Trial · NCT06575257
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
NCT06575257, Phase 2, Recruiting, Xijing Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer. Trials, record NCT06575257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06575257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
- NCT number
- NCT06575257
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 80 participants, estimated
- Lead sponsor
- Xijing Hospital
- Conditions
- Prostate Cancer
- Interventions
- Darolutamide, Goserelin 3.6 mg
- First posted
- 2024-08-28
- Last updated
- 2024-08-28
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Complete Response Rate | After 12 weeks of neoadjuvant therapy + RP + PLND | The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy |
| Primary | Proportion of Subjects With Minimal Residual Disease | After 12 weeks of neoadjuvant therapy + RP + PLND | The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy |
| Secondary | Rate of Stage Degradation | After 12 weeks of neoadjuvant therapy + RP + PLND | Clinical or pathological stage degradation after neoadjuvant therapy |
| Secondary | Rate of Positive Surgical Margins | After 12 weeks of neoadjuvant therapy + RP + PLND | The proportion of subjects with positive surgical margins after radical prostatectomy |
| Secondary | Rate of Complete Serum Remission | After 12 weeks of neoadjuvant therapy | The proportion of subjects whose PSA is less than or equal to 0.2 ng/ml after 3 months of treatment |
| Secondary | Proportion of subjects without PSA progression | 2 years after RP | The proportion of subjects whose PSA has never gone below 1 ng/ml or who receive any radiotherapy or systemic treatment after radical prostatectomy |
| Secondary | Imaging Response Rate | After 12 weeks of neoadjuvant therapy | The proportion of subjects whose primary tumor is in complete remission on imaging or residual tumor's maximum diameter is less than 0.5cm |
| Secondary | Recovery time of urinary continence (day) | 1 years after RP | The recovery time of urinary continence (day) after radical prostatectomy, defined as 0 pad/day. |
| Secondary | biochemical recurrence-free survival (bRFS) | 3 years after RP | biochemical recurrence-free survival (bRFS) defined as time to PSA ≥ 0.2 ng/ml after radical prostatectomy. |
| Secondary | metastasis-free survival (MFS) | 5 years after RP | time from date of randomization to date of evidence of systemic disease on bone scan or cross-sectional imaging. |
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.
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/NCT06575257
GET https://conductscience.org/api/trials/v1/NCT06575257/registered