madman
Super Moderator
TESTOSTERONE THERAPY IN MEN ON ACTIVE SURVEILLANCE FOR PROSTATE CANCER (2022)
Jose M. Flores, Carolyn A. Salter, Nicole Benfante, Lawrence Jenkins, Behfar Ehdaie, Vincent Laudone, James Eastham, and John P. Mulhall
Abstract
INTRODUCTION AND OBJECTIVE:
The role of testosterone therapy (TTH) in men with prostate cancer (PC) is debated, especially in men on active surveillance (AS). This study aimed to review our data on TTH in this population.
METHODS:
The study population consisted of (i) men with PC on active surveillance (ii) with two total T (TT) levels <300 ng/dL (iii) associated with symptoms (iii) performed using LCMS (v) conducted in an early morning fashion who (vi) pursued T therapy (TTH). TTH included exogenous (transdermal, intramuscular) and clomiphene citrate (CC) in the setting of low/low-normal LH levels. T lab work including PSA levels was checked within 4 weeks of TTH initiation, every three months in the first year, and every six months after that. Target TT level was the middle tertile of the normal reference range at our institution. We report on T and PSA levels in this group.
RESULTS:
82 patients are included. Mean age = 64 ± 9 years. Median pre-TTH PSA levels were 4.6 [3.4, 6.7] ng/mL. Mean baseline TT levels were 305 ± 145 ng/dL. 19% of these men had a TT level <200 ng/dL. Median Gleason score (GS) was 6 with 90% 3+3, 9% 3+4 and 1% 4+3. The median duration on AS before TTH was 14 [1, 43] months. 45% received transdermal T, 19% intramuscular T, and 36% CC. Post-TTH TT = 553 ± 268 ng/dL, PSA = 4.9 [3.2, 9.2] Median duration of TTH at last follow-up was 14 [1, 39] months. Median PSA change per patient was 0.3 [-0.9, 2.6] ng/mL, representing a median of 14 (-24, 70) % change in PSA per patient (p= 0.045). 42% had a decrease in PSA, 58% an increase. In 88% of men who experienced a rise in PSA, the PSA rose ≥10%. 50% of men on TTH who had a PSA level below 4 ng/dL rose above 4. 28% of men experienced a PSA level increase ≥1 ng/mL per year. In 18% of these men, TTH was stopped and definitive PC treatment was instituted. In men with ≤1 ng/mL per year increase in PSA, another 18% opted for definitive PC treatment. The most common reason for this was PSA anxiety.
CONCLUSIONS:
In men with PC on AS treated with TTH, minimal changes in PSA were seen, with equal numbers of men experiencing a rise and a drop in PSA. About a fifth of men ceased AS and proceeded to definitive therapy for their PC.
Jose M. Flores, Carolyn A. Salter, Nicole Benfante, Lawrence Jenkins, Behfar Ehdaie, Vincent Laudone, James Eastham, and John P. Mulhall
Abstract
INTRODUCTION AND OBJECTIVE:
The role of testosterone therapy (TTH) in men with prostate cancer (PC) is debated, especially in men on active surveillance (AS). This study aimed to review our data on TTH in this population.
METHODS:
The study population consisted of (i) men with PC on active surveillance (ii) with two total T (TT) levels <300 ng/dL (iii) associated with symptoms (iii) performed using LCMS (v) conducted in an early morning fashion who (vi) pursued T therapy (TTH). TTH included exogenous (transdermal, intramuscular) and clomiphene citrate (CC) in the setting of low/low-normal LH levels. T lab work including PSA levels was checked within 4 weeks of TTH initiation, every three months in the first year, and every six months after that. Target TT level was the middle tertile of the normal reference range at our institution. We report on T and PSA levels in this group.
RESULTS:
82 patients are included. Mean age = 64 ± 9 years. Median pre-TTH PSA levels were 4.6 [3.4, 6.7] ng/mL. Mean baseline TT levels were 305 ± 145 ng/dL. 19% of these men had a TT level <200 ng/dL. Median Gleason score (GS) was 6 with 90% 3+3, 9% 3+4 and 1% 4+3. The median duration on AS before TTH was 14 [1, 43] months. 45% received transdermal T, 19% intramuscular T, and 36% CC. Post-TTH TT = 553 ± 268 ng/dL, PSA = 4.9 [3.2, 9.2] Median duration of TTH at last follow-up was 14 [1, 39] months. Median PSA change per patient was 0.3 [-0.9, 2.6] ng/mL, representing a median of 14 (-24, 70) % change in PSA per patient (p= 0.045). 42% had a decrease in PSA, 58% an increase. In 88% of men who experienced a rise in PSA, the PSA rose ≥10%. 50% of men on TTH who had a PSA level below 4 ng/dL rose above 4. 28% of men experienced a PSA level increase ≥1 ng/mL per year. In 18% of these men, TTH was stopped and definitive PC treatment was instituted. In men with ≤1 ng/mL per year increase in PSA, another 18% opted for definitive PC treatment. The most common reason for this was PSA anxiety.
CONCLUSIONS:
In men with PC on AS treated with TTH, minimal changes in PSA were seen, with equal numbers of men experiencing a rise and a drop in PSA. About a fifth of men ceased AS and proceeded to definitive therapy for their PC.