Prostate Adenocarcinoma: TransCutaneous Hormones [PATCH] A Randomized-Controlled Trial of Transcutaneous Oestrogen Patches Versus LHRH Analogues in Prostate Cancer
- Compare the cardiovascular system-related morbidity and mortality in patients with
locally advanced or metastatic prostate cancer treated with transcutaneous estrogen
patches vs luteinizing hormone-releasing hormone analogues.
- Compare the activity of these treatments, in terms of castrate level of hormones,
failure-free survival, and biochemical failure, in these patients.
- Compare other toxicities, including osteoporosis, hot flushes, gynecomastia, and
anemia, in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1
of 2 treatment arms at 1(control):2 (patch) ratio.
- Arm I (control): Patients receive luteinizing hormone-releasing hormone analogues as
per local practice in the absence of unacceptable toxicity.
- Arm II (patch): Patients receive 3 transcutaneous estrogen patches, changing twice
weekly for 4 weeks. Patients' testosterone levels are measured at week 4. Patients
whose testosterone level is > 1.7 nmol/L continue to receive patch as before and have
their testosterone level measured every 2 weeks. Patients whose testosterone level is <
1.7 nmol/L at week 4 or any other point receive 2 transcutaneous estrogen patches
changed twice weekly in the absence of unacceptable toxicity.
Quality of life is assessed at baseline; at weeks 4, 8, and 12; every 3 months for 20
months; and then every 6 months thereafter.
After completion of study treatment, patients are followed periodically.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.
Allocation: Randomized, Primary Purpose: Treatment
Cardiovascular morbidity and mortality
Paul D. Abel
Charing Cross Hospital