18F-FACBC PET/CT FOR STAGING HIGH RISK PROSTATE CANCER

Phase 1

• Conditions: Patients affected by moderate to high risk primary prostate cancer who are scheduled for surgery with a planned, elective lymph node dissection; MedDRA version: 17.0Level: LLTClassification code 10036946Term: Prostatic cancerSystem Organ Class: 100000004864; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2014-003165-15-IT
• Lead Sponsor: AOU di Bologna Policlinico S.Orsola-Malpighi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-27
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 110

Inclusion Criteria

1.Subjects with biopsy-proven adenocarcinoma of the prostate
2.Moderate- to high risk prostate cancer as defined by:
-Moderate risk: T2b-T2c or Gleason score 7 or PSA 10-20 ng/mL;
-High risk: T3a or Gleason score 8-10 or PSA > 20 ng/mL.
3. Staging according to conventional preoperative workup tests (digital rectal examination, transrectal ultrasound, biopsy, likelihood of lymph node metastasis with clinical nomograms, Choline PET/CT)
4. Choline PET/CT negative for bone metastases
5.Surgical plan: prostatectomy with limited or extended lymph node dissection within 40 days from the imaging
6.Age=18

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 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

1.Inability to undergo 18F-FACBC PET/CT scanning for any reason.
2.Prior invasive malignancy (except basal cell carcinoma) unless disease-free for a minimum of 3 years
3.Severe acute co-morbidity
4.Specific preoperative therapy (hormonal treatment, chemotherapy, radiotherapy

Study & Design

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