A Swedish trial comparing two different follow-up schedules for patients with low-risk prostate cancer on active surveillance with selective, delayed treatment

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN64891728
• Date of registration: 17/02/2011
• Prospective Registration: No
• Primary sponsor: The Swedish National Prostate Cancer Register (Sweden)
• Public title: A Swedish trial comparing two different follow-up schedules for patients with low-risk prostate cancer on active surveillance with selective, delayed treatment
• Scientific title: A Swedish randomised, multicentre, controlled trial comparing two different follow-up schedules for patients with low-risk, localised prostate cancer on active surveillance with selective, delayed intervention with curative intent
• Date of first enrolment: 15/02/2011
• Target sample size: 500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN64891728
• Study type: Interventional
• Study design: Prospective multicentre randomised controlled study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Ola Bratt

Key inclusion & exclusion criteria

Inclusion criteria: 1. Males aged 50 to 75 years
2. Expected remaining life-time of more than 10 years
3. Diagnosis of prostate cancer within the previous 6 months
4. Local therapy with curative intent is planned to be given if progression during follow-up
5. The patient has understood the concept of active surveillance and signed informed consent
6. Prostate specific antigen (PSA) less than 10 µg/l
7. PSA density less than 0.2 µg/l/cc
8. PSA free to total ratio greater than or equal to 0.1 (10%)
9. PSA-DT (doubling time) greater than 3 years during the last 2 years (if PSA-history available)
10. PSA increase of less than 2 µg/l within the last 2 years (if PSA-history available)
11. Tumour stage T1c or T2a (UICC 2002)
12. Prostate volume less than 90 cc
13. Gleason score less than or equal to 6 with no grade 4 or 5
14. Peripheral zone prostate cancer diagnosed with a set of biopsies including 6 - 12 cores
15. Less than or equal to 25% of cores with cancer
16. Less than or equal to 4 mm cancer in any one biopsy
Exclusion criteria: 1. Cancer in prostate biopsy cores sampling exclusively the anterior parts of the gland
2. Cancer diagnosed at TUR-P
3. Evidence of metastatic cancer
4. Any previous therapy for prostate cancer
5. Treatment with 5-alpha-reductase inhibitors during the previous 12 months
6. Additional sets of prostate biopsies within the previous 12 months
7. Recurrent urinary tract infection or bacterial prostatitis
8. Ano-rectal disease interfering with digital rectal examination or ultrasound
9. Any other disease or circumstance that may interfere will study-related procedures

Age minimum:
Age maximum:
Gender: Male

Health Condition(s) or Problem(s) studied

Localised prostate cancer
Cancer
Prostate cancer

Intervention(s)

Randomisation (1:1) within 6 months from diagnosis of prostate cancer, either to a standard set of prostate biopsies (9-16 cores depending on prostate volume) with standard follow-up (see below), or a more extensive set of biopsies (experimental arm, 15-26 cores depending on prostate volume) with less intensive follow-up.

Standard follow-up: PSA every 3 months for 2 years, then every 6 months; digital rectal examination every 6 months for 2 years, then annually; repeat standard biopsies every 24 months.

Follow-up in the experimental arm: PSA every 6 months for 2 years, than annually; digital rectal examination annually; no repeat biopsies unless any criterion for therapy is fulfilled, but no therapy initiated.

Patients will be followed prospectively for 5 years for the primary end-point and up to 15 years for the secondary end-points.

Primary Outcome(s)

1. Active therapy for prostate cancer with curative intent within 5 years from diagnosis.
2. The first analysis for the primary end-point will be performed 1 year after inclusion of the last patient.
3. The second and final analysis will be performed 5 years after inclusion of the last patient.

Secondary Outcome(s)

1. The first analysis for secondary end-points will be performed after inclusion of the last patient. Subsequent analyses will be performed 5 and 10 years after inclusion of the last patient.
2. Detection of more extensive or less differentiated cancer in repeat biopsy
3. Therapy for prostate cancer with curative intent after more than 5 years from diagnosis
4. Recurrence following therapy with curative intent
5. Tumour characteristics in specimens from radical prostatectomy
6. Therapy for prostate cancer with non-curative intent
7. Change of strategy to expectancy without curative intent
8. Symptoms of prostate cancer and side-effects of treatment
9. Quality of life
10. Development of distant metastases
11. Death from prostate cancer
12. Death from other causes

Secondary ID(s)

2.0

Source(s) of Monetary Support

Stig and Ragna Gorthon?s Research Foundation (Sweden), Örebro läns landstings särfond nr 5 (Sweden), Gunnar Nilsson?s Research Foundation (Sweden), Swedish Cancer Foundation (Sweden)