Trial · NCT06060587
Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone
NCT06060587, Phase 2, Withdrawn, Northwestern University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone. Trials, record NCT06060587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06060587
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Phase II Study of ADT + Abiraterone vs ADT + Docetaxel + Abiraterone
- NCT number
- NCT06060587
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Prostate Cancer
- Interventions
- Docetaxel, ADT, Abiraterone
- First posted
- 2023-09-29
- Last updated
- 2025-10-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess Progression Free Survival (PFS) | Up to 1 year after completion of study treatment | Calculated the progression-free survival time as the time that elapses between the date of randomization and the day of first documented disease progression (per RECIST 1.1 or PCWG3) or death from any cause for all evaluable patients. PFS will be calculated based on the Kaplan-Meier estimates of PFS for each treatment arm (abiraterone+docetaxel+ADT compared to abiraterone+ADT). |
| Secondary | Assess Overall Survival (OS) | Up to 1 year after completion of study treatment | To assess the OS, this is defined as the time from date of randomization until time to death from any cause for all evaluable patients. OS will be calculated based on the Kaplan-Meier estimates of OS. |
| Secondary | Assess PSA Response Rate | 6 months (+/- 30 days) after randomization | The PSA level drawn 6 months (+/- 30 days) after randomization will be used to assess PSA response. |
| Secondary | Assessment of Time to castration resistant prostate cancer | Up to 1 year after completion of study treatment | This endpoint will calculate the time to the development of castration resistance from date of randomization to the time of PSA progression with serum testosterone level being at ≤ 50 ng/ml |
| Secondary | Assess time to compare for any difference in efficacy between arms | Up to 1 year after completion of study treatment | This endpoint will calculate the time to the initiation of the subsequent anti-neoplastic therapy for each treatment arm from the date of randomization to the date of initiation of the next (non-study) anti-neoplastic agent for prostate cancer. |
| Other | Assess Quality of Life (QoL) | Time between the initiation of trial therapy to 30 days from the last dose of study drug | FACT-P QoL assessment tool for each treatment arm (abiraterone+docetaxel+ADT and abiraterone+ADT) to compare for any difference in efficacy |
| Other | Assessment of Rates of Adverse Events (AEs)/Serious adverse events (SAEs) | Time between the initiation of trial therapy to 30 days from the last dose of study drug | To assess the rate of adverse events for each treatment arm. Safety will be measured as the frequency of AEs by type, severity (grade), timing and attribution to trial therapy (per NCI CTCAE v5.0). |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 |
Source NIH RePORTER
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/NCT06060587
GET https://conductscience.org/api/trials/v1/NCT06060587/registered