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

Abstract

OBJECTIVE To assess the hormonal effects of Fem7® (Merck, KGaA, Darmstadt, Germany) 100 µg 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 1 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 <4 ng/mL. CONCLUSION These results confirm that oestrogen patches produce castrate levels of testosterone and concomitant PSA responses. They also highlighted the potential differences between different brands of oestrogen patches, and the need to monitor hormonal response, toxicity and efficacy until more experience with oestrogen patches for this clinical indication is obtained. The number of patches recommended in the PATCH study has now been increased.

Luteinizing Hormone–Releasing Hormone Agonists: A Quick Reference for Prevalence Rates of Potential Adverse Effects

“…13,14 An alternative hormonal induction of androgen deprivation involves either an oral estrogen, such as diethylstilbestrol 15 or a parenteral estrogen, such as transdermal estradiol. [16][17][18][19] High-dose estrogens can shut down the hypothalamic-pituitary-gonadal axis. 12 Historically, the use of oral estrogens as a treatment for PCa was abandoned because of thromboembolic complications.…”

Diethylstilboestrol for the treatment of prostate cancer: past, present and future

“…In addition, bone mineral densities of the lumbar spine and the hip were maintained or significantly increased, leading to improved World Health Organization (WHO) osteoporotic risk classification. Recently published early results of a multicentre phase II trial comparing LHRH agonist therapy with oestrogen patches in men with locally advanced or metastatic prostate cancer confirmed that oestrogen patches produce castrate levels of testosterone and concomitant PSA responses [57]. All of the initial 14 patients included in the study had a decrease in PSA level (>70% by 12 weeks) and nine of them had a PSA level of less than 4 ng/ml.…”

Quality of life issues in men undergoing androgen deprivation therapy: a review

“…54 If incontinence (climacturia) occurs with orgasm, this can even be more distressing for both partners and is underreported by patients. 55 96 Figure 1 Features of body feminisation. Figure 2 Sexual changes on androgen deprivation therapy.…”