Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505278
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-23
Brief Title:
The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Impact of Circadian Rhythm-Based Medication Timing Adjustment on the Efficacy and Safety of Novel Hormonal Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the impact of medication timing adjustment on the effect of novel hormonal therapy NHT agents in patients with metastatic hormone-sensitive prostate cancer mHSPC The half of the patients will receive NHT agents in the morning and the other half will receive NHT agents in the evening
Detailed Description:
Metastatic hormone-sensitive prostate cancer mHSPC can be treated with androgen deprivation therapy ADT plus novel hormonal therapy NHT agents such as abiraterone enzalutamide and apalutamide However after a period of treatment patients inevitably develop resistance to hormonal therapy progressing to metastatic castration-resistant prostate cancer mCRPC Once resistance occurs treatment options are limited and the prognosis is poor Therefore enhancing the efficacy of hormonal therapy and delaying the onset of resistance is currently a focal point of research in advanced prostate cancer
Androgens are a fundamental basis for the growth proliferation and metastasis of prostate cancer cells exhibiting significant circadian rhythms in their synthesis and secretion The synthesis of androgens and their products such as androstenedione A4 and testosterone T accelerates in the early morning peaks around 800 AM then declines reaching a nadir around 800 PM NHT agents such as abiraterone primarily inhibit the synthesis of androgens by blocking the CYP17A1 enzyme thereby aiming to suppress tumor growth However abiraterone is currently administered mainly on an empty stomach in the morning when androgen and its metabolites have already peaked and been released into the bloodstream Hence inhibiting androgen synthesis at this time may not yield optimal effects
Chronotherapy refers to the administration of therapy in alignment with the circadian rhythms of the patient tumor and drug to enhance therapeutic efficacy and reduce adverse reactions In certain malignancies research has been conducted to adjust the timing of drug administration based on these circadian characteristics resulting in improved efficacy and reduced adverse reactions compared to traditional dosing schedules
However no study has explored the impact of different timing of NHT agents administration on the therapeutic efficacy and safety currently
Androgens are a fundamental basis for the growth proliferation and metastasis of prostate cancer cells exhibiting significant circadian rhythms in their synthesis and secretion The synthesis of androgens and their products such as androstenedione A4 and testosterone T accelerates in the early morning peaks around 800 AM then declines reaching a nadir around 800 PM NHT agents such as abiraterone primarily inhibit the synthesis of androgens by blocking the CYP17A1 enzyme thereby aiming to suppress tumor growth However abiraterone is currently administered mainly on an empty stomach in the morning when androgen and its metabolites have already peaked and been released into the bloodstream Hence inhibiting androgen synthesis at this time may not yield optimal effects
Chronotherapy refers to the administration of therapy in alignment with the circadian rhythms of the patient tumor and drug to enhance therapeutic efficacy and reduce adverse reactions In certain malignancies research has been conducted to adjust the timing of drug administration based on these circadian characteristics resulting in improved efficacy and reduced adverse reactions compared to traditional dosing schedules
However no study has explored the impact of different timing of NHT agents administration on the therapeutic efficacy and safety currently
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None