Prostate CancerPhase 2ESTRACISENCT06271551
Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy
A Phase 2 study testing Transdermal estrogen, Active Comparator: Androgen deprivation therapy and Resistance training in people with Prostate Cancer, run by Central Finland Hospital District.
Trial summary
The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients. The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Transdermal estrogen, Active Comparator: Androgen deprivation therapy and Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with localized prostate cancer, and scheduled for external beam radiation with adjuvant subcutaneous androgen deprivation therapy, leuprorelin (LHRH agonist) for at least 12 months without any other endocrinology treatments for prostate cancer
- Adults (age over 18 years)
- Sufficient performance status (Eastern Cooperative Oncology Group, 0-1)
- Body mass index between 18.5 - 30.0
- Willingness to participate and signed consent
Who cannot join
- Patients with low-risk prostate cancer (ISUP Gleason grade 1)
- Patients with expected adjuvant androgen deprivation therapy for less than one year
- Distant bone, lymph node, or soft tissue metastasis
- Cardiac pacemaker
- Prior recent cardiovascular event or stroke (<12 months)
- Past or current venous thromboembolism
Show all 12Show fewer
- Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)
- Concurrent glucocorticoid treatment
- Physical disabilities for regular exercise
- Any medication or condition considered as a contraindication to estradiol (allergy to adjuvant compounds (carbomer, trolamine), history with thromboembolic disorders (protein C, protein S, or antithrombin deficiency), porphyria, acute or previous liver disease, drugs with cytochrome P450 enzyme metabolism (anticonvulsants: phenobarbital, phenytoin, carbamazepine; anti-infectives: rifampicin, rifapentine, nevirapine, efavirenz; and St. John's wort)) or leuprorelin (allergy to adjuvant compounds (polylactic acid), Qt-time prolonging drugs (quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, methadone, moxifloxacin, antipsychotics)
- Known allergy to estradiol or leuprorelin
- Expected poor compliance or expected survival time of less than one year
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy: A Randomized Controlled Trial
The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients.
The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects.
Read more
Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training.
Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups.
Read the detailed description
The current study is an open-label study examining a drug with known tolerability and safety profile (phase IIA trial). The study will recruit 310 prostate cancer patients with high-risk disease and scheduled for external beam radiation with adjuvant subcutaneous androgen deprivation therapy, leuprorelin (LHRH agonist).
Stratified randomization (n=310) will be done in a 1:1 fashion to the transdermal estradiol + androgen deprivation therapy arm or control arm (androgen deprivation therapy only). Stratified randomization will be based on two covariates, which are sexual dysfunction score and BMI. The use of the stratified randomization method will guarantee even distribution of covariates, which could likely affect the study outcomes. Additionally, a total of 120 participants who are willing to participate in the supervised resistance training program and have sufficient performance status (ECOG 0-1) will be randomized to the resistance training group or the non-training control group. A total of 30 men from each arm will be recruited to supervised training and 30 men from each arm the non-training control group. Participants of the ESTRACISE who do not participate in the exercise substudy will form a non-training group (n=95 per arm). The stratified randomization of the substudy participants in the training group or the non-training control group will be done in a 1:1 fashion before the start of the training period. Stratified randomization will be based on two main covariates, which are age and the self-reported physical activity level of the participant.
ESTRACISE participants allocated to the transdermal estradiol arm will use transdermal estradiol gel (E2) as a dose of 750 ug (EstroGel 0.6 mg/ml) in addition to androgen deprivation therapy for 12 months. Additionally, substudy participants allocated to the resistance training groups will be attending supervised group resistance training sessions twice a week for six months. The resistance training will start after six months of androgen deprivation therapy. Participants in the non-training groups are advised to stay physically active but they will do it at their own discretion.
According to the standard treatment protocol, all participants will receive androgen deprivation therapy as leuprorelin, subcutaneous injections at three months intervals for a minimum of one year, and standard external beam radiation for prostate cancer with standard clinical dosing and fractionation at the discretion of the radiation oncologist.
The research methodologies include questionnaires (expanded prostate cancer index composition 26, world health organization quality of life brief version, and patient health questionnaire), adverse event screening, medication compliance screening, computerized tomography (CT) of the thigh muscle, bioimpedance analysis (BIA), 3D-imaging of the body composition, body composition and bone mineral assessment by dual-energy x-ray absorptiometry (DXA), strength, functional capacity, physical activity measurements, and serum and plasma blood samples. In addition, muscle biopsies are collected from a subset of participants allocated in the resistance training (n=60) and non-training control groups (n=60). The primary measurement timepoints are baseline (0 months), after six months of androgen deprivation therapy, and after twelve months of androgen deprivation therapy.
Based on prior sample size estimation of primary outcome the n=310 should be more than adequate to detect statistically significant differences in the mean sexual domain score between the two study arms. The true difference in the mean is expected to be 10, with a probability (power) of 0.8, a Type 1 error probability of 0.05, and with dropout rate of 10%.
- Conditions
- Prostate Cancer
- Being tested
- Transdermal estrogen, Active Comparator: Androgen deprivation therapy, Resistance training
- Keywords
- Prostate cancer, Androgen deprivation therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal estrogenDrug
Participants (n=155) receiving transdermal estradiol for 12 months.
Active Comparator: Androgen deprivation therapyDrug
Participants (n=155) receiving solely androgen deprivation therapy for 12 months.
Resistance trainingBehavioural
Participants (n=30 in each arm) performing supervised resistance training for six months.
| Study group | Role | What they receive |
|---|---|---|
| Transdermal estradiol | Experimental | Participants (n=155) receiving transdermal estradiol and androgen deprivation therapy. Receives: Drug: Transdermal estrogen; Behavioral: Resistance training |
| Androgen deprivation therapy | Active comparator | Participants (n=155) receiving solely androgen deprivation therapy. Receives: Drug: Active Comparator: Androgen deprivation therapy; Behavioral: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy.
Compared between the two arms. Scores scaled from 0 - 100, higher score means better sexual function.
Measured: Twelve and six months.
Secondary outcomes (17)
The occurrence of androgen deprivation therapy induced adverse effects.
Compared between different groups. Assessed by CTCAE (Common Termionology Criteria for Adverse Events). Number of participants with androgen deprivation therapy related adverse events, and grading of adverse event from 1 - 5. Higher grading indicates worse adverse event.
Measured: Twelve and six months.
Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events).
Transdermal estradiol arm. Number and grading of adverse events from 1 - 5. Higher grading means worse adverse event.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer.
Compared between different groups. One repetition maximum tests and maximal hand grip strength assessed as kilograms or newtons. Higher kilograms or newtons indicates higher strength.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ).
Compared between different groups. From CMJ flight time is defined as milliseconds. Higher flight time in milliseconds represents higher jump height and explosive strength.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on 6-minute walk (functional capacity).
Compared between different groups. Walking distance and heart rate will be collected from 6-minute walk test. Higher walking distance with lower heart rate indicates better functional capacity.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on loaded 10-stair climb test (functional capacity).
Compared between different groups. Time taken to ascend and descend from 10-stair climb test. Less time taken to complete 10-stair climb test indicates better functional capacity.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on body composition.
Compared between different groups. More lean mass, and less fat mass indicates better body composition.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on bone mineral density.
Compared between different groups. Higher bone mineral density indicates better outcome.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh muscle mass.
Compared between different groups. Higher mid-thigh muscles cross-sectional area indicates higher mid-thigh muscle mass.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh fat mass.
Compared between different groups. Lower adipose tissue size indicates less mid-thigh fat mass.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on hormone (testosterone and estradiol) levels, and cancer (PSA) status.
Compared between different groups. Higher or lower hormones levels could indicate better outcome, depending on the arm of the participant, and overall status. Lower PSA concentration usually indicates better outcome.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on concentration of PVK, IL-6, TNF-α, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, and triglycerides).
Compared between different groups. Higher or lower concentration of biomarkers can indicate better outcome, depending on the exact biomarker.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on type I and II myofibers' cross-sectional area, myonuclei, myonuclear domain, the satellite cell count, androgen receptor and myostatin content
Compared between different groups. Higher type I and II myofibers' cross-sectional area indicates improved skeletal muscle characteristics. Higher myonuclei, myonuclear domain, satellitte cell count, and androgen and myostatin content usually indicates improved cellular function.
Measured: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on muscle cellular function (e.g., HSP70, alpha B-crystallin, HSP60, cytochrome c oxidase subunit IV proteins)
Compared between different groups. Higher or lower concentration of proteins could indicate improved or worsen muscle cellular function, depending on the exact protein.
Measured: Twelve and six months.
Number of participants with resistance training induced adverse events.
Compared between different groups. Assessed by CTCAE (Common Termionology Criteria for Adverse Events). Number of participants with androgen deprivation therapy related adverse events, and grading of adverse event from 1 - 5. Higher grading indicates worse adverse event.
Measured: Twelve and six months.
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF).
Compared between different groups. Subdomain scores scaled from 0 to 100. Higher overall and subdomain score in WHOQOL-BREF indicates higher quality of life.
Measured: Twelve and six months.
The Patient Health Questionnaire score (PHQ-9) overall and subdomain score.
Compared between different groups. Scores scaled from 0 to 27. Higher overall score in PHQ-9 indicates more depressive symptoms.
Measured: Twelve and six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 fashion to receive transdermal estradiol and androgen deprivation or solely androgen deprivation therapy. In addition subgroup of participants are randomized in a 1:1 fashion to perform resistance training or to be allocated in non-training control group.
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Finland Hospital District
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, University of Jyvaskyla, Tampere University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271551
- Sponsor's protocol ID
- ESTRACISE
- Acronym
- ESTRACISE
- Status last verified
- Feb 2024
- First submitted
- 20 Nov 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jussila I, Ahtiainen JP, Laakkonen EK, Siltari A, Kaipia A, Jokela T, Karkkainen M, Newton R, Raastad T, Huhtala H, Murtola TJ, Seikkula H. Transdermal oestradiol and exercise in androgen deprivation therapy (ESTRACISE): protocol. BJU Int. 2024 Jul;134(1):110-118. doi: 10.1111/bju.16361. Epub 2024 Apr 8.
PubMed 38587276
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06271551
- Acronym / sponsor ID
- ESTRACISE / ESTRACISE
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Androgen deprivation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- Central Finland Hospital DistrictUniversity, hospital or other
- Collaborators
- Tampere University, University of Jyvaskyla, Tampere University Hospital
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the clinical trial is to find out whether transdermal estradiol will reduce the adverse effects of androgen deprivation therapy in prostate cancer patients.
The primary aim of this study is to estimate the efficacy of transdermal estradiol (E2) in reducing androgen deprivation therapy induced adverse effects on sexual function. A secondary aim of this study is to estimate the utility of E2 and the combination of E2 with supervised exercise in reducing other androgen deprivation therapy related adverse effects.
Participants (n=310) will use transdermal estradiol for 12 months concomitant to androgen deprivation therapy. The use of transdermal estradiol will start at the beginning of the trial, at the same time as androgen deprivation therapy. A subgroup of participants (n=120) will also be allocated to perform six months supervised resistance training.
Researchers will compare transdermal estradiol group to control group, and resistance training groups and non-training control groups.
Detailed description
The current study is an open-label study examining a drug with known tolerability and safety profile (phase IIA trial). The study will recruit 310 prostate cancer patients with high-risk disease and scheduled for external beam radiation with adjuvant subcutaneous androgen deprivation therapy, leuprorelin (LHRH agonist).
Stratified randomization (n=310) will be done in a 1:1 fashion to the transdermal estradiol + androgen deprivation therapy arm or control arm (androgen deprivation therapy only). Stratified randomization will be based on two covariates, which are sexual dysfunction score and BMI. The use of the stratified randomization method will guarantee even distribution of covariates, which could likely affect the study outcomes. Additionally, a total of 120 participants who are willing to participate in the supervised resistance training program and have sufficient performance status (ECOG 0-1) will be randomized to the resistance training group or the non-training control group. A total of 30 men from each arm will be recruited to supervised training and 30 men from each arm the non-training control group. Participants of the ESTRACISE who do not participate in the exercise substudy will form a non-training group (n=95 per arm). The stratified randomization of the substudy participants in the training group or the non-training control group will be done in a 1:1 fashion before the start of the training period. Stratified randomization will be based on two main covariates, which are age and the self-reported physical activity level of the participant.
ESTRACISE participants allocated to the transdermal estradiol arm will use transdermal estradiol gel (E2) as a dose of 750 ug (EstroGel 0.6 mg/ml) in addition to androgen deprivation therapy for 12 months. Additionally, substudy participants allocated to the resistance training groups will be attending supervised group resistance training sessions twice a week for six months. The resistance training will start after six months of androgen deprivation therapy. Participants in the non-training groups are advised to stay physically active but they will do it at their own discretion.
According to the standard treatment protocol, all participants will receive androgen deprivation therapy as leuprorelin, subcutaneous injections at three months intervals for a minimum of one year, and standard external beam radiation for prostate cancer with standard clinical dosing and fractionation at the discretion of the radiation oncologist.
