Trials / Terminated
TerminatedNCT03869762
Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases.
A Phase II Study of Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- Cancer Trials Ireland · Network
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Open-label phase II multi-centre single arm study of Denosumab in combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer.
Detailed description
This is an open-label phase II multi-centre single arm study of Denosumab in combination with enzalutamide in progressive metastatic castrate-resistant prostate cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xgeva | Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing the RANKL/RANK interaction from occurring and resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer induced bone destruction. |
| DRUG | Xtandi | Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway. Enzalutamide competitively inhibits binding of androgens to androgen receptors, inhibits nuclear translocation of activated receptors and inhibits the association of the activated androgen receptor with DNA even in the setting of androgen receptor overexpression and in prostate cancer cells resistant to anti-androgens. Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression. |
Timeline
- Start date
- 2019-01-09
- Primary completion
- 2019-01-12
- Completion
- 2019-01-12
- First posted
- 2019-03-11
- Last updated
- 2026-04-13
Locations
7 sites across 1 country: Ireland
Source: ClinicalTrials.gov record NCT03869762. Inclusion in this directory is not an endorsement.