Optimisation of [68Ga] PSMA-11 PET/CT Imaging Protocol for finding the location of prostate cancer lesions in patients who were newly diagnosed with prostate cancer

Phase 1

• Conditions: Primary localised prostate cancer, in men who opt for active treatment in the form of a radical prostatectomy; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2016-002485-31-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-26
• Last Update Posted: 13 February 2017

Recruitment & Eligibility

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

Inclusion Criteria

•Male aged 18 years or older
•Ability to provide signed informed consent and willingness to comply with protocol requirements.
•Biopsy confirmed presence of adenocarcinoma of the prostate gland
•Planned/already executed mpMRI (standard of care).
•Planned for radical prostatectomy (standard of care).
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
;
•Male aged 18 years or older
•Ability to provide signed informed consent and willingness to comply with protocol requirements.
•Biopsy confirmed presence of adenocarcinoma of the prostate gland
•Planned/already executed mpMRI (standard of care).
•Planned for radical prostatectomy (standard of care).
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
;
•Male aged 18 years or older
•Ability to provide signed informed consent and willingness to comply with protocol requirements.
•Biopsy confirmed presence of adenocarcinoma of the prostate gland
•Planned/already executed mpMRI (standard of care).
•Planned for radical prostatectomy (standard of care).
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 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

•Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B)
•Have a contraindication for mpMRI. (part A and B)
•Will not undergo a radical prostatectomy. (part A and B)
•Claustrophobia (part A and B)
•Multiple malignancies (part A and B)
•Anticoagulant therapy (part A)
•Obese (>120 kg) (part A)
•Have undergone a transurethral resection of prostate in the past (part A and B)
;
•Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B)
•Have a contraindication for mpMRI. (part A and B)
•Will not undergo a radical prostatectomy. (part A and B)
•Claustrophobia (part A and B)
•Multiple malignancies (part A and B)
•Anticoagulant therapy (part A)
•Obese (>120 kg) (part A)
•Have undergone a transurethral resection of prostate in the past (part A and B)
;
•Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives, or completing the study. (part A and B)
•Have a contraindication for mpMRI. (part A and B)
•Will not undergo a radical prostatectomy. (part A and B)
•Claustrophobia (part A and B)
•Multiple malignancies (part A and B)
•Anticoagulant therapy (part A)
•Obese (>120 kg) (part A)
•Have undergone a transurethral resection of prostate in the past (part A and B)

Study & Design

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