Magnetic resonance imaging-targeted biopsy compared to standard trans-rectal ultrasound guided biopsy for the diagnosis of prostate cancer in men without prior biopsy

Not Applicable

Completed

• Conditions: Topic: Cancer, Renal disorders; Subtopic: Prostate Cancer, Renal disorders; Disease: Prostate, All Renal disorders; Cancer

• Registration Number: ISRCTN18440098
• Lead Sponsor: CL Clinical Trials Unit

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29025845 (added 09/08/2019) 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/29552975 (added 09/08/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-29
• Study Completion: 2017-12-01
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 500

Inclusion Criteria

1. Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
2. Serum PSA = 20ng/ml
3. Suspected stage = T2 on rectal examination (organ-confined prostate cancer)
4. Fit to undergo all procedures listed in protocol
5. Able to provide written informed consent

Exclusion Criteria

1. Prior prostate biopsy
2. Prior treatment for prostate cancer
3. Contraindication to MRI
4. Contraindication to prostate biopsy
5. Men in whom artifact would reduce the quality of the MRI
6. Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
7. Unfit to undergo any procedures listed in protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified