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Transdermal estradiol and exercise in mitigating adverse effects of androgen deprivation therapy for prostate cancer radiation therapy (ESTRACISE)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-504704-28-00
Acronym
ESTRACISE
Enrollment
310
Registered
2023-08-21
Start date
2024-09-01
Completion date
Unknown
Last updated
2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Brief summary

Primary endpoint will be the efficacy of transdermal estradiol in mitigating the sexual symptoms of ADT

Detailed description

Occurrence of ADT-induced adverse effects during ADT in different study groups, Tolerability and safety of transdermal E2 during the one-year ADT adjuvant treatment period, Impact of transdermal E2 with or without 6-month resistance exercise on the muscle strength, functional capacity, body composition, lean-body muscle mass, and systematic biomarkers (g.e., blood biomarkers of and inflammatory health and muscle biomarkers), Safety and tolerability of 6-month physical exercise combined with or without transdermal E2 during ADT, Quality of life and perceived fatigue during ADT in different study groups

Interventions

DRUGEstrogel 0
DRUG6 mg/g -geeli
DRUGEstrogel® 0
DRUG6 mg/g-gel
DRUGdoseringspump
DRUGEnanton Depot Dual 11
DRUG25 mg injektiokuiva-aine ja liuotin suspensiota varten
DRUGesitäytetty ruisku
DRUGLEUPRORELIN
DRUGLeuprorelin Sandoz 5 mg implantaatti

Sponsors

Central Finland Hospital District Central Finland Hospital Nova
Lead SponsorOTHER

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Primary endpoint will be the efficacy of transdermal estradiol in mitigating the sexual symptoms of ADT

Secondary

MeasureTime frame
Occurrence of ADT-induced adverse effects during ADT in different study groups, Tolerability and safety of transdermal E2 during the one-year ADT adjuvant treatment period, Impact of transdermal E2 with or without 6-month resistance exercise on the muscle strength, functional capacity, body composition, lean-body muscle mass, and systematic biomarkers (g.e., blood biomarkers of and inflammatory health and muscle biomarkers), Safety and tolerability of 6-month physical exercise combined with or without transdermal E2 during ADT, Quality of life and perceived fatigue during ADT in different study groups

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 8, 2026