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Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Study sites: 342 to 341v36
  2. Re-verified, no change to tracked fieldsv35
  3. Trial sites expanded: 303 → 342 locationsv34
  4. 9 versions Re-verified since Aug 15, 2025, no change to tracked fieldsv25-v33
  5. Study sites: 302 to 303v24
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites: 301 to 302v23
  2. Study sites: 299 to 301v22
  3. Site details revised at 2 of 299 sitesv21
  4. Study sites: 293 to 299v20
  5. Re-verified, no change to tracked fieldsv19
  6. Study sites: 292 to 293v18
  7. Study sites revised (292)v17
  8. Site contacts updated at 2 of 292 sitesv16
  9. Study sites: 286 to 292v15
  10. Site details revised at 1 of 286 sitesv14
  11. Study sites: 239 to 286v13
  12. Primary endpoints: 3 to 4v12 Show 7 more changesShow less
    • Study sites: 209 to 239
    • Start date: Jul 19, 2021 to Oct 8, 2020
    • Interventions: 3-Dimensional Conformal Radiation Therapy (Radiation), Apalutamide (Drug), Computed Tomography (Procedure), External Beam Radiation Therapy… to 3-Dimensional Conformal Radiation Therapy (Radiation), Apalutamide (Drug), Computed Tomography (Procedure), Degarelix (Drug), External Beam…
    • Eligibility criteria expanded, about 163 words
    • Secondary endpoints: 8 to 12
    • Study description expanded, about 368 words
    • Study title expanded, about 1 word
  13. Study sites: 86 to 209v11
  14. Start date: Oct 8, 2020 to Jul 19, 2021v10
  15. Primary and study completion dates: Dec 31, 2027 to Dec 31, 2032v9
  16. Study sites: 40 to 86v8
  17. Study sites: 36 to 40v7
  18. Study sites: 2 to 36v6
  19. Re-verified, no change to tracked fieldsv5
  20. Study sites: 1 to 2v4
  21. Re-verified, no change to tracked fieldsv3
  22. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase III trial tests two questions by two separate comparisons of therapies. The first question is whether enhanced therapy (apalutamide in combination with abiraterone + prednisone) added to standard of care (prostate radiation therapy and short term androgen deprivation) is more effective compared to standard of care alone in patients with prostate cancer who experience biochemical recurrence (a rise in the blood level of prostate specific antigen \[PSA\] after surgical removal of the prostate cancer). A second question tests treatment in patients with biochemical recurrence who show prostate cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET) imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced therapy (apalutamide in combination with abiraterone + prednisone) is tested. Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the pelvis. Androgens are hormones that may cause the growth of prostate cancer cells. Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor cells and shrink tumors that have spread. This trial may help doctors determine if using PET results to deliver more tailored treatment (i.e., adding apalutamide, with or without targeted radiation therapy, to standard of care treatment) works better than standard of care treatment alone in patients with biochemical recurrence of prostate cancer.
Trial Details
NCT Number NCT04423211
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Biochemically Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma, Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 804 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov