| 1. |
- Rosen, Raymond C., et al.
(author)
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Quality of Life and Sexual Function Benefits of Long-Term Testosterone Treatment : Longitudinal Results From the Registry of Hypogonadism in Men (RHYME)
- 2017
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In: Journal of Sexual Medicine. - : WILEY. - 1743-6095 .- 1743-6109. ; 14:9, s. 1104-1115
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Journal article (peer-reviewed)abstract
- Background: The benefits and risks of long-term testosterone administration have been a topic of much scientific and regulatory interest in recent years. Aim: To assess long-term quality of life (QOL) and sexual function benefits of testosterone replacement therapy (TRT) prospectively in a diverse, multinational cohort of men with hypogonadism. Methods: A multinational patient registry was used to assess long-term changes associated with TRT in middle-age and older men with hypogonadism. Comprehensive evaluations were conducted at 6, 12, 24, and 36 months after enrollment into the registry. Outcomes: QOL and sexual function were evaluated by validated measures, including the Aging Males' Symptom (AMS) Scale and the International Index of Erectile Function (IIEF). Results: A total of 999 previously untreated men with hypogonadism were enrolled at 25 European centers, 750 of whom received TRT at at least one visit during the period of observation. Patients on TRT reported rapid and sustained improvements in QOL, with fewer sexual, psychological, and somatic symptoms. Modest improvements in QOL and sexual function, including erectile function, also were noted in RHYME patients not on TRT, although treated patients showed consistently greater benefit over time in all symptom domains compared with untreated patients. AMS total scores for patients on TRT were 32.8 (95% confidence interval = 31.3-34.4) compared with 36.6 (95% confidence interval = 34.8-38.5) for untreated patients (P < .001). Small but significant improvements in IIEF scores over time also were noted with TRT. Approximately 25% of treated and untreated men also used phosphodiesterase type 5 inhibitors, with notable differences in the frequency of phosphodiesterase type 5 inhibitor prescription use according to physician specialty and geographic site location. Clinical Implications: TRT-related benefits in QOL and sexual function are well maintained for up to 36 months after initiation of treatment. Strengths and Limitations: The major strengths are the large, diverse patient population being treated in multidisciplinary clinical settings. The major limitation is the frequency of switching from one formulation to another. Conclusion: Overall, we confirmed the broad and sustained benefits of TRT across major QOL dimensions, including sexual, somatic, and psychological health, which were sustained over 36 months in our treatment cohort. Copyright (C) 2017, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
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| 2. |
- Azzouzi, Abdel Rahmène, et al.
(author)
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Padeliporfin vascular-targeted photodynamic therapy versus active surveillance in men with low-risk prostate cancer (CLIN1001 PCM301) : An open-label, phase 3, randomised controlled trial
- 2017
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In: The Lancet Oncology. - 1470-2045. ; 18:2, s. 181-191
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Journal article (peer-reviewed)abstract
- Background: Vascular-targeted photodynamic therapy, a novel tissue-preserving treatment for low-risk prostate cancer, has shown favourable safety and efficacy results in single-arm phase 1 and 2 studies. We compared this treatment with the standard of care, active surveillance, in men with low-risk prostate cancer in a phase 3 trial. Methods: This randomised controlled trial was done in 47 European university centres and community hospitals. Men with low-risk, localised prostate cancer (Gleason pattern 3) who had received no previous treatment were randomly assigned (1:1) to vascular-targeted photodynamic therapy (4 mg/kg padeliporfin intravenously over 10 min and optical fibres inserted into the prostate to cover the desired treatment zone and subsequent activation by laser light 753 nm with a fixed power of 150 mW/cm for 22 min 15 s) or active surveillance. Randomisation was done by a web-based allocation system stratified by centre with balanced blocks of two or four patients. Best practice for active surveillance at the time of study design was followed (ie, biopsy at 12-month intervals and prostate-specific antigen measurement and digital rectal examination at 3-month intervals). The co-primary endpoints were treatment failure (histological progression of cancer from low to moderate or high risk or death during 24 months' follow-up) and absence of definite