Clinical trial · Interventional
Efficacy and Safety of Apalutamide in Combination With 89Sr as Neoadjuvant Therapy in Prostate Cancer With ≤10 Bone Metastases
NCT05740488CI-TRIAL-00075074unknownN/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 aim of this study is to evaluate the efficacy and safety of apalutamide in combination with 89Sr as neoadjuvant therapy in prostate cancer with ≤10 bone metastases. The primary endpoint is PFS and the second endpoints are pCR, rPFS, PSA response, pain score, number and extent of bone metastases.
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 |
|---|---|---|---|
| Prostate Cancer With ≤10 Bone Metastases | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 89Sr | Drug | — | UNRESOLVED |
| Apalutamide | Drug | Apalutamide | ALIAS |
| Luteinizing Hormone-Releasing Hormone Analog | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- apalutamide combined with 89Sr and ADT
- description
- Neoadjuvant therapy with apalutamide in combination with 89Sr and ADT
- interventionNames
- Drug: Apalutamide
- Drug: 89Sr
- Drug: Luteinizing Hormone-Releasing Hormone Analog
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Up to 2 years after radical prostatectomy
- description
- progression-free survival
Secondary outcomes (5)
- measure
- pCR
- timeFrame
- Up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Prostate cancer confirmed by pathological findings; 2. Bone metastasis confirmed by bone scan, the number of bone metastases ≤10 3. Agreement to undergo laparoscopic radical prostatectomy + pelvic lymphadenectomy; 4. ECOG score of 0 - 1 5. Agreement to undergo preoperative and postoperative endocrine therapy and 89Sr radionuclide therapy; 6. 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.