prostate cancer with rising PSA levels [biochemical recurrence (BCR)]
Sponsor: ovartis Farmacéutica S.A.
Enrollment: 190
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

August 20, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

ovartis Farmacéutica S.A.

•1\. Signed informed consent must be obtained prior to participation in the study
•2\. Biopsy proven prostate adenocarcinoma.
•3\. Biochemical recurrence defined by American Urological Association (AUA) criteria for patients who have undergone radical prostatectomy (detectable or rising PSA value measured 6–13 wk after surgery, that is \=0\.2 ng/mL with a second determination of a PSA level\>0\.2 ng/mL at least 2 week apart) and by American Society for Radiation Oncology (ASTRO)\-Phoenix criteria for patients who have undergone curative\-intent radiotherapy (PSA\=2 ng/mL above the nadir).
•4\. Eastern Cooperative Oncology Group (ECOG) performance status 0\-2
•5\. Participants must be adults \= 18 years of age
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 57
•F.1\.3 Elderly (\>\=65 years) yes

•1\. Inability to complete the needed investigational and standard\-of\-care imaging examinations due to any reasons (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
•2\. Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and Coronavirus Disease 2019 (COVID\-19\)
•3\. Prior major surgery undergone less than 12 weeks prior to screening (with the exception of any surgery related to prostatic cancer)
•4\. Known allergy, hypersensitivity, or intolerance to \[18F]CTT1057, \[68Ga]Ga\-PSMA\-11, or to CT contrast
•5\. Prior and current use of PSMA targeted therapies
•6\. Prior and current treatment with Luteinizing Hormone\-Releasing Hormone (LHRH) analogues
•7\. Any prior ADT (first or second generation) within 9 months before screening
•8\. Any 5\-alpha reductase inhibitors within 30 days before screening
•9\. Use of other investigational drugs within 30 days before screening
•10\. Castration\-resistant patients