Furthermore, pre-treatment total testosterone was an independent predictor of extraprostatic disease in patients with localized prostate cancer; as testosterone decreases, patients have an increased likelihood of non-organ confined disease and low serum testosterone levels are associated with positive surgical margins in radical retropubic prostatectomy. A clinical implication of these results concerns androgen supplementation which has become easier to administer with the advent of transdermal preparations (patch or gel) that achieve physiological testosterone serum levels without supra physiological escape levels. During the clinical development of a new testosterone patch in more than 200 primary or secondary hypogonadal patients, no prostate cancer was diagnosed.
(a) TRT in Patients with Untreated PCa. There has been no concrete evidence as of yet. One case report and two studies including 13 and 7 patients have been published on TRT in patients with PCa but did not receive any treatment for it. In the case report, an 84-year-old man with a serum PSA level of ng/mL and a PCa of a Gleason score of 3 + 3 received TRT for 2 years for symptomatic hypogonadism [ 46 ]. As symptoms of hypogonadism regressed, his serum PSA level went down to ng/mL with no evidence of clinical progression of the PCa. The author concluded that this is an important observation which interrogates our perception of the correlation between PCa and TRT despite the fact that this was made only on a single patient. The same author presented his observation on 13 patients with symptomatic hypogonadism and concomitant PCa who elected to go with active surveillance for PCa but received TRT for their hypogonadism [ 47 ]. All patients were evaluated with serum PSA checks and repeat prostate biopsies. Median duration of TRT was years. The mean age was years. Mean serum PSA level and prostate volume did not change with TRT. No local progression and distant metastasis were observed with TRT. These results seem contradictory to the traditional belief that the men with untreated PCa are never given TRT. This study is important for its being the first one carried out on TRT in patients who did not receive active treatment for PCa. In another study by Morales, efficacy of TRT was evaluated in 7 hypogonadal men with untreated PCa. The mean age of the patients was 68 years. Three patients received long-term (33 months, 96 months, and 51 months) TRT. None of the patients had metastatic diseases during TRT even if serum PSA level increased [ 48 ].