Phase 2 Prostate Cancer Trial, Recruiting NCT03522064 Sponsor: St Vincent's Hospital, Sydney Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT03522064
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:

  • You are male and have been diagnosed with prostate cancer (specifically a type called adenocarcinoma, confirmed by a tissue test)
  • Your cancer has a specific type of DNA repair fault called a "homologous recombination defect" (HRD), confirmed by a validated genetic test on tumour or blood samples
  • You are 18 years of age or older
  • You are generally well enough to carry out daily activities with little or no limitation (confirm with trial site)
  • Your PSA (a prostate cancer marker in your blood) has been rising on at least two tests taken at least one week apart, and is at least 2 on the scale used, despite having very low testosterone levels
  • Your testosterone level is very low (due to hormone treatment or surgical removal of the testicles at least one year ago)
  • At least 4 weeks have passed since your last cancer treatment, radiotherapy, or surgery (not counting hormone injections)
  • Your blood counts (platelets, white blood cells, and haemoglobin) are at healthy enough levels
  • Your liver is working well enough, based on blood tests
  • Your kidneys are working well enough, based on blood tests
  • Your heart has been assessed by a heart specialist and is working well enough
  • You have a stored tissue sample available, or you are willing to have a new biopsy taken
  • You are willing and able to follow all the requirements of the study
  • You have read and signed a consent form agreeing to take part

Who may not be able to join:

  • You have a medical reason that prevents you from taking the trial medication
  • You have pain from prostate cancer that requires strong (opioid) painkillers
  • Your cancer has spread to areas where a temporary increase in tumour activity (which the treatment may cause) could be dangerous — for example, bone spread that risks fracture, or cancer pressing on the spine or blocking the urinary system (confirm with trial site)
  • You have previously been treated with platinum-based chemotherapy or a type of drug called a PARP inhibitor (though a small group of up to 8 people with prior use of these treatments may still be considered)
  • Your life expectancy is estimated to be less than 3 months
  • Your cancer has spread to the brain or the lining around the brain and spinal cord
  • You have had a blood clot in the past and are not currently taking blood-thinning medication
  • You have had a heart attack or serious chest pain (unstable angina) within the last 2 years
  • Your red blood cell concentration is too high, or you have untreated severe sleep apnoea, or your heart failure is not well controlled
  • You have had another cancer within the last 5 years (some exceptions apply, such as certain skin cancers or non-invasive cancers that were fully treated, or if you have been completely cancer-free for at least 5 years)
  • You have another serious illness, including a severe infection, that could make it unsafe to take part
  • There are personal, family, social, or location-related factors that might prevent you from following the study schedule — including alcohol or drug dependency

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 5 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: Anthony M Joshua, MBBS, PhD, FRACP, St Vincent's Hospital

Phone: +61293555611

Australian sites

Kinghorn Cancer Centre, St. Vincent's Hospital, Sydney, New South Wales
0293555611

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
Sponsor
St Vincent's Hospital, Sydney
Registry
ClinicalTrials.gov
Start date
30 July 2018
Est. completion
30 September 2026

Where this trial is recruiting

🇦🇺 Australia

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

Primary endpoints

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: 5 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