Clinical trial · Interventional
Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
A Randomized, Controlled, Double-blind, Single Center，Clinical Trial to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Proxalutamide Combined With Androgen Deprivation Therapy（ADT）for High Risk Prostate Cancer
NCT05076851CI-TRIAL-00054431unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Proxalutamide combined with androgen deprivation therapy（ADT）for High risk prostate cancer ，This trial is A randomized, controlled, double-blind, single center.Treatment cycle is 6 months,
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoadjuvant Therapy \High Risk Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| placebo | Other | — | UNRESOLVED |
| Proxalutamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- placebo group
- description
- placebo+ADT
- interventionNames
- Other: placebo
- type
- EXPERIMENTAL
- label
- Proxalutamide
- description
- Proxalutamide +ADT
- interventionNames
- Drug: Proxalutamide
Primary outcomes (2)
- measure
- Pathologic Complete Response Rate
- timeFrame
- up to 6months
- description
- The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study 2. Patients must be ≥ 18，male 3. Histopathological by Prostate biopsy confirmed prostatic cancer（No Neuroendocrine prostate cancer or small cell carcinoma） 4. High-risk prostate cancer (T2c≤ clinical stage ≤T4 or Gleason score ≥8 or PSA≥20ng/ml) 5. Patients willing to undergo laparoscopic radical resection of prostate cancer and extensive lymph node dissection 6. ECOG PS：0-1 Exclusion Criteria: 1. Imaging or biopsy confirmed distant Metastatic lesion 2. The number of regional lymph nodes metastasis \>3 3. Patients had undergone The treatment of Systemic chemotherapy and endocrine therapy for prostate cancer 4. Patients had undergone prostate surgery、radical radiotherapy or Bilateral orchidectomy
References
Publications (0)
Data not yet available
No reference posted for this study.