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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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Nov 1, 2026 to Nov 1, 2031v31
  2. Trial status changed: Recruiting → Active, Not Recruiting Trial sites expanded: 347 → 350 locationsv30 Show 1 more changeShow less
    • Trial sites expanded: 347 → 350 locations
  3. Site details revised at 2 of 347 sitesv29
  4. Study sites: 344 to 347v28
  5. Study sites: 338 to 344v27
Show 25 earlier versionsHide 25 earlier versions
  1. Study sites revised (338)v26 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 335 to 338v25
  3. Start date: Mar 5, 2020 to Apr 16, 2020 Study sites: 319 to 335 · Interventions: Apalutamide (Drug), Hormone Therapy (Drug), Quality-of-Life Assessment (Other), Questionnaire Administration (Other), Radiation Therapy… to Apalutamide (Drug), Biospecimen Collection (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Hormone Therapy (Drug)… · Eligibility criteria shortened, about 20 words · 2 morev24 Show 5 more changesShow less
    • Study sites: 319 to 335
    • Interventions: Apalutamide (Drug), Hormone Therapy (Drug), Quality-of-Life Assessment (Other), Questionnaire Administration (Other), Radiation Therapy… to Apalutamide (Drug), Biospecimen Collection (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure), Hormone Therapy (Drug)…
    • Eligibility criteria shortened, about 20 words
    • Study description expanded, about 39 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 314 to 319v23
  5. Study sites: 293 to 314v22
  6. Re-verified, no change to tracked fieldsv21
  7. Study sites: 285 to 293v20
  8. Study sites: 280 to 285v19
  9. Study sites: 278 to 280v18
  10. Study sites: 269 to 278v17
  11. Study sites: 245 to 269v16
  12. Eligibility criteria expanded, about 3 wordsv15 See this version in full on ClinicalTrials.gov ↗
  13. Study sites: 243 to 245v14
  14. Study sites: 213 to 243v13
  15. Study sites: 192 to 213v12
  16. Study sites: 191 to 192 Completion date: Nov 1, 2031 to Nov 1, 2026 · Interventions: Abiraterone Acetate (Drug), Apalutamide (Drug), Hormone Therapy (Drug), Prednisone (Drug), Quality-of-Life Assessment (Other)… to Apalutamide (Drug), Hormone Therapy (Drug), Quality-of-Life Assessment (Other), Questionnaire Administration (Other), Radiation Therapy… · Eligibility criteria expanded, about 63 words · 3 morev11 Show 6 more changesShow less
    • Completion date: Nov 1, 2031 to Nov 1, 2026
    • Interventions: Abiraterone Acetate (Drug), Apalutamide (Drug), Hormone Therapy (Drug), Prednisone (Drug), Quality-of-Life Assessment (Other)… to Apalutamide (Drug), Hormone Therapy (Drug), Quality-of-Life Assessment (Other), Questionnaire Administration (Other), Radiation Therapy…
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints revised (7)
    • Study description shortened, about 47 words
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  17. Trial status: Suspended to Recruiting Study sites: 186 to 191v10 Show 1 more changeShow less
    • Study sites: 186 to 191
  18. Trial status: Recruiting to Suspended Sponsor's reason: Design change Site details revised at 186 of 186 sitesv9 Show 1 more changeShow less
    • Site details revised at 186 of 186 sites
  19. Study sites: 180 to 186v8
  20. Study sites: 141 to 180v7
  21. Study sites: 101 to 141v6
  22. Study sites: 51 to 101v5
  23. Study sites: 4 to 51v4
  24. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date changed from estimate of Mar 19, 2020 to Mar 5, 2020v3 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date changed from estimate of Mar 19, 2020 to Mar 5, 2020
  25. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
NRG Oncology
67 trials monitored
See 5 trials at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
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.
Trial Details
NCT Number NCT04134260
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
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
Enrollment 586 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov