A study of Positron/Computerized Tomography (PET/CT) with 18F-PSMA1007 versus 18F-Choline to compare the detection rate of prostate cancer relapse after definite treatment

Phase 1

• Conditions: Prostate cancer recurrent; MedDRA version: 21.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-001302-15-GR
• Lead Sponsor: BIOKOSMOS S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

1. Male with original diagnosis of prostate carcinoma with prior definitive therapy
2. Suspicion of recurrence (3 consecutive PSA rises and/or PSA rise by 2.0 ng/mL or more above
nadir after radiotherapy or cryotherapy and/or PSA rise by greater than 0.2 ng/mL after
prostatectomy)
3. Life expectancy of 6 months or more as judged by the investigator
4. Willing and able to undergo all study procedures
5. Informed consent in writing (dated and signed)
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 114
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

1. Age: less than18 years
2. Contraindications for F-18-Fluorocholine
3. Contraindications for any of the ingredients of F-18-PSMA-1007
4. Close affiliation with the investigational site; e.g. first-degree relative of the investigator
5. Participating in another therapeutic clinical trial or has completed study participation in
another therapeutic clinical trial within 5 days of enrolment into this trial
6. Having been previously enrolled in this clinical trial
7. Mental conditions rendering the subject incapable to understand the nature, scope, and
consequences of the trial
8. Being clinically unstable or requiring emergency treatment

Study & Design

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