cancer (absence of any histology result definitely positive for cancer at month 24). Analysis was by intention to treat. Treatment was open-label, but investigators assessing primary efficacy outcomes were masked to treatment allocation. This trial is registered with . ClinicalTrials.gov, number . NCT01310894. Findings: Between March 8, 2011, and April 30, 2013, we randomly assigned 206 patients to vascular-targeted photodynamic therapy and 207 patients to active surveillance. Median follow-up was 24 months (IQR 24-25). The proportion of participants who had disease progression at month 24 was 58 (28%) of 206 in the vascular-targeted photodynamic therapy group compared with 120 (58%) of 207 in the active surveillance group (adjusted hazard ratio 0·34, 95% CI 0·24-0·46; p<0·0001). 101 (49%) men in the vascular-targeted photodynamic therapy group had a negative prostate biopsy result at 24 months post treatment compared with 28 (14%) men in the active surveillance group (adjusted risk ratio 3·67, 95% CI 2·53-5·33; p<0·0001). Vascular-targeted photodynamic therapy was well tolerated. The most common grade 3-4 adverse events were prostatitis (three [2%] in the vascular-targeted photodynamic therapy group . vs one [<1%] in the active surveillance group), acute urinary retention (three [2%] . vs one [<1%]) and erectile dysfunction (two [1%] . vs three [1%]). The most common serious adverse event in the vascular-targeted photodynamic therapy group was retention of urine (15 patients; severe in three); this event resolved within 2 months in all patients. The most common serious adverse event in the active surveillance group was myocardial infarction (three patients). Interpretation: Padeliporfin vascular-targeted photodynamic therapy is a safe, effective treatment for low-risk, localised prostate cancer. This treatment might allow more men to consider a tissue-preserving approach and defer or avoid radical therapy. Funding: Steba Biotech.
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| 3. |
- Miller, Kurt, et al.
(author)
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The continuing role of PSA in the detection and management of prostate cancer
- 2007
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In: European Urology. Supplement. - : Elsevier BV. - 1569-9056. ; 6:3, s. 327-333
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Journal article (peer-reviewed)abstract
- Despite being used extensively for the diagnosis and management of prostate cancer, prostate-specific antigen (PSA) testing remains controversial. Doubts have been raised over the continued use of PSA in the detection of clinically significant prostate cancer because many men now present with early-stage, small-volume tumours. This article examines the limitations of using a single PSA value in diagnosis and discusses alternative approaches to PSA testing, in particular PSA velocity and PSA doubling time, which are now emerging as valuable pretreatment disease predictors. A clinical scenario is also presented to illustrate the use of PSA kinetics in identifying candidates for biopsy. (c) 2006 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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| 4. |
- Ruijter, Emiel Th, et al.
(author)
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Rapid microwave-stimulated fixation of entire prostatectomy specimens
- 1997
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In: Journal of Pathology. - 0022-3417. ; 183:3, s. 369-375
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Journal article (peer-reviewed)abstract
- Conventional fixation of large solid surgical specimens is a slow process. Consequently, autolytic damage to tissues may occur if the fixative does not reach the central part of the specimen in time. However, as there is also a time relationship between formalin fixation and antigen masking, fixation for too long can also be detrimental. In seeking the optimum balance for fixation, microwave irradiation might be of assistance. This study set out to evaluate methods for fixing entire prostate glands within a brief period of time, using microwave-stimulated formalin fixation. The results show that entire prostates can be optimally fixed if formalin is present throughout the tissue as the temperature is increased by microwave irradiation. This is achieved by injecting the fixative into the prostate at multiple sites immediately following prostatectomy. The technique described ensures standardization of a critical step during tissue processing, leading to uniform microscopic results with both routine and immunohistochemical stains. It is a simple, rapid method, suitable for routine diagnostic use. Using this modified approach, DNA of much larger sizes can be extracted from paraffin-embedded material, which could expand the possibilities for molecular analysis.
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