Clinical trial · Interventional
An Evaluation of the Efficacy and Safety of Apalutamide as Neoadjuvant Endocrine Therapy in High-Risk and Oligometastatic Prostate Cancer
NCT04997252CI-TRIAL-00075143unknownN/AClinicalTrials.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)
The neoadjuvant therapy with apalutamide can significantly improve the prognosis of patients with high-risk and oligometastatic prostate cancer, lower the rate of positive margins, reduce recurrence, and show high safety.
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 |
|---|---|---|---|
| High-Risk and Oligometastatic Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apalutamide | Drug | Apalutamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- high-risk and oligometastatic prostate cance
- description
- Neoadjuvant therapy with apalutamide in combination with luteinizing hormone-releasing hormone analogues
- interventionNames
- Drug: Apalutamide
Primary outcomes (1)
- measure
- rPFS
- timeFrame
- Change from Baseline at preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
- description
- radiographic progression-free survival
Secondary outcomes (6)
- measure
- pCR
- timeFrame
- preoperative 1, 2, and 3 months and postoperative 1, 3, 6, 9, 12, 18, and 24 months.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult males aged above 18 years old, no healthy volunteers included; 2. Prostate cancer confirmed by pathological findings; 3. High risk based on risk assessment, or laboratory tests suggestive of oligometastasis; 4. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy; 5. ECOG score of 0 - 1 6. Agreement to undergo preoperative and postoperative endocrine therapy; 7. Voluntary signing of an ICF for the clinical trial Exclusion Criteria: 1. Any other tumor disease requiring treatment; 2. Any organ metastasis confirmed by imaging, such as liver and brain metastases, or the possibility of paralysis due to spinal cord metastasis; 3. A history of epilepsy or any condition that may lead to seizures; 4. Severe liver or kidney dysfunction, severe cardiovascular or cerebrovascular diseases, and systemic immune system diseases.
References
Publications (0)
Data not yet available
No reference posted for this study.