Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study

StatusTerminated
PhasePhase 2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial terminated Sponsor's reason: The trial was ended sooner than expected due to a combination of factors, including slow accrual, lower than anticipated benefit to patients, and loss of funding from the study sponsor. Show 6 more changesShow less
    • Results posted: Oct 19, 2026
    • Study completion date changed from estimate of Apr 14, 2027 to Apr 14, 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints revised (6)
    • Primary endpoint revised
    • Site details revised
  2. Study completion pushed from Apr 7, 2026 to Apr 14, 2027v17
  3. Trial status: Recruiting to Active, Not Recruitingv16 Show 4 more changesShow less
    • Enrollment target: estimated 34 to confirmed 8
    • Primary completion date changed from estimate of Mar 31, 2027 to Jul 29, 2025
    • Study completion date: Dec 31, 2027 to Apr 7, 2026
    • Site details revised
  4. Eligibility criteria shortened, about 369 words
    • Secondary endpoints: details revised at 2 of 6 entries
    v15
  5. Re-verified, no change to tracked fieldsv14
Show 12 earlier versionsHide 12 earlier versions
  1. Interventions: Apalutamide (Drug), Biopsy (Procedure), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Golimumab (Drug), Magnetic… to Apalutamide (Drug), Biopsy (Procedure), Biospecimen Collection (Procedure), Bone Scan (Procedure), Computed Tomography (Procedure)…
    • Eligibility criteria expanded, about 27 words
    • Site contact updated
    • Study description shortened, about 5 words
    v13
  2. Re-verified, no change to tracked fieldsv12
  3. Start date: May 6, 2024 to May 23, 2024v11
  4. Start date changed from estimate of Jun 3, 2024 to May 6, 2024v10
  5. Start date: May 4, 2024 to Jun 3, 2024v9
  6. Start date: Apr 4, 2024 to May 4, 2024v8
  7. Start date: Feb 29, 2024 to Apr 4, 2024v7
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 9, 2024 to Feb 29, 2024
    • Site details revised
    v6
  9. Start date: Jan 7, 2024 to Feb 9, 2024
    • Eligibility criteria shortened, about 15 words
    v5
  10. Start date: Dec 8, 2023 to Jan 7, 2024v4
  11. Start date: Dec 1, 2023 to Dec 8, 2023v3
  12. 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.
This phase II trial tests how well golimumab and apalutamide work in treating patients with castration resistant prostate cancer. Golimumab is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells. Giving golimumab and apalutamide may work better in treating patients with castration-resistant prostate cancer.
Trial Details
NCT Number NCT05960578
Lead Sponsor University of Washington
Collaborators: Janssen Scientific Affairs, LLC
Conditions
(from sponsor)		 Metastatic Castration-Resistant Prostate Carcinoma, Prostate Adenocarcinoma, Stage IV Prostate Cancer AJCC v8
Related terms Prostatic Neoplasms
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov