Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-21
First Post:
2023-11-20
Brief Title:
Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy
Sponsor:
Central Finland Hospital District
Organization:
Central Finland Hospital District
Study Overview
Official Title:
Transdermal Estradiol and Exercise in Mitigating Adverse Effects of Androgen Deprivation Therapy for Prostate Cancer Radiation Therapy A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTRACISE
Brief 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 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 n310 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 n120 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
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 n310 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 n120 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 n310 will be done in a 11 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 n95 per arm The stratified randomization of the substudy participants in the training group or the non-training control group will be done in a 11 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 06 mgml 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 n60 and non-training control groups n60 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 n310 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 08 a Type 1 error probability of 005 and with dropout rate of 10
Stratified randomization n310 will be done in a 11 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 n95 per arm The stratified randomization of the substudy participants in the training group or the non-training control group will be done in a 11 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 06 mgml 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 n60 and non-training control groups n60 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 n310 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 08 a Type 1 error probability of 005 and with dropout rate of 10
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None