Prostate cancer incidence in hypogonadal men on long-term treatment with testosterone undecanoate injections.

17 Background: Concerns regarding the safety of testosterone treatment, particularly regarding prostate cancer (PCa) in middle-aged and elderly men, still hamper the use of testosterone in hypogonadal men. In this study, we investigated prostate parameters incl. incidence of PCa in hypogonadal patients on long-term treatment with TU. Methods: In a prospective, cumulative registry study, 340 men (age: 57.37 ± 7.03 years) with testosterone ≤12.1 nmol/L received TU 1,000 mg every 12 weeks following an initial interval of 6 weeks for up to 7 years. Prostate volume (PV) and PSA were measured and digital rectal examination (DRE)/ transrectal ultrasound (TRUS) performed before treatment initiation and then regularly every 3-6 months. In case of suspected PCa, biopsies were performed. Results: PV increased from 28.96 ± 10.41 to 29.88 ± 13.85 ml by model-adjusted 2.59 ± 0.2 ml (p<0.0001). This increase was statistically significant compared to the previous year for the first four years. PSA increased from 1.74 ± 0.94 to 1.96 ± 1.03 ng/ml by model-adjusted 0.23 ± 0.52 ng/ml (p<0.0001). 53 biopsies were performed in testosterone-treated patients. Of these, 5 (9.4%) were positive and 48 (90.6%) negative. The proportion of PCa in testosterone-treated patients in our registry study was 1.5% with an incidence of 30.7 per 10,000 patient years. In hypogonadal patients without testosterone treatment, 314 biopsies were performed. Of these, 111 (35.4%) were positive and 203 (64.6%) negative. In eugonadal patients, 584 biopsies were performed. Of these, 263 (40.4%) were positive and 321 (55%) negative. In total, 951 prostate biopsies were performed in our practice from 2004 through 2013, of which 379 (39.9%) were positive and 572 (60.1%) negative. Conclusions: Long-term treatment with TU in hypogonadal men undergoing regular monitoring according to EAU guidelines does not increase the incidence of PCa.

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Incidence and severity of prostate cancer in 360 hypogonadal men treated with testosterone undecanoate injections (TU) for up to 8 years and 296 untreated hypogonadal controls.

Journal of Clinical Oncology ◽

10.1200/jco.2016.34.2_suppl.50 ◽

2016 ◽

Vol 34 (2_suppl) ◽

pp. 50-50

Author(s):

Ahmad Haider ◽

Karim Sultan Haider

Keyword(s):

Prostate Cancer ◽

Lymph Nodes ◽

Gleason Score ◽

Term Treatment ◽

Control Group ◽

Registry Study ◽

Testosterone Undecanoate ◽

Ctrl Group ◽

Long Term Treatment

50 Background: Testosterone therapy (TTh) in middle-aged and elderly men is still associated with concerns regarding prostate cancer (PCa). In this registry study, we investigated the incidence of PCa in hypogonadal patients on long-term treatment with TU in comparison to an untreated hypogonadal control group (CTRL). Methods: In a cumulative registry study, 360 men (mean age: 57.37±7.29 years, range: 33-70) with testosterone (T) ≤12.1 nmol/L received TU 1000 mg every 12 weeks following an initial interval of 6 weeks for up to 8 years. 296 hypogonadal men (mean age: 64.79±4.28 years, range: 57-74) decided against TTh, mainly due to financial reasons. Prostate volume (PV) and PSA were measured and digital rectal examination (DRE)/ transrectal ultrasound (TRUS) performed before treatment initiation and then regularly every 3-6 months. Biopsies were performed when indicated according to EAU guidelines. Results: From baseline to 8 years, PV increased from 29.24±10.38 to 31.13±11.45 ml in the T group and remained stable from 34.45±5.89 to 33.51±12 in CTRL. PSA increased slightly from 1.74 ± 0.93 to 1.83±0.93 ng/ml in the T group and remained stable from 2.25±1.34 to 2.19±1.17 in CTRL. In T-treated patients, 7 men (1.9%) were diagnosed with PCa. In the control group, 12 (4.1%) were diagnosed with PCa. The incidence per 10,000 years was 30.05 in the T group and 63.54 in CTRL. The mean age of PCa patients was 64 years in the T group and 65 years in CTRL. All patients underwent radical prostatectomy. The predominant Gleason score was 3 in all patients in the T group, lymph nodes and surgical margins were negative. In CTRL, three men had a predominant Gleason score of 3, 8 had 4, and 1 had 5. 7 patients had positive lymph nodes and no patient had a positive surgical margin. Conclusions: Long-term treatment with TU in hypogonadal men undergoing regular monitoring according to EAU guidelines does not increase the incidence of PCa in comparison to an untreated hypogonadal CTRL group. PCa was more severe in the CTRL group.

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