Skip to content

The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer

The ProtecT trial - Evaluating the effectiveness of treatment for clinically localised prostate cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20141297
Enrollment
116500
Registered
2002-10-14
Start date
2001-10-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer Cancer Malignant neoplasm of prostate

Interventions

Current interventions as of 14/08/2013: 1. Radical prostatectomy 2. Radical radiotherapy 3. Active monitoring: monitoring of the disease including prostate specific antigen levels Previous interventi

Sponsors

University of Oxford (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Men aged 50-69 years from the community, localised prostate cancer for eligibility for randomisation

Exclusion criteria

Exclusion criteria: Not provided at time of registration.

Design outcomes

Primary

MeasureTime frame
Current primary outcome measures as of 18/03/2019: 1. Disease-specific survival at 15 years. 2. Disease progression (biochemical and clinical). 3. Treatment complications (long term). 4. Lower urinary tract symptoms. 5. Psychosocial impact of treatment including generic health status, quality of life and sexual function. 6. Prostate cancer specific survival. 7. Overall survival. Previous primary outcome measures as of 14/08/2013: 1. Disease-specific survival at 10 years Previous primary outcome measures as of 27/09/2010: 1. Disease progression (biochemical and clinical) 2. Treatment complications 3. Lower urinary tract symptoms 4. Psychosocial impact of case-finding and treatment including generic health status, quality of life and sexual function 5. Prostate cancer specific survival 6. Overall survival Previous primary outcome measures as of 14/10/2002: 1. Disease progression (biochemical and clinical) 2. Treatment complications 3. Lower urinary tract symptoms 4. Psychosocial impact of case-finding and treatment including generic health status, quality of life and sexual function

Secondary

MeasureTime frame
Current secondary outcome measures as of 21/07/2021: 1. Overall survival 2. Disease progression (biochemical and clinical) 3. Lower urinary tract symptoms 4. Psychosocial impact of cancer diagnosis and treatment including generic health status, quality of life and sexual function 5. Cost-effectiveness of the treatments 15 year median analysis no health economic analysis Previous secondary outcome measures added 14/08/2013: 1. Overall survival 2. Disease progression (biochemical and clinical) 3. Lower urinary tract symptoms 4. Psychosocial impact of cancer diagnosis and treatment including generic health status, quality of life and sexual function 5. Cost-effectiveness of the treatments

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 8, 2026