Transdermal estradiol and exercise in mitigating adverse effects of androgen deprivation therapy for prostate cancer radiation therapy (ESTRACISE): Randomized controlled trial
EUCT number: 2023-504704-28-00
ClinicalTrials.gov Identifier: NCT06271551

Table of contents
Project description
Androgen deprivation therapy is a commonly employed treatment for tumor suppression in high-risk prostate cancer patients. However, despite its efficacy in tumor suppression, it is associated with significant adverse effects that profoundly impact patients' quality of life. The adverse effects include sexual dysfunction, diminished male secondary sexual characteristics, impotence, hot flashes, osteopenia, muscle loss and weakness, and negative changes in body composition. These adverse effects arise from the depletion of estradiol and the suppression of testosterone, both of which are consequences of androgen deprivation therapy.
To date, no medical intervention has been employed in clinical practice, that could combat these adverse effects. However, new existing phase I and II studies have shown promising results in mitigating some of the adverse effects by employing non-oral estradiol medication. As such the main goal of ESTRACISE is to determine the effectiveness of transdermal estradiol in mitigating the adverse effects of androgen deprivation therapy, and finding novel benefits of estradiol. The secondary goal is to define the multidimensional benefits of resistance training in mitigating the adverse effects, and whether estradiol combined with resistance training would have superior benefits.
Data includes:
- Questionnaires (EPIC-26, WHQOL-BREF, and PHQ-9)
- Imaging methods (computerized tomography of the thigh, body composition, and bone mineral density assessment by dual-energy X-ray absorptiometry)
- Physical performance (strength and functional capacity)
- Blood samples (testosterone, estradiol, prostate-specific antigen, PVK, IL-6, TNF-α, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, triglycerides, and variety of RNA sequencing)
- Muscle biopsies of vastus lateralis muscle (skeletal muscle characteristics, and cellular and molecular function)
- Other (adverse event screening, medication compliance, concomitant medications)
Publications:
Jussila, I., Ahtiainen, J.P., Laakkonen, E.K., Siltari, A., Kaipia, A., Jokela, T., Kärkkäinen, M., Newton, R., Raastad, T., Huhtala, H., Murtola, T.J. and Seikkula, H. (2024), Transdermal oestradiol and exercise in androgen deprivation therapy (ESTRACISE): protocol. BJU Int.