Prostate Cancer Incidence in Testosterone-Treated Men versus Untreated Men

Chicago—There is no evidence that the risk of prostate cancer is increased with testosterone treatment in hypogonadal men according to the European Association of Urology (EAU). Ahmad Haider, MD, and Karim Sultan Haider, MD, conducted an analysis of symptomatic men with testosterone ≤350 ng/dL compared with untreated controls. Results were reported during a poster session at the ASCO 2018 Annual Meeting in a poster titled Prostate Cancer (PCa) Incidence and Severity in Hypogonadal Men Treated with Testosterone Compared to Untreated Controls: Experience from 6500 Patient-Years from a Controlled Registry Study.

The treated group included 412 men who received testosterone undecanoate 1000 mg every 3 months following an initial 6-month interval for up to 12 years. The control group included 393 hypogonadal men who decided against testosterone treatment; age of the men in the control group ranged from 51 to 74 years. Total observation time covered approximately 6500 patient-years. Prior to initiation of treatment/observation, prostate cancer was excluded by transrectal ultrasound, digital rectal examination, and prostate-specific antigen (PSA) measurement. Examinations were repeated between one and four times per year; when indicated by EAU guidelines, biopsies were performed.

In the testosterone group, 2.7% (n=11) men were diagnosed with prostate cancer, compared with 8.9% (n=35) in the control group. The mean baseline age of men diagnosed with prostate cancer was 65.3 years in the testosterone group and 63.7 years in the control group. The average time span between the day of first injection and positive biopsy in the testosterone group was 386 days; prostate cancer was diagnosed at any time during the observation period in the control group.

Radical prostatectomy was performed in all men in the testosterone group; all but two patients had a Gleason score ≤6 and all had a primary Gleason score of 3. In all 11 men with prostate cancer in the testosterone group, tumor grade was G2; tumor stage was T2a in 64% (n=7) and T2c in 9% (n=1).

In the control group, radical prostatectomy was performed in all but six patients; those six received radiation therapy. Seven patients received both radical prostatectomy and radiation therapy. Gleason score was ≤6 in two patients, seven had Gleason score of 7, 16 had a Gleason score of 8, and 10 had a Gleason score of 9. Four men had a primary Gleason score of 3, 22 a primary Gleason score of 4, and nine a primary Gleason score of 5. In eight patients (22.9%), tumor grade was G2; tumor grade was G3 in 27 (77.1%) of patients. Tumor stage was T2a in two patients (5.7%), T2c in one (2.0%), and T3b (37.1%) in 13 patients.

Biochemical recurrence occurred in 10 patients (28.6%) in the control group. Those 10 patients received androgen deprivation therapy (ADT). Twelve patients in the control group died; seven of the 12 were on ADT.

There were no biochemical recurrences or deaths in the testosterone group during the observation time.

“Prostate cancer incidence and severity in testosterone-treated hypogonadal patients were less compared to untreated hypogonadal controls,” the researchers concluded.

Source: Haider A, Haider KS. Prostate cancer (PCa) incidence and severity in hypogonadal men treated with testosterone compared to untreated controls: Experience from 6500 patient-years from a controlled registry study. Abstract of a poster presented at the American Society of Clinical Oncology 2018 Annual Meeting, June 2, 2018, Chicago, Illinois.