The research methodologies include questionnaires (expanded prostate cancer index composition 26, world health organization quality of life brief version, and patient health questionnaire), adverse event screening, medication compliance screening, computerized tomography (CT) of the thigh muscle, bioimpedance analysis (BIA), 3D-imaging of the body composition, body composition and bone mineral assessment by dual-energy x-ray absorptiometry (DXA), strength, functional capacity, physical activity measurements, and serum and plasma blood samples. In addition, muscle biopsies are collected from a subset of participants allocated in the resistance training (n=60) and non-training control groups (n=60). The primary measurement timepoints are baseline (0 months), after six months of androgen deprivation therapy, and after twelve months of androgen deprivation therapy.
Based on prior sample size estimation of primary outcome the n=310 should be more than adequate to detect statistically significant differences in the mean sexual domain score between the two study arms. The true difference in the mean is expected to be 10, with a probability (power) of 0.8, a Type 1 error probability of 0.05, and with dropout rate of 10%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 fashion to receive transdermal estradiol and androgen deprivation or solely androgen deprivation therapy. In addition subgroup of participants are randomized in a 1:1 fashion to perform resistance training or to be allocated in non-training control group.
| Arm | Type | Receives |
|---|---|---|
| Transdermal estradiol | Experimental | Drug: Transdermal estrogen, Behavioral: Resistance trainingParticipants (n=155) receiving transdermal estradiol and androgen deprivation therapy. |
| Androgen deprivation therapy | Active comparator | Drug: Active Comparator: Androgen deprivation therapy, Behavioral: Resistance trainingParticipants (n=155) receiving solely androgen deprivation therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men with localized prostate cancer, and scheduled for external beam radiation with adjuvant subcutaneous androgen deprivation therapy, leuprorelin (LHRH agonist) for at least 12 months without any other endocrinology treatments for prostate cancer
- Adults (age over 18 years)
- Sufficient performance status (Eastern Cooperative Oncology Group, 0-1)
- Body mass index between 18.5 - 30.0
- Willingness to participate and signed consent
Key exclusion criteria (12 listed)
- Patients with low-risk prostate cancer (ISUP Gleason grade 1)
- Patients with expected adjuvant androgen deprivation therapy for less than one year
- Distant bone, lymph node, or soft tissue metastasis
- Cardiac pacemaker
- Prior recent cardiovascular event or stroke (<12 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal estrogenParticipants (n=155) receiving transdermal estradiol for 12 months. | Drug | Transdermal estradiol |
| Active Comparator: Androgen deprivation therapyParticipants (n=155) receiving solely androgen deprivation therapy for 12 months. | Drug | Androgen deprivation therapy |
| Resistance trainingParticipants (n=30 in each arm) performing supervised resistance training for six months. | Behavioural | Androgen deprivation therapy, Transdermal estradiol |
Primary outcome
The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy.
Time frame: Twelve and six months.
Compared between the two arms. Scores scaled from 0 - 100, higher score means better sexual function.
17 secondary outcomes
The occurrence of androgen deprivation therapy induced adverse effects.
Time frame: Twelve and six months.
Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events).
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer.
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ).
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on 6-minute walk (functional capacity).
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on loaded 10-stair climb test (functional capacity).
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on body composition.
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on bone mineral density.
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh muscle mass.
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh fat mass.
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on hormone (testosterone and estradiol) levels, and cancer (PSA) status.
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on concentration of PVK, IL-6, TNF-α, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, and triglycerides).
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on type I and II myofibers' cross-sectional area, myonuclei, myonuclear domain, the satellite cell count, androgen receptor and myostatin content
Time frame: Twelve and six months.
Impact of transdermal estradiol with or without 6-month supervised resistance training on muscle cellular function (e.g., HSP70, alpha B-crystallin, HSP60, cytochrome c oxidase subunit IV proteins)
Time frame: Twelve and six months.
Number of participants with resistance training induced adverse events.
Time frame: Twelve and six months.
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF).
Time frame: Twelve and six months.
The Patient Health Questionnaire score (PHQ-9) overall and subdomain score.
Time frame: Twelve and six months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 38587276Jussila I, Ahtiainen JP, Laakkonen EK, Siltari A, Kaipia A, Jokela T, Karkkainen M, Newton R, Raastad T, Huhtala H, Murtola TJ, Seikkula H. Transdermal oestradiol and exercise in androgen deprivation therapy (ESTRACISE): protocol. BJU Int. 2024 Jul;134(1):110-118. doi: 10.1111/bju.16361. Epub 2024 Apr 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transdermal estrogen, Active Comparator: Androgen deprivation therapy and Resistance training in people with Prostate Cancer, run by Central Finland Hospital District.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heikki Seikkula, MD, Docent (+358142691299, heikki.seikkula@hyvaks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy. (time frame: Twelve and six months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06271551, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.