Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy

StatusActive, Not Recruiting
PhasePhase 2
Started

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Record History

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  1. Study completion pushed from Mar 30, 2026 to Mar 30, 2028
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description revised
  2. 3 versions Re-verified since Jul 18, 2025, no change to tracked fieldsv25-v27
  3. Results first posted: Jul 3, 2025
    • Primary endpoint revised
    • Enrollment target: 50 to 45
    • Secondary endpoints: details revised at 3 of 3 entries
    v24
  4. Primary endpoint revised
    • Primary completion date changed from estimate of Mar 30, 2026 to Oct 3, 2024
    • Secondary endpoints: 5 to 3
    v23
  5. Primary and study completion dates: Mar 30, 2025 to Mar 30, 2026v22
Show 20 earlier versionsHide 20 earlier versions
  1. Re-verified, no change to tracked fieldsv21
  2. Primary and study completion dates: Jul 30, 2024 to Mar 30, 2025v20
  3. 5 versions Re-verified since Apr 5, 2023, no change to tracked fieldsv15-v19
  4. Primary and study completion dates: Feb 28, 2023 to Jul 30, 2024v14
  5. 3 versions Re-verified since Feb 23, 2022, no change to tracked fieldsv11-v13
  6. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 45 to confirmed 50
    • Site details revised
    v10
  7. Study completion date: Feb 28, 2024 to Feb 28, 2023
    • Study description revised
    • Study title revised
    v9
  8. 2 versions Re-verified since May 16, 2019, no change to tracked fieldsv7-v8
  9. Primary completion date: Mar 2023 to Feb 28, 2023v6 Show 7 more changesShow less
    • Study completion date: Mar 2023 to Feb 28, 2024
    • Interventions: Apalutamide (Drug), Prostatectomy (Procedure), Questionnaires (Behavioral) to Apalutamide (Drug), Quality-of-Life Assessment (Other), Radical Prostatectomy (Procedure)
    • Study description expanded, about 166 words
    • Study site revised
    • Collaborator revised
    • Eligibility criteria expanded, about 2 words
    • Study title shortened, about 1 word
  10. Re-verified, no change to tracked fieldsv5
  11. Study completion date: Mar 2024 to Mar 2023
    • Eligibility criteria expanded, about 58 words
    • Study description shortened, about 829 words
    • Site contact updated
    v4
  12. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Apr 2023 to Mar 2023
    • Study completion date: Apr 2024 to Mar 2024
    • Start date changed from estimate of Apr 2018 to Mar 22, 2018
    • Site details revised
  13. Start date: Feb 2018 to Apr 2018
    • Primary completion date: Feb 2023 to Apr 2023
    • Study completion date: Feb 2024 to Apr 2024
    v2
  1. Study First Submitted
  • 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.
This phase II trial studies how well apalutamide works in treating patients with prostate cancer before radical prostatectomy. Androgen can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by lowering the amount of androgen the body makes and may make it less likely for patients to receive radiation therapy after surgery.
Trial Details
NCT Number NCT03412396
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Prostate Adenocarcinoma, Stage IIB Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov