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1379 PSA LEVELS SIGNIFICANTLY RISE AFTER 3 MONTHS OF TESTOSTERONE REPLACEMENT THERAPY IN SEVERELY HYPOGONADAL MEN IN THE TESTIM REGISTRY IN THE US (TRIUS) COHORT
Vol. 183, No. 4, Supplement, Tuesday, June 1, 2010
THE JOURNAL OF UROLOGY姞
e533
1379
1380
PSA LEVELS SIGNIFICANTLY RISE AFTER 3 MONTHS OF TESTOSTERONE REPLACEMENT THERAPY IN SEVERELY HYPOGONADAL MEN IN THE TESTIM REGISTRY IN THE US (TRIUS) COHORT
THE EFFECTIVENESS OF CLOMIPHENE CITRATE THERAPY FOR LATE-ONSET HYPOGONADISM(LOH)
Mohit Khera*, Houston, TX; Martin Miner, Providence, RI; Rajib Bhattacharya, Kansas City, KS; Gary Blick, Norwalk, CT; Harvey Kushner, Dat Nguyen, Malvern, PA INTRODUCTION AND OBJECTIVES: The prostate saturation theory suggests that lower testosterone (T) values are more likely to correlate with changes in PSA values and prostate growth than higher levels of T. We studied T and PSA values in hypogonadal men enrolled in TRiUS at baseline and reported that lower PSA values were associated with lower serum T levels. We reevaluated these correlations at 6 months following treatment. METHODS: At baseline, serum PSA and T levels were available for 449 of the 849 men. 6-month follow up data were analyzed to revaluate correlations between serum T and PSA. Hypogonadal men were grouped based on baseline T levels: ⬍250 ng/dL and ⱖ250 ng/dL and further stratified as follows: serum T values of ⬍150 ng/dL (Group I), 150-200 ng/dL (Group II), and 201-249 ng/dL (Group III). Spearman correlation coefficients with PSA values were assessed. Changes in mean PSA values and T levels were assessed using t-tests. RESULTS: Baseline serum PSA and T levels were available for 449 men (mean age 54.5⫾11.7) who had mean total and free T values of 285.1⫾130.2 ng/dL and 42.2⫾38.0 pg/dL, and the mean PSA value was 1.12⫾1.1 ng/mL. Of these 449 men, 198 (mean age 55; R, 28-83) had total serum T values ⬍250 ng/dL. Mean total and free T values were 187 ng/dL and 29.6 pg/dL. The mean PSA value was 1.04 ng/mL. Mean PSA values significantly correlated with serum total T values (r⫽0.21, p⫽0.0032) and with serum free T and SHBG levels (r⫽0.20, p⫽0.04 and r⫽0.59, p⫽0.002). Mean PSA values differed significantly (p⫽0.02) among Groups I (0.86, n⫽40), II (0.88, n⫽62), and III (1.22, n⫽96). At 6 months, T and PSA levels were available for 100 men. Mean serum T was 453⫾225 ng/dL and mean PSA was 1.46⫾1.62 ng/mL. There were no significant changes from 3 months to 6 months in PSA or T values (Table 1). The changes from baseline to 6 months in serum total T and PSA were 192⫾213 ng/dL (p⬍0.0001) and 0.29⫾0.90 ng/mL (p⫽0.002). CONCLUSIONS: At baseline, PSA values appear to significantly correlate with serum total and free T and SHBG levels in hypogonadal men, but not in eugonadal men. A significant rise in PSA levels are seen at 3 months after initiating TRT. However, PSA values do not continue to rise after 3 months, supporting the prostate saturation theory.
Baseline Month 3
Month 6
Table 1. Total PSA Testosterone Days Mean ⴞSD Mean ⴞSD from (ng/mL) (ng/dL) Baseline 261.3⫾116.1 1.17⫾1.34 88⫾37
199⫾41
N⫽100
N⫽100
482.5⫾262.9
1.94⫾2.04
N⫽40
N⫽40
453.5⫾224.9
1.46⫾1.62
N⫽100
N⫽100
Toshihiro Tai*, Koichi Nagao, Tokyo, Japan; Koichi Nakajima, Takao Ishiwatari, Yusuke Oka, Shigeki Kanbe, Masato Nagata, Fumito Yamabe, Keiichiro Takasugi, Shuichi Kamimura, Taisuke Suyama, Hideyuki Kobayashi, Kuri Suzuki, Norie Tanaka, Hiroshi Hara, Kazukiyo Miura, Nobuhisa Ishii, Ota-ku, Japan; Makoto Fujime, Tokyo, Japan INTRODUCTION AND OBJECTIVES: Late-Onset Hypogonadism(LOH) is typically treated with an androgen preparation. In an assessment of the effectiveness of clomiphene citrate therapy for men with oligozoospermia, sperm motility and serum testosterone level were improved after treatment. We therefore investigated the effectiveness of clomiphene citrate therapy for LOH. METHODS: We reviewed the records of 251 men (mean age⫾SD, 35⫾5.058; range, 25-65 years) with idiopathic oligozoospermia and normal FSH levels who were treated at the Center for Reproductive Medicine at Toho University Omori Hospital from 1998 through 2009. We excluded patients with abnormalities of the ground substance (such as obstructive azoospermia, hormonal abnormalities, or genetic disorders). The patients were treated with 25 mg or 50 mg clomiphene citrate for a period of 3 months to 1 year. Levels of testosterone LH, FSH, and PRL were measured. RESULTS: As compared to baseline, testosterone, LH, and FSH were significantly improved after treatment in both dosage groups. In the group with a baseline serum testosterone level lower than 300 ng/dl, the average testosterone level increased from 265 to 637 ng/dl (p⬍0.001) in the 25-mg dose group and from 239 to 653 ng/dl (p⬍0.001) in the 50-mg dose group. In the group with a baseline serum testosterone level higher than 300 ng/dl, the average testosterone level increased from 482 to 867 ng/dl (p⬍0.001) in the 25-mg group, and from 475 to 867 ng/dl (p⬍0.001) in the 50-mg group). Three patients who reported depression at baseline experienced improvement in that condition after clomiphene citrate therapy. Adverse effects included male pattern alopecia (5 cases in 50-mg group, 1 case in 25-mg group) and gynecomastia (1 case in 50-mg group). These adverse effects disappeared after stopping treatment. Four patients in the 50-mg dose group developed minor elevations of GOT, GPT, but treatment was successfully continued. CONCLUSIONS: Clomiphene citrate therapy significantly improved serum testosterone level, which suggests that it may be effective for the treatment of LOH. Source of Funding: None
Change in Change Testosterone in PSA
1381
213.9⫾231.2 0.30⫾0.67
THE CHARACTERISTICS AND PREDICTIVE FACTORS OF NONRESPONDER TO TESTOSTERONE REPLACEMENT THERAPY IN TESTOSTERONE DEFICIENCY SYNDROME
N⫽40, P⬍0.0001
N⫽40, P⫽0.007
192.1⫾212.8 0.29⫾0.90 N⫽100, P⬍0.0001
Source of Funding: Auxilium Pharmaceuticals, Inc.
