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Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial

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

Record History

  1. Completion pushed from Dec 31, 2033 to Dec 31, 2038v28
  2. Study sites revised (602)v27 See this version in full on ClinicalTrials.gov ↗
  3. Site details revised at 1 of 602 sitesv26
  4. Study sites revised (602)v25 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (602)v24 See this version in full on ClinicalTrials.gov ↗
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites: 601 to 602v23
  2. Trial status: Recruiting to Active, Not Recruiting Study sites: 599 to 601v22 Show 1 more changeShow less
    • Study sites: 599 to 601
  3. Study sites: 591 to 599v21
  4. Study sites: 579 to 591v20
  5. Start date: Dec 15, 2020 to Jan 21, 2021 Primary endpoints: 1 to 4 · Enrollment target: 2478 to 2753 · Study sites: 570 to 579 · 4 morev19 Show 7 more changesShow less
    • Primary endpoints: 1 to 4
    • Enrollment target: 2478 to 2753
    • Study sites: 570 to 579
    • Interventions: Apalutamide (Drug), Bicalutamide (Drug), Buserelin (Drug), Degarelix (Drug), Flutamide (Drug), Goserelin (Drug), Histrelin (Drug)… to Apalutamide (Drug), Bicalutamide (Drug), Biospecimen Collection (Procedure), Bone Scan (Procedure), Buserelin (Drug), Computed Tomography…
    • Secondary endpoints: 8 to 10
    • Study description expanded, about 47 words
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  6. Study sites: 552 to 570v18
  7. Study sites: 486 to 552v17
  8. Study sites: 436 to 486v16
  9. Study sites: 421 to 436v15
  10. Study sites: 405 to 421v14
  11. Study sites: 357 to 405v13
  12. Study sites: 289 to 357v12
  13. Eligibility criteria expanded, about 46 words Study description shortened, about 29 wordsv11 Show 1 more changeShow less
    • Study description shortened, about 29 words

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 250 to 289v10
  15. Study sites: 173 to 250v9
  16. Study sites: 121 to 173v8
  17. Trial status: Suspended to Recruiting Study sites: 103 to 121 · Completion date: Dec 31, 2038 to Dec 31, 2033 · Interventions: Abiraterone Acetate (Drug), Apalutamide (Drug), Bicalutamide (Drug), Buserelin (Drug), Degarelix (Drug), Flutamide (Drug), Goserelin… to Apalutamide (Drug), Bicalutamide (Drug), Buserelin (Drug), Degarelix (Drug), Flutamide (Drug), Goserelin (Drug), Histrelin (Drug)… · 4 morev7 Show 7 more changesShow less
    • Study sites: 103 to 121
    • Completion date: Dec 31, 2038 to Dec 31, 2033
    • Interventions: Abiraterone Acetate (Drug), Apalutamide (Drug), Bicalutamide (Drug), Buserelin (Drug), Degarelix (Drug), Flutamide (Drug), Goserelin… to Apalutamide (Drug), Bicalutamide (Drug), Buserelin (Drug), Degarelix (Drug), Flutamide (Drug), Goserelin (Drug), Histrelin (Drug)…
    • Eligibility criteria shortened, about 43 words
    • Secondary endpoints: 7 to 8
    • Primary endpoint revised
    • Study description expanded, about 355 words

    See this version in full on ClinicalTrials.gov ↗

  18. Trial status: Recruiting to Suspended Sponsor's reason: Design change Study sites: 83 to 103v6 Show 1 more changeShow less
    • Study sites: 83 to 103
  19. Study sites: 30 to 83v5
  20. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 30v4 Show 1 more changeShow less
    • Study sites: 0 to 30
  21. Start date: Nov 5, 2020 to Dec 15, 2020v3
  22. Secondary endpoints: 8 to 7v2 See this version in full on ClinicalTrials.gov ↗
  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 compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.
Trial Details
NCT Number NCT04513717
Lead Sponsor NRG Oncology
Collaborators: National Cancer Institute (NCI)
Conditions Prostate Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
Enrollment 2,753 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov