TY - JOUR
T1 - Early hormonal data from a multicentre phase II trial using transdermal oestrogen patches as first-line hormonal therapy in patients with locally advanced or metastatic prostate cancer
AU - Langley, RE
AU - Godsland, IF
AU - Kynaston, H
AU - Clarke, NW
AU - Rosen, SD
AU - Morgan, RC
AU - Pollock, P
AU - Kockelbergh, R
AU - Lalani, El-Nasir
AU - Dearnaley, D
AU - Parmar, M
AU - Abel, PD
PY - 2008/8/1
Y1 - 2008/8/1
N2 - OBJECTIVE
To assess the hormonal effects of Fem7 (R) (Merck, KGaA, Darmstadt, Germany) 100 mu g transdermal oestrogen patches on men undergoing first-line androgen-deprivation therapy for prostate cancer.
PATIENTS AND METHODS
PATCH is a multicentre, randomized, phase II trial for men with locally advanced or metastatic prostate cancer, comparing luteinizing hormone-releasing hormone agonist therapy with oestrogen patches. To assess the dosing schedule for the patches. as this was the first time that this brand of patch had been used in men, and to reassure patients and participating clinicians, the Independent Data Monitoring Committee agreed to early release of hormonal data from this study.
RESULTS
Oestradiol, testosterone and prostate-specific antigen (PSA) levels are presented for the first group of 14 patients who received the patches (with I withdrawal) and for whom there were >= 12 weeks of follow-up by March 2007. After 12 weeks, testosterone levels (nmol/L) in eight of the 13 patients were 1.7, two were 1.7-2 and three were >2. The median (range) serum oestradiol levels was 442 (52.1-1542) pmol/L and all patients had a PSA response, with eight having a PSA level of
AB - OBJECTIVE
To assess the hormonal effects of Fem7 (R) (Merck, KGaA, Darmstadt, Germany) 100 mu g transdermal oestrogen patches on men undergoing first-line androgen-deprivation therapy for prostate cancer.
PATIENTS AND METHODS
PATCH is a multicentre, randomized, phase II trial for men with locally advanced or metastatic prostate cancer, comparing luteinizing hormone-releasing hormone agonist therapy with oestrogen patches. To assess the dosing schedule for the patches. as this was the first time that this brand of patch had been used in men, and to reassure patients and participating clinicians, the Independent Data Monitoring Committee agreed to early release of hormonal data from this study.
RESULTS
Oestradiol, testosterone and prostate-specific antigen (PSA) levels are presented for the first group of 14 patients who received the patches (with I withdrawal) and for whom there were >= 12 weeks of follow-up by March 2007. After 12 weeks, testosterone levels (nmol/L) in eight of the 13 patients were 1.7, two were 1.7-2 and three were >2. The median (range) serum oestradiol levels was 442 (52.1-1542) pmol/L and all patients had a PSA response, with eight having a PSA level of
KW - hormone therapy
KW - randomized controlled trial
KW - prostate cancer
KW - transdermal oestrogen patches
U2 - 10.1111/j.1464-410X.2008.07583.x
DO - 10.1111/j.1464-410X.2008.07583.x
M3 - Article
C2 - 18422771
SN - 1464-410X
VL - 102
SP - 442
EP - 445
JO - BJU international
JF - BJU international
IS - 4
ER -