N⫽100, P⫽0.002
Min Gu Park, Mi Mi Oh, Dong Soo Lee, Jeong Wu Yu, Jae Hyun Bae, Seoul, Korea, Republic of; Yong Woo Kim, Suwon, Korea, Republic of; Je Jong Kim, Du Geon Moon*, Seoul, Korea, Republic of INTRODUCTION AND OBJECTIVES: To analyze characteristics of nonresponder to testosterone replacement therapy (TRT) and find out the predictive factors of nonresponder. METHODS: From 2006 to 2008, a total of 200 TDS patients who had been treated over 30 weeks with testosterone undecanoate (TU, Nebido®) were enrolled. Non-response to TRT (Gr I, n⫽47) was defined as the patients who answered as ⬘no symptom improvement⬘ at 30 weeks after TRT and the others were defined as the response group
THE JOURNAL OF UROLOGY姞
e533
1379
1380
PSA LEVELS SIGNIFICANTLY RISE AFTER 3 MONTHS OF TESTOSTERONE REPLACEMENT THERAPY IN SEVERELY HYPOGONADAL MEN IN THE TESTIM REGISTRY IN THE US (TRIUS) COHORT
THE EFFECTIVENESS OF CLOMIPHENE CITRATE THERAPY FOR LATE-ONSET HYPOGONADISM(LOH)
Mohit Khera*, Houston, TX; Martin Miner, Providence, RI; Rajib Bhattacharya, Kansas City, KS; Gary Blick, Norwalk, CT; Harvey Kushner, Dat Nguyen, Malvern, PA INTRODUCTION AND OBJECTIVES: The prostate saturation theory suggests that lower testosterone (T) values are more likely to correlate with changes in PSA values and prostate growth than higher levels of T. We studied T and PSA values in hypogonadal men enrolled in TRiUS at baseline and reported that lower PSA values were associated with lower serum T levels. We reevaluated these correlations at 6 months following treatment. METHODS: At baseline, serum PSA and T levels were available for 449 of the 849 men. 6-month follow up data were analyzed to revaluate correlations between serum T and PSA. Hypogonadal men were grouped based on baseline T levels: ⬍250 ng/dL and ⱖ250 ng/dL and further stratified as follows: serum T values of ⬍150 ng/dL (Group I), 150-200 ng/dL (Group II), and 201-249 ng/dL (Group III). Spearman correlation coefficients with PSA values were assessed. Changes in mean PSA values and T levels were assessed using t-tests. RESULTS: Baseline serum PSA and T levels were available for 449 men (mean age 54.5⫾11.7) who had mean total and free T values of 285.1⫾130.2 ng/dL and 42.2⫾38.0 pg/dL, and the mean PSA value was 1.12⫾1.1 ng/mL. Of these 449 men, 198 (mean age 55; R, 28-83) had total serum T values ⬍250 ng/dL. Mean total and free T values were 187 ng/dL and 29.6 pg/dL. The mean PSA value was 1.04 ng/mL. Mean PSA values significantly correlated with serum total T values (r⫽0.21, p⫽0.0032) and with serum free T and SHBG levels (r⫽0.20, p⫽0.04 and r⫽0.59, p⫽0.002). Mean PSA values differed significantly (p⫽0.02) among Groups I (0.86, n⫽40), II (0.88, n⫽62), and III (1.22, n⫽96). At 6 months, T and PSA levels were available for 100 men. Mean serum T was 453⫾225 ng/dL and mean PSA was 1.46⫾1.62 ng/mL. There were no significant changes from 3 months to 6 months in PSA or T values (Table 1). The changes from baseline to 6 months in serum total T and PSA were 192⫾213 ng/dL (p⬍0.0001) and 0.29⫾0.90 ng/mL (p⫽0.002). CONCLUSIONS: At baseline, PSA values appear to significantly correlate with serum total and free T and SHBG levels in hypogonadal men, but not in eugonadal men. A significant rise in PSA levels are seen at 3 months after initiating TRT. However, PSA values do not continue to rise after 3 months, supporting the prostate saturation theory.
