NCT03609528

Brief Summary

The CamPROBE study investigates the rate of infective complications using the Cambridge Prostate Biopsy Device method of local anaesthetic transperineal prostate biopsies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

June 6, 2018

Last Update Submit

December 6, 2019

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Incidence of Infection

    Changes in incidence of infection as measured using patient self-reported Follow-Up Questionnaires and telephone assessments.

    30 days post biopsy

Secondary Outcomes (3)

  • Patient reported pain score

    30 days post biopsy

  • Biological functions post biopsy

    30 days post biopsy

  • Patient willingness to have a repeat biopsy

    30 days post biopsy

Other Outcomes (1)

  • Clinician Perception

    1 day

Study Arms (1)

CamPROBE biopsy method

EXPERIMENTAL

To be completed

Device: CamPROBE

Interventions

CamPROBEDEVICE

To be completed

CamPROBE biopsy method

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • To be included in the clinical investigation the participant must:
  • Have given written informed consent to participate
  • Be aged 18 years and over
  • Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic or surveillance purposes
  • Be willing and able to comply with scheduled visits and completion of study questionnaires

You may not qualify if:

  • Contraindication to a prostate biopsy
  • Previous perineal or anal surgery
  • Unable to lie down with legs in a stirrup for at least 45 minutes, as assessed by a clinician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr

Study Record Dates

First Submitted

June 6, 2018

First Posted

August 1, 2018

Study Start

February 15, 2019

Primary Completion

October 2, 2019

Study Completion

October 2, 2019

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations

GB(1)