Look over post #19
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Take home-point here!
Prostate cancer (PCa)
*Recent literature does not support an increased risk of PCa in hypogonadal men undergoing testosterone therapy. Although it is mandatory to avoid testosterone administration in men with advanced PCa, insufficient long-term prospective data on the safety of testosterone therapy in PCa survivors [144], should prompt caution in choosing to treat symptomatic hypogonadal men in this setting
EAU GUIDELINES ON SEXUAL AND REPRODUCTIVE HEALTH - LIMITED UPDATE APRIL 2024
3.5 Safety and follow-up in hypogonadism management
3.5.4 Prostate cancer (PCa)
A considerable number of observational studies have failed to demonstrate any association between circulating higher testosterone levels and PCa [138]. In contrast, studies investigating the relationship between low levels of testosterone and risk of PCa have found that men with very low levels of fT have a reduced risk of developing low-to-intermediate-grade PCa, but have a non-significantly increased chance of developing high-grade PCa[138]. This peculiar pattern was also reported in trials such as the Health Professionals Follow-up Study, the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE),with varying magnitudes of significance [139].
A meta-analysis, including 27 placebo-controlled, RCTs, found no evidence of increased PSA levels following testosterone therapy for one-year. When considering eleven studies reporting on the occurrence of PCa, the meta-analysis found no evidence of increased risk of PCa. However, a one year follow-up may be considered too short to draw firm conclusions on the risks of developing PCa. Furthermore, the analysis was restricted to studies with > 1-year follow-up, but no significant changes in PSA levels nor increased risk of PCa were found [132]. After five-year of median follow-up in three independent registry studies with > 1,000 patients undergoing testosterone therapy, PCa occurrence always remained below the reported incidence rate in the general population [140]. Similar results were reported by a large observational study including 10,311 mentreated with testosterone therapy and 28,029 controls with a median follow-up of 5.3 years [141]. The same study, also showed that the risk of PCa was decreased for men in the highest tertile of testosterone therapy cumulative dose exposure as compared with controls [141].
Recently, the TRAVERSE study, a multicenter, randomized, double-blind, placebo-controlled, noninferiority trial involving 5246 men aged 45 to 80 years, who had pre-existing or a high risk of CVD and who have been treated because of low testosterone levels (i.e., total T < 10.4 nmol/L) associated with reported symptoms of hypogonadism, did not show any difference in terms of PCa incidence or high-grade PCa rate between arms (testosterone therapy vs. placebo) at a mean follow-up, was 33.0± (SD) 12.1 months. Conversely, the same trial showed a significantly greater increase from baseline of total PSA in the treatment group as compared with the placebo arm [77].
With regards to PCa survivors, safety in terms of the risk of recurrence and progression has not yet been established. Limited data are available in the literature, with most case series not providing sufficient data to draw definitive conclusions (e.g., insufficient follow-up, small samples, lack of control arms, heterogeneity in study population and treatment regimen, etc.) [142]. A meta-analysis derived from thirteen studies including 608 patients, of whom 109 had a history of high-risk PCa, with follow-up of 1-189.3 months [143], suggested that testosterone therapy did not increase the risk of biochemical recurrence, but the available evidence is poor,limiting data interpretation [143]. Similar considerations can be derived from another, larger meta-analysis of 21 studies [144]. However, it is important to recognise both meta-analyses demonstrated high heterogeneity among the different studies and included a limited number of subjects. An RCT assessing the safety/benefit ratio of testosterone therapy in hypogonadal men successfully treated with prostatectomy for non-aggressive prostate PCa is currently ongoing [145].
In conclusion, recent literature does not support an increased risk of PCa in hypogonadal men undergoing testosterone therapy. Although it is mandatory to avoid testosterone administration in men with advanced PCa, insufficient long-term prospective data on the safety of testosterone therapy in PCa survivors [144], should prompt caution in choosing to treat symptomatic hypogonadal men in this setting. In particular, patients should receive comprehensive counselling regarding the uncertain long-term effects of testosterone therapy in this context, which necessitates further investigation. Due to the lack of strong evidence-based data on safety, the possible use of testosterone therapy in symptomatic hypogonadal men previously treated for PCa should be fully discussed with patients and limited to low-risk individuals.
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D. CONCLUSIONS
In middle-aged and older men with hypogonadism, who have been carefully screened to exclude those at high risk of prostate cancer or with severe lower urinary tract symptoms, the incidences of high grade or any prostate cancer, acute urinary retention, invasive surgical procedure on the benign prostatic hyperplasia, prostate biopsy, or initiation of new pharmacologic therapy for lower urinary tract symptoms are low. These findings should be viewed in the context of the small number of prostate cancer events in the testosterone studies, the relatively short treatment duration of the trials relative to the long time it may take for carcinogens to induce cancer, and the exclusion of men at high risk for prostate cancer in these trials. A baseline evaluation of prostate cancer risk and implementation of a standardized monitoring plan to minimize the risk of unnecessary prostate biopsies while enabling the detection of high -grade prostate cancers and other prostate safety events, can help optimize the benefit to risk ratio in men receiving TRT. Because PSA screening and monitoring has the potential for harm, the decision to implement PSA monitoring should be made jointly by the patient and the clinician.
What the TRAVERSE Trial did and did not show
At its core, the TRAVERSE Trial shows that TRT of middle-aged and older men with hypogonadism with a PSA <3.0 ng/mL, who had been screened carefully to exclude those at high risk of prostate cancer, is associated with low risk of high grade or any prostate cancer. Several caveats apply to this inference. First, because the numbers and incidence of high grade or any prostate cancer in the two groups were very low, these data should not be interpreted to mean that the incidence was similar in the two groups. Second, even though TRAVERSE is among the longest and the largest trials of TRT, with 14,304 person -23 years of follow-up and an average follow-up duration of 33 months, carcinogens typically take a long period of time to cause cancer. Long-term differences in risk of prostate cancer in men receiving testosterone or placebo are unknown. Third, in line with American Urological Association/Society of Urologic Oncology (AUA/SUO) guidelines, an elevated PSA was repeated in all men prior to consideration of further evaluation (49,50). Additionally, men were provided access to a standardized informational video about the potential benefits and risks of prostate biopsy to ensure shared decision-making regarding their desire for further evaluation. These steps likely reduced the number of persons undergoing prostate biopsy. Fourth, prostate imaging or genetic testing studies were not performed as part of the evaluation; it is possible that the availability of these additional diagnostic studies could have changed the decision to perform prostate biopsy. Finally, men at increased risk of prostate cancer were excluded from the trial; the trial's findings do not apply to men at high risk of prostate cancer.
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Look over post # 14/15/16
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T Therapy in men with PCa!
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