Baseline Month 3
Month 6
Table 1. Total PSA Testosterone Days Mean ⴞSD Mean ⴞSD from (ng/mL) (ng/dL) Baseline 261.3⫾116.1 1.17⫾1.34 88⫾37
199⫾41
N⫽100
N⫽100
482.5⫾262.9
1.94⫾2.04
N⫽40
N⫽40
453.5⫾224.9
1.46⫾1.62
N⫽100
N⫽100
Toshihiro Tai*, Koichi Nagao, Tokyo, Japan; Koichi Nakajima, Takao Ishiwatari, Yusuke Oka, Shigeki Kanbe, Masato Nagata, Fumito Yamabe, Keiichiro Takasugi, Shuichi Kamimura, Taisuke Suyama, Hideyuki Kobayashi, Kuri Suzuki, Norie Tanaka, Hiroshi Hara, Kazukiyo Miura, Nobuhisa Ishii, Ota-ku, Japan; Makoto Fujime, Tokyo, Japan INTRODUCTION AND OBJECTIVES: Late-Onset Hypogonadism(LOH) is typically treated with an androgen preparation. In an assessment of the effectiveness of clomiphene citrate therapy for men with oligozoospermia, sperm motility and serum testosterone level were improved after treatment. We therefore investigated the effectiveness of clomiphene citrate therapy for LOH. METHODS: We reviewed the records of 251 men (mean age⫾SD, 35⫾5.058; range, 25-65 years) with idiopathic oligozoospermia and normal FSH levels who were treated at the Center for Reproductive Medicine at Toho University Omori Hospital from 1998 through 2009. We excluded patients with abnormalities of the ground substance (such as obstructive azoospermia, hormonal abnormalities, or genetic disorders). The patients were treated with 25 mg or 50 mg clomiphene citrate for a period of 3 months to 1 year. Levels of testosterone LH, FSH, and PRL were measured. RESULTS: As compared to baseline, testosterone, LH, and FSH were significantly improved after treatment in both dosage groups. In the group with a baseline serum testosterone level lower than 300 ng/dl, the average testosterone level increased from 265 to 637 ng/dl (p⬍0.001) in the 25-mg dose group and from 239 to 653 ng/dl (p⬍0.001) in the 50-mg dose group. In the group with a baseline serum testosterone level higher than 300 ng/dl, the average testosterone level increased from 482 to 867 ng/dl (p⬍0.001) in the 25-mg group, and from 475 to 867 ng/dl (p⬍0.001) in the 50-mg group). Three patients who reported depression at baseline experienced improvement in that condition after clomiphene citrate therapy. Adverse effects included male pattern alopecia (5 cases in 50-mg group, 1 case in 25-mg group) and gynecomastia (1 case in 50-mg group). These adverse effects disappeared after stopping treatment. Four patients in the 50-mg dose group developed minor elevations of GOT, GPT, but treatment was successfully continued. CONCLUSIONS: Clomiphene citrate therapy significantly improved serum testosterone level, which suggests that it may be effective for the treatment of LOH. Source of Funding: None
Change in Change Testosterone in PSA
1381
213.9⫾231.2 0.30⫾0.67
THE CHARACTERISTICS AND PREDICTIVE FACTORS OF NONRESPONDER TO TESTOSTERONE REPLACEMENT THERAPY IN TESTOSTERONE DEFICIENCY SYNDROME
N⫽40, P⬍0.0001
N⫽40, P⫽0.007
192.1⫾212.8 0.29⫾0.90 N⫽100, P⬍0.0001
Source of Funding: Auxilium Pharmaceuticals, Inc.
N⫽100, P⫽0.002
Min Gu Park, Mi Mi Oh, Dong Soo Lee, Jeong Wu Yu, Jae Hyun Bae, Seoul, Korea, Republic of; Yong Woo Kim, Suwon, Korea, Republic of; Je Jong Kim, Du Geon Moon*, Seoul, Korea, Republic of INTRODUCTION AND OBJECTIVES: To analyze characteristics of nonresponder to testosterone replacement therapy (TRT) and find out the predictive factors of nonresponder. METHODS: From 2006 to 2008, a total of 200 TDS patients who had been treated over 30 weeks with testosterone undecanoate (TU, Nebido®) were enrolled. Non-response to TRT (Gr I, n⫽47) was defined as the patients who answered as ⬘no symptom improvement⬘ at 30 weeks after TRT and the others were defined as the response group