RESUMEN
Radiation technique for prostate cancer has continuously evolved over the past several decades. The aim of the present study was to describe the effects of implementing modern prostate intensity-modulated radiation therapy (M-IMRT) on dosimetry and outcome. Between January 2010 and April 2012, 48 consecutive patients were treated with conventional prostate IMRT (C-IMRT) to a dose of 81 Gy. Between May 2012 and April 2015, 50 consecutive patients were treated with M-IMRT to the entire prostate to a dose of 75.6-79.2 Gy, while using prostate magnetic resonance imaging fusion, dose-volume constraints prioritizing normal tissue avoidance above planning target volume coverage, and boosting any dominant intraprostatic masses to 79.2-81 Gy. Rectal Dmax, V75, V60, V65 and V50, bladder Dmax, V75, V70 and V65, and acute and late toxicities were compared between the C-IMRT and M-IMRT groups. The median follow-up for the C-IMRT and M-IMRT groups was 61 vs. 26 months, respectively (P<0.001). M-IMRT resulted in a significant reduction in median rectal Dmax, rectal V75, rectal V70, rectal V65, bladder Dmax, bladder V75, bladder V70 and bladder V65 (P<0.01 for all). There was no significant difference in rectal V50. The 2-year rate of late grade ≥2 rectal bleeding was 13% with C-IMRT vs. 3% with M-IMRT (P=0.03). The 2-year rate of late grade ≥2 genitourinary toxicity was 11% for C-IMRT vs. 5% for M-IMRT (P=0.21). There were no significant differences in acute toxicity, biochemical control or overall survival. Therefore, compared with C-IMRT, M-IMRT was associated with reduced rectal toxicity without compromising disease control.
RESUMEN
Sexual activity, sexual desire, and mood decrease in men with low testosterone levels. The Testim(R) Study of Testosterone Androgen Response Time (START) explored the time to response in sexual activity, desire, and mood following testosterone replacement therapy with Testim for 30 days in 638 hypogonadal men. Response in sexual activity, desire, and mood all improved relative to baseline within the first week of Testim therapy. Patients reached a maximal response by the end of 2 weeks of therapy and maintained the response through 4 weeks of therapy. Frequency of intercourse showed a significant increase after 2 weeks of Testim therapy. Both measures of positive mood and negative mood improved significantly, beginning with the first week of therapy and reaching and maintaining a maximal response at the second week.
RESUMEN
OBJECTIVE: The safety, efficacy, and pharmacokinetics of monthly subcutaneous injections of a new leuprolide acetate (LA) depot formulation were investigated in patients with advanced prostate cancer. METHODS: The 2-part, 6-month (168-day), open-label, multicenter study enrolled male patients diagnosed with adenocarcinoma of the prostate (Jewett stage C or D). LA-2500 7.5-mg (a new subcutaneous depot formulation containing 7.5 mg of LA) injections were administered at monthly (28-day) intervals. The primary efficacy parameter was total serum testosterone level. A breakthrough response was defined as a single testosterone measurement > 50 ng/dL after achieving castration testosterone levels. Testosterone was isolated from sera by alumina column chromatography and measured by radioimmunoassay (RIA). LA was purified by solid-phase extraction and high-performance liquid chromatography and was then quantitated by RIA. RESULTS: One hundred seventeen of the 120 enrolled patients completed the 6-month study. Three patients withdrew for reasons not related to treatment. LA had a mean (SD) maximal concentration of 26.3 (12.6) ng/mL at 4.66 (1.44) hours and was detected for a mean of 37 days (range, 28-49 days). By day 28, 94.1% (112/119) of the patients achieved medical castration (serum testosterone < or = 50 ng/dL). By day 42, 100.0% (118/118) of the patients remaining in the study had serum testosterone levels < or = 50 ng/dL and 97.5% (115/118) had levels < or = 20 ng/dL. At study completion, the mean (SD) serum testosterone level was 6.12 (4.3) ng/dL (range, 3.0-27.0 ng/dL). No breakthrough or acute-on-chronic responses were reported throughout the study. From baseline to month 6, mean (SD) luteinizing hormone level decreased from 8.0 (7.3) mIU/mL to 0.09(0.1) mIU/mL, and mean (SD) prostate-specific antigen level decreased from 32.9 (86.3) ng/mL to 3.2 (12.0) ng/mL. Treatment-related adverse events were reported by 74.2% (89/120) of patients, the most common being hot flashes (56.7%). CONCLUSION: This 6-month, open-label, noncontrolled study showed LA-2500 7.5-mg depot was well tolerated and maintained testosterone suppression (< or = 50 ng/dL) in the patients completing the study without any testosterone breakthrough responses.