Cancer Diagnosis by Multiparametric UltraSound of the Prostate (CADMUS)

University College London (UCL)

Status: Unknown

Conditions: Prostate Cancer

Treatments: Procedure: multiparametric MRI. Multi-parametric ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT02712684

15/0473

Details and patient eligibility

About

In men who require a prostate biopsy does a multi-parametric ultrasound based diagnostic strategy compared to a multi-parametric MRI based diagnostic strategy lead to similar detection of clinically significant prostate cancer?

Full description

Men who require prostate biopsy will be approached and consented to enter this study. Participants will all undergo pre-biopsy mp-MRI and mp-USS of the prostate. Only men with positive scans will undergo prostate biopsy. The order in which lesions discovered on mp-MRI or on mp-USS are sampled will be randomised. All biopsies will be taken via the transperineal route in a single procedure. Comparison will be drawn between biopsy results of lesions detected by mp-USS with those lesions detected by mp-MRI. Consideration will be given as to whether a lesion detected by one imaging modality is the same abnormality as one detected by the other imaging modality, in the same patient. Analysis will be carried out at both the level of the lesion and the whole prostate. Men without suspicious lesions on either imaging modality will not proceed to biopsy.

Enrollment: 500 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A potential need for prostate biopsy indicated by raised PSA or other clinical parameter, the final decision over which will be taken after imaging.
2. PSA </=20ng/ml measured within 6 months of screening visit
3. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process
4. Estimated life expectancy of 5 years or more
5. Signed informed consent

Exclusion criteria

1. Any contraindication to the ultrasound contrast agent including right to left shunt, pulmonary hypertension, uncontrolled hypertension and adult respiratory distress syndrome. Also patients with a recent acute coronary syndrome or unstable ischaemic heart disease.
2. Any form of hormones (except 5-alpha reductase inhibitors) within 6 months of screening visit
3. Irreversible coagulopathy predisposing to bleeding
4. Inability to undergo transrectal ultrasonography
5. Prostate volume, measured at the time of mp-USS if previously unknown, of >60cc.
6. Previous radiation therapy to the prostate
7. Previous HIFU, cryosurgery, thermal therapy, irreversible electroporation, photodynamic, photothermal therapy, microwave or injectable toxin therapy to the prostate.
8. Transurethral resection or vaporization of the prostate for benign prostatic hyperplasia using any energy modality within 6 months of screening visit
9. Nodal or metastatic prostate cancer on any form of imaging at any time-point
10. Not fit for general anaesthetic
11. Any other condition the investigator considers would make the patient unsuitable