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Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial
This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.
Details
| Lead sponsor | NRG Oncology |
|---|---|
| Phase | PHASE3 |
| Status | RECRUITING |
| Enrolment | 586 |
| Start date | Thu Apr 16 2020 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sun Nov 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Prostate Adenocarcinoma
- Stage I Prostate Cancer AJCC v8
- Stage II Prostate Cancer AJCC v8
- Stage III Prostate Cancer AJCC v8
- Stage IVA Prostate Cancer AJCC v8
Interventions
- Apalutamide
- Biospecimen Collection
- Bone Scan
- Computed Tomography
- Hormone Therapy
- Magnetic Resonance Imaging
- Positron Emission Tomography
- Quality-of-Life Assessment
- Questionnaire Administration
- Radiation Therapy
Countries
Canada, United States