A1 Journal article (refereed)
Transdermal oestradiol and exercise in androgendeprivation therapy (ESTRACISE) : protocol (2024)


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., & Seikkula, H. (2024). Transdermal oestradiol and exercise in androgendeprivation therapy (ESTRACISE) : protocol. BJU International, Early View. https://doi.org/10.1111/bju.16361


JYU authors or editors


Publication details

All authors or editors: Jussila, Ilkka; Ahtiainen, Juha P.; Laakkonen, Eija K.; Siltari, Aino; Kaipia, Antti; Jokela, Tiina; Kärkkäinen, Minta; Newton, Rob; Raastad, Truls; Huhtala, Heini; et al.

Journal or series: BJU International

ISSN: 1464-4096

eISSN: 1464-410X

Publication year: 2024

Publication date: 08/04/2024

Volume: Early View

Publisher: Wiley-Blackwell

Publication country: United Kingdom

Publication language: English

DOI: https://doi.org/10.1111/bju.16361

Publication open access: Openly available

Publication channel open access: Partially open access channel

Publication is parallel published (JYX): https://jyx.jyu.fi/handle/123456789/94519


Abstract

Objective
To report the protocol of a study evaluating the efficacy of transdermal oestradiol (E2) gel in reducing the adverse effects of androgen deprivation therapy (ADT), specifically on sexual function, and to assess the utility of E2 in combination with supervised exercise.

Study Design and Methods
The primary endpoint of this open-label Phase IIA randomized controlled trial is the efficacy of transdermal E2 gel. Secondary endpoints include: (i) the occurrence of ADT-induced adverse effects; (ii) the safety and tolerability of E2; (iii) the impact of E2 with or without exercise on physical, physiological, muscle, and systemic biomarkers; and (iv) quality of life. The trial will recruit high-risk PCa patients (n = 310) undergoing external beam radiation therapy with adjuvant subcutaneous ADT. Participants will be stratified and randomized in a 1:1 ratio to either the E2 + ADT arm or the ADT-only control arm. Additionally, a subset of patients (n = 120) will be randomized into a supervised exercise programme.

Results
The primary outcome is assessed according to the efficacy of E2 in mitigating the deterioration of Expanded Prostate Cancer Index Composite sexual function domain scores. Secondary outcomes are assessed according to the occurrence of ADT-induced adverse effects, safety and tolerability of E2, impact of E2 with or without exercise on physical performance, body composition, bone mineral density, muscle size, systematic biomarkers, and quality of life.

Conclusion
The ESTRACISE study's innovative design can offer novel insights about the benefits of E2 gel, and the substudy can reinforce the benefits resistance training and deliver valuable new novel insights into the synergistic benefits of E2 gel and exercise, which are currently unknown.


Keywords: prostate cancer; cancer treatments; hormonal effects; physical functioning; hormone therapy; exercise (people); strength training

Free keywords: prostate cancer; androgen deprivation therapy; transdermal oestradiol; exercise; resistance training


Contributing organizations


Ministry reporting: Yes

Preliminary JUFO rating: 2


Last updated on 2024-26-04 at 13:58