Trial · NCT06505278
The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy
NCT06505278, Phase 2, Unknown, Sun Yat-sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy. Trials, record NCT06505278. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06505278
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy
- NCT number
- NCT06505278
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 70 participants, estimated
- Lead sponsor
- Sun Yat-sen University
- Conditions
- Prostate Cancer
- Interventions
- Receive Abiraterone plus prednisone/Enzalutamide/Apalutamide/Rezvilutamide in the evening
- First posted
- 2024-07-17
- Last updated
- 2024-08-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PSA response rate defiend as the proportion of participants whose prostate specific antigen (PSA) decreases by more than 90% from baseline after three months of treatment | Baseline and Week 12 | PSA is a critical indicator for assessing the efficacy of prostate cancer treatment; typically, a lower PSA value suggests better therapeutic outcomes. A second PSA measurement is confirmed after 3 weeks from week 12. |
| Secondary | Circulating tumor cell (CTC) clearance rate defiend as the proportion testing negative for circulating tumor cell (CTC) at week 12 in patients with a baseline CTC count of ≥1 | Baseline and Week 12 | CTC are tumor cells that enter the bloodstream and are associated with the metastasis of tumors. Typically, a lower CTC count is indicative of better therapeutic efficacy. |
| Secondary | Clinical benefit rate (CBR) defiend as the proportion of patients comfirming partial response (PR), complete response (CR), or stable disease (SD). | Through study completion, an average of 18 months | Clinical benefit refers to participants achieving PR, CR, or SD. |
| Secondary | Objective response rate (ORR) defiend as the proportion of participants confirming partial response (PR) or complete response (CR) | Through study completion, an average of 18 months | Objective response refers to participants achieving PR or CR, which would be confirmed 4 weeks later. |
| Secondary | Duration of relief defiend from the first assessment of complete response (CR) or partial response (PR) until the detection of disease progression (PD) | From CR or PR to PD, up to 18 months | Duration of relief represents the length of time the tumor remains reduced under this treatment regimen. |
| Secondary | Time to achieve objective relief defiend from randomization until achieving complete response (CR) or partial response (PR). | From start of treatment to CR or PR, up to 18 months | Time to achieve objective relief is an important indicator of therapeutic efficacy. |
| Secondary | Time to PSA progression defiend the time from detection of PSA nadir to PSA progression | From start of treatment to PSA progression, up to 18 months | PSA progression refers to PSA\>1ng/ml, with at least a one-week interval between PSA measurement and two consecutive increases of\>50% compared to the baseline value. |
| Secondary | Radiographic progression-free survival (rPFS) defiend from randomization until radiographic progression according to RECIST 1.1 criteria | From start of treatment to radiographic progression, up to 18 months | rPFS refers to the time from randomization to radiographic progression defined as tumor progression assessed by CT, MRI, or ECT according to RECIST 1.1 criteria, which is an important indicator for treatment efficacy. |
| Secondary | Overall survival defined from randomization until death from any cause. | From start of treatment to death from any cause, up to 18 months | Time to death refers to the time from randomization to death from any cause, which is a crucial indicator for treatment efficacy. |
| Secondary | Treatment emerged adverse event (TEAE) | Throughout the entire study period，an average of 18 months | Treatment emerged adverse event would be assessed by NCI-CTCAE 5.0. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06505278
GET https://conductscience.org/api/trials/v1/NCT06505278/registered