IntroductionOvertreatment of localised prostate cancer is substantial despite increased use of active surveillance. No randomised trials help define how to monitor patients or when to initiate treatment with curative intent.Methods and analysisA randomised, multicentre, intervention trial designed to evaluate the safety of an MRI-based active surveillance protocol, with standardised triggers for repeated biopsies and radical treatment. The aim is to reduce overtreatment of prostate cancer. 2000 men will be randomly allocated to either surveillance according to current practice or to standardised triggers at centres in Sweden, Norway, Finland and the UK. Men diagnosed in the past 12 months with prostate cancer, ≤T2a, prostate-specific antigen (PSA) <15 ng/mL, PSA density ≤0.2 ng/mL/cc, any International Society of Urological Pathology (ISUP) grade 1 are eligible. Men with ISUP grade 2 in <30% of cores on systematic biopsy and <10 mm cancer in one core on systematic or targeted biopsy are also eligible. Men diagnosed on systematic biopsy should have an MRI and targeted biopsies against Prostate Imaging and Reporting Data System V.2 3–5 lesions before inclusion. Identical follow-up in the two study arms: biannual PSA testing, yearly clinical examination and MRI every second year. In the experimental arm, standardised triggers based on MRI and PSA density elicit repeated biopsies. MRI and histopathological progression trigger radical treatment. Primary outcome measure is progression-free survival. Secondary outcome measures are cumulative incidence of metastatic disease, treatments with curative intent, pT3-4 at radical prostatectomy, switch to watchful waiting, prostate cancer mortality and quality of life. Inclusion started in October 2016 and in October 2018; 275 patients have been enrolled.Ethics and disseminationEthical approval was obtained in each participating country. Results for the primary and secondary outcome measures will be submitted for publication in peer-reviewed journals.Trial registration numberNCT02914873.

ObjectiveAlthough surveillance after radical prostatectomy routinely includes repeated prostate specific antigen (PSA)-testing for many years, biochemical recurrence often occurs without further clinical progression. We therefore hypothesised that follow-up can be shortened for many patients without increasing the risk of prostate cancer death. We investigated the long-term probabilities of PSA recurrence, metastases and prostate cancer death in patients without biochemical recurrence five and 10 years after radical prostatectomy.DesignProspective cohort study. Stratification by Gleason score (≤3+4=7 or ≥4+3=7), pathological tumour stage (pT2 or ≥pT3) and negative or positive surgical margins.SettingBetween 1989 and 1998, 14 urological centres in Scandinavia randomised patients to the Scandinavian Prostate Cancer Group study number 4 (SPCG-4) trial.ParticipationAll 306 patients from the SPCG-4 trial who underwent radical prostatectomy within 1 year from inclusion were eligible. Four patients were excluded due to surgery-related death (n=1) or salvage radiotherapy or hormonal treatment within 6 weeks from surgery (n=3).Primary outcome measuresCumulative incidences and absolute differences in metastatic disease and prostate cancer death.ResultsWe analysed 302 patients with complete follow-up during a median of 24 years. Median preoperative PSA was 9.8 ng/mL and median age was 65 years. For patients without biochemical recurrence 5 years after radical prostatectomy the 20-year probability of biochemical recurrence was 25% among men with Gleason score ≤3+4=7 and 57% among men with Gleason score ≥4+3=7; the probabilities for metastases were 0.8% and 17%; and for prostate cancer death 0.8% and 12%, respectively. The long-term probabilities were higher for pT ≥3 versus pT2 and for positive versus negative surgical margins. Limitations include small size of the cohort.ConclusionMany patients with favourable histopathology without biochemical recurrence 5 years after radical prostatectomy could stop follow-up earlier than 10 years after radical prostatectomy.

Background MRI and fusion guided biopsy have an increased role in the diagnosis of prostate cancer. Purpose To demonstrate the possible advantages with Bi-parametric MRI fusion-guided repeat biopsy over systematic 10–12-core biopsy for the diagnosis of prostate cancer. Material and Methods Four hundred and twenty-three consecutive men, with previous systematic 10–12-core TRUS-guided biopsy, and with suspicion of, or diagnosis of, low-risk prostate cancer underwent fusion-guided prostate biopsy between February 2015 and February 2017. The material was retrospectively assessed. In 220 cases no previous cancer was diagnosed, and in 203 cases confirmatory fusion guided biopsy was performed prior to active monitoring. MRI was classified according to PI-RADS. Systematic biopsy was compared to fusion guided biopsy for the detection of cancer, and PI-RADS was compared to the Gleason score. Results Fusion guided biopsy detected significantly more cancers than systematic ( p < .001). Gleason scores were higher in the fusion biopsy group ( p < .001). Anterior tumors were present in 54% of patients. Fusion biopsy from these lesions showed cancer in 53% with previously negative biopsy in systematic biopsies and 66% of them were upgraded from low risk to intermediate or high-risk cancers. Conclusion These results show superior detection rate and grading of bi-parametric MRI/TRUS fusion targeted repeat biopsy over systematic 10–12 core biopsies. Fusion guided biopsy detects more significant cancers despite using fewer cores. The risk group was changed for many patients initially selected for active surveillance due to upgrading of tumors. Bi-parametric MRI shows promising results in detecting anterior tumors in patients with suspected prostate cancer.

Abstract Background To demonstrate possible advantages with Bi-parametric MRI fusion-guided repeat biopsy over systematic 10-12-core biopsy for diagnosis of prostate cancer. Methods All patients who underwent fusion guided biopsy between February 2015 to February 2017 were included. Four hundred twenty-three consecutive men, with previous systematic10-12-core TRUS-guided biopsy, with suspicion of or low-risk prostate cancer underwent fusion-guided prostate biopsy. The material was retrospectively assessed. In 220 cases no previous cancer was diagnosed and in 203 cases confirmatory fusion guided biopsy was performed prior to active monitoring. MRI was done and classified according to PI-RADS. Region of Interest (ROI) was marked. Systematic biopsy was compared to fusion guided biopsy for detection of cancer, as well as PI-RADS was compared to Gleason score. Results Fusion guided biopsy detected significantly more cancers than systematic (p < 0.001). Gleason scores were higher in the fusion biopsy group (p < 0,001). PI-RADS score correlated with the presence of cancer in fusion biopsies. PI-RADS 2 yielded 19% cancer and PI-RADS 3 56%, PI-RADS 4–5 were cancerous in 83%. Only 3 out of 53 biopsies from PI-RADS 2 lesions showed high grade cancer (Gleason score 4 + 3 and higher) compared to 10/133 (7,5%) from PI-RADS 3 lesions and 54/239 (23%) from PI-RADS 4–5. Conclusion These results show superior detection rate and grading of bi-parametric MRI/TRUS fusion targeted repeat biopsy over systematic 10–12 core biopsies. Fusion guided biopsy detects more significant cancers despite using fewer cores. There is significant impact on known cases of low-risk PCa with change of risk group for many patients initially selected for active surveillance.