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

The Swedish National Prostate Cancer Register (Sweden)0 个研究点目标入组 500 人开始时间: 2011年2月17日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

The Swedish National Prostate Cancer Register (Sweden)