The ProCare Trial: A randomised controlled trial of follow up of men with prostate cancer in primary care.

Phase 2

Recruiting

• Conditions: Prostate cancer; Cancer - Prostate

• Registration Number: ACTRN12610000938000
• Lead Sponsor: Primary Care Collaborative Cancer Clinical Trials Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-11-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 188

Inclusion Criteria

1. Pathologically confirmed diagnosis of prostate cancer.
2. Completed surgery and / or radiotherapy with curative intention within 3 weeks of study entry
3. Able to read and write English at a level sufficient to give informed consent and complete study procedures including written questionnaires without an interpreter.
4. Have a general practitioner who agrees to participate in the Trial.

Exclusion Criteria

1. Suspicion or evidence of metatastic disease
2. Severe psychiatric or cognitive disorder, which in the opinion of the investigator would compromise participation in the study.
3. Treatment with palliative intent.
4. No general practitioner.
5. Patients with a pathologically confirmed diagnosis of prostate cancer with any of the following high risk features (cT3; PSA greater than 20; or Gleason score greater than or equal to 8)
6. Patients having androgen deprivation therapy following radiotherapy, irrespective or risk level

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: Trial feasibility as measured by patient recruitment and attrition rates, GP recruitment rates, and response rates to outcome measures[At two years after commencement of the Trial.];Primary Outcome 2: Assessment of psychological distress as measured using the Hospital Anxiety and Depression Scale (HADS) mean scores.[At baseline, and then at 3 months, 6 months and 12 months];Primary Outcome 3: Assessment of health-related quality of life as measured using mean scores for: <br><br>The Cancer Survivors' Unmet Needs measure (CaSUN) <br>The Expanded Prostate Cancer Index Composite (EPIC) <br>The Short-form Patient Satisfaction Questionnaire (PSQ-18)[At baseline, and then at 3 months, 6 months and 12 months]

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome 1: Prostate cancer recurrence rates and detection, as assessed by use of PSA according to protocol based on Medical Benefits Schedule (MBS) pathology data.[From date of randomisation to 2 months after the 12-month follow-up visit.];Secondary Outcome 2: Incidence of depression, as assessed by PSA data for antidepressants and MBS data on clinical data on clinical psychologists' referrals.[From date of randomisation to 2 months after the 12-month follow-up visit.]