Diagnostic performance of [18F]CTT1057 PET versus pathology

Phase 1

• Conditions: ntreated high risk prostate cancer; MedDRA version: 21.0Level: PTClassification code 10036918Term: Prostate cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-003958-67-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-20
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 195

Inclusion Criteria

1. Untreated high risk biopsy-proven PCa patients according to D’Amico classification (Stage T2c or PSA level >20ng/ml or Gleason score =8)
2. Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
3. ECOG performance status 0-2
4. Signed informed consent must be obtained prior to participation in the study
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 58
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 137

Exclusion Criteria

1. Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (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 COVID-19.
3. Known allergy, hypersensitivity, or intolerance to [18F]CTT1057
4. Prior and current use of PSMA targeted therapies
5. Prior and current treatment with LHRH analogues
6. Any prior ADT (first or second generation) within 9 months before screening
7. Any 5-alpha reductase inhibitors within 30 days before screening
8. Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
9. Patients with incidental PCa after transuretheral resection
10. Use of other investigational drugs within 30 days before screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified