Phase 2 Prostate Cancer Trial, Recruiting NCT06353386 Sponsor: Merck Sharp & Dohme LLC Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT06353386
Recruiting Phase 2 🇦🇺 Australian site

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:

  • People who have a confirmed diagnosis of prostate adenocarcinoma (a specific type of prostate cancer), not including a type called small cell.
  • People whose prostate cancer has gotten worse, and who have had hormone-suppressing treatment (ADT) or surgical removal of the testicles within the 6 months before screening.
  • People whose cancer has shown signs of progressing after stopping certain older anti-hormone medications (with specific waiting periods depending on which medication was used — confirm timing with trial site).
  • People who have evidence that the cancer has spread to other parts of the body (metastatic disease).
  • People who have previously been treated with 1 or 2 newer hormone-blocking medications for prostate cancer (at any stage), and whose cancer has continued to grow during or after that treatment.
  • People taking bone-strengthening medications (such as bisphosphonates or denosumab) who have been on a stable dose for more than 4 weeks before joining the trial.
  • People who had side effects from previous cancer treatments must have largely recovered before joining.
  • People living with HIV, provided the HIV is well controlled on treatment.
  • People who have Hepatitis B must have been on antiviral treatment for at least 4 weeks and have an undetectable level of the virus in their blood.
  • People with a history of Hepatitis C infection, provided the virus is no longer detectable in their blood.

Who may not be able to join:

  • People with a history of problems with the pituitary gland.
  • People with poorly controlled diabetes.
  • People with serious or unstable heart or blood vessel conditions, including recent stroke, mini-stroke, or heart attack within 6 months, severe heart failure, symptomatic coronary heart disease, or unstable chest pain.
  • People with a personal or family history of a heart rhythm condition involving a prolonged QT interval (an electrical problem in the heart).
  • People with certain blood or bone marrow disorders (MDS or AML), or signs suggesting these conditions.
  • People with a history of, or current, adrenal gland insufficiency (where the adrenal glands don't produce enough hormones).
  • People who have had lung inflammation (not caused by infection) that required steroid treatment, or who currently have lung inflammation.
  • People living with HIV who have also had Kaposi's sarcoma or a condition called Multicentric Castleman's Disease.
  • People who have had major surgery (including certain prostate procedures, but not prostate biopsy) within 28 days before joining, and have not yet fully recovered.
  • People on an unstable dose of thyroid hormone medication within 6 months before the first dose.
  • People who received a whole blood transfusion within the 120 days before joining (certain other blood product transfusions may be acceptable — confirm with trial site).
  • People who have received other systemic cancer treatments or experimental therapies within 4 weeks before joining.
  • People who have received radiotherapy within 2 weeks of starting the trial, or who still have side effects from radiation requiring steroid treatment.
  • People who have received a live or weakened-live vaccine within 30 days before the first dose (non-live vaccines are generally acceptable).
  • People with a known immune system deficiency, or who have been taking steroid or immune-suppressing medications within 7 days before the first dose.
  • People who have or have had another cancer (besides prostate cancer) that is still active or required treatment within the past 3 years.
  • People with active cancer spread to the brain or spinal fluid.
  • People with an active autoimmune disease that has needed systemic treatment within the past 2 years.
  • People with an active infection that requires systemic treatment.
  • People with active, ongoing Hepatitis B or Hepatitis C infection.

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

Principal Investigator: Medical Director, Merck Sharp & Dohme LLC

Phone: 1-888-577-8839

Australian sites

Macquarie University-MQ Health Clinical Trials Unit ( Site 0108), Macquarie University, New South Wales
+61402856430
Gallipoli Medical Research Ltd-GMRF CTU ( Site 0107), Greenslopes, Queensland
+61 7 33947284
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0110), Melbourne, Victoria
+61385595000

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 May 2024
Est. completion
15 January 2029

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇱 Chile 🇨🇴 Colombia 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇳🇿 New Zealand 🇵🇱 Poland 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

3 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Number of participants who experience one or more dose-limiting toxicities (DLTs); Number of participants who experience one or more adverse events (AEs); Number of participants who discontinue study intervention due to an AE; Prostate-specific antigen (PSA) response rate

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