Using a contingent of 62 patients of which 46 were BPH and 16 were PCa, we report definitive concentrations of uPA and PAI-1 in tumour tissue extracts and show that the uPA/PAI-1 ratio emerges as a candidate marker to distinguish between BPH and PCa.

Background A resection with clear margins (R0 resection) is the most important prognostic factor in patients with locally recurrent rectal cancer (LRRC). However, this is achieved in only 60 per cent of patients. The aim of this study is to investigate whether the addition of induction chemotherapy to neoadjuvant chemo(re)irradiation improves the R0 resection rate in LRRC. Methods This multicentre, international, open-label, phase III, parallel-arms study will enrol 364 patients with resectable LRRC after previous partial or total mesorectal resection without synchronous distant metastases or recent chemo- and/or radiotherapy treatment. Patients will be randomized to receive either induction chemotherapy (three 3-week cycles of CAPOX (capecitabine, oxaliplatin), four 2-week cycles of FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) or FOLFORI (5-fluorouracil, leucovorin, irinotecan)) followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm). Tumours will be restaged using MRI and, in the experimental arm, a further cycle of CAPOX or two cycles of FOLFOX/FOLFIRI will be administered before chemoradiotherapy in case of stable or responsive disease. The radiotherapy dose will be 25 × 2.0 Gy or 28 × 1.8 Gy in radiotherapy-naive patients, and 15 × 2.0 Gy in previously irradiated patients. The concomitant chemotherapy agent will be capecitabine administered twice daily at a dose of 825 mg/m2 on radiotherapy days. The primary endpoint of the study is the R0 resection rate. Secondary endpoints are long-term oncological outcomes, radiological and pathological response, toxicity, postoperative complications, costs, and quality of life. Discussion This trial protocol describes the PelvEx II study. PelvEx II, designed as a multicentre, open-label, phase III, parallel-arms study, is the first randomized study to compare induction chemotherapy followed by neoadjuvant chemo(re)irradiation and surgery with neoadjuvant chemo(re)irradiation and surgery alone in patients with locally recurrent rectal cancer, with the aim of improving the number of R0 resections.

Objective: To assess the prevalence, onset, duration and severity of hot flashes in men after bilateral orchidectomy (BO) for prostate cancer, to evaluate body temperature changes during hot flashes and to determine whether an elevated temperature within a few days after BO can be caused by deprivation of androgen. Materials and Methods: Patients (n = 101) were questioned about the characteristics of their hot flashes after BO for prostate cancer. A subgroup of these men (n = 17) were instructed to record their oral and forehead temperatures during and at fixed intervals between hot flashes daily for 4 weeks. Results: The mean age was 71.6 years, mean follow-up after BO was 33.2 months. Hot flashes were reported by 87 men (86%) with previous spontaneous remission in 9 (10%). The median time between BO and the onset of hot flashes was 21 days (range 1-730), median number of hot flashes 3 per day (range 1-20), and median duration was 120 seconds (range 5 to 1800). There was no significant difference between median oral (36.4 o C) and forehead (36.0 o C) temperature in the normal state, but during hot flashes the median forehead temperature (37.0 o C) was higher than the oral temperature (36.5 o C) (p = 0.0004). Both median oral and forehead temperatures were higher during hot flashes (36.5 o C and 37.0 o C) than in the normal state (36.4 o C and 36.0 o C, respectively) (p < 0.0001). During hot flashes, the oral temperature was 38 o C to 40 o C in only 3.2% of 593 readings in 17 patients. Conclusions: The median oral and forehead temperatures are higher during hot flashes than in normal periods. Oral temperature elevation > 38 o C within days after a BO is unlikely to be the result of androgen deprivation alone.

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