Phase 2 Prostate Cancer Trial, Recruiting NCT06800313 Sponsor: Janssen Research & Development, LLC Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06800313
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

For all parts of the trial:

  • Men aged 18 or older
  • People whose prostate cancer has been confirmed by laboratory testing of tissue or cell samples
  • People whose blood counts, kidney function, and liver function are at adequate levels
  • People who are able to swallow tablets or capsules

For the advanced prostate cancer arms (mCRPC – certain phases):

  • People who have had their testicles surgically removed, or who are receiving ongoing hormone-blocking therapy, and have very low testosterone levels as a result
  • People whose prostate cancer has continued to worsen, shown by rising PSA levels, despite their most recent treatment

For the SOAR arm (Phase 2 Part 2A):

  • People with hormone-sensitive prostate cancer that has spread to distant parts of the body, confirmed by standard imaging
  • People with a PSA level of 0.2 ng/mL or higher, after receiving a specific type of hormone therapy (called an ARPI) for between 180 and 365 days
  • People who have not shown signs of cancer progression on imaging or through PSA levels while receiving that hormone therapy

For the hormone-sensitive advanced prostate cancer arms (Phase 2 Parts 2B, 2C, and 2D):

  • People with testosterone levels above 150 ng/mL
  • People with hormone-sensitive prostate cancer that has spread to distant parts of the body, confirmed by standard imaging, and a PSA level above 2.0 ng/mL

Who may not be able to join:

For all parts of the trial:

  • People who have had a recent serious bleeding event, or who have a known bleeding disorder
  • People whose cancer includes a specific tumour type called neuroendocrine or small cell carcinoma (confirmed by tissue testing)
  • People who are taking corticosteroid medication continuously at a dose above the equivalent of 10 mg per day of prednisone
  • People who have a significant ongoing or prior serious medical condition

For the advanced prostate cancer arms (mCRPC – certain phases):

  • People who have received systemic cancer treatments or experimental drugs within 2 weeks before starting the trial (some treatments may require an even longer gap before joining — confirm with trial site)

For the SOAR arm (Phase 2 Part 2A):

  • People who have previously received chemotherapy for prostate cancer

For the hormone-sensitive advanced prostate cancer arms (Phase 2 Parts 2B, 2C, and 2D):

  • People whose cancer has only spread to lymph nodes in the pelvic region, without more distant spread

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 844-434-4210

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
20 February 2025
Est. completion
1 April 2028

Where this trial is recruiting

🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Frequency of dose-limiting toxicities (DLTs); Frequency and severity of AEs and abnormal ECG, laboratory and clinical changes since baseline; Phase 1 Part 2 (formulation exploration) relative bioavailability

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov