Phase 2 Prostate Cancer Trial, Recruiting NCT05393791 Sponsor: Leiden University Medical Center Condition: Prostate Cancer
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Phase 2 Prostate Cancer Trial, Recruiting

NCT05393791
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 are willing and able to give their informed consent to participate
  • People aged 18 or older
  • People who have been diagnosed with prostate adenocarcinoma (a specific type of prostate cancer), confirmed through a tissue or cell sample
  • People who are currently receiving hormone therapy to lower testosterone (either through medication or surgical removal of the testicles), with testosterone levels at or below a certain low level at the time of screening
  • People whose prostate cancer has spread to other parts of the body, confirmed by bone scan and/or CT scan
  • People whose cancer has continued to grow or spread despite hormone therapy, shown by rising PSA levels over time and/or new or worsening areas on scans
  • People with a PSA level of 2 ng/mL or higher
  • People with a general health status rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities with no more than moderate limitation) (confirm with trial site)
  • People whose cancer-related pain is stable and well-controlled, with no urgent need for radiation treatment
  • People with an estimated life expectancy of at least 12 months
  • People who have stored prostate cancer tissue available to share, or who are willing to have a new tumour biopsy taken
  • People whose blood counts, liver function, kidney function, and other organ measures fall within acceptable ranges as determined by blood tests (confirm with trial site)
  • People who have stopped any other prostate cancer treatments (except bone-protecting medications such as denosumab or bisphosphonates) at least 3 weeks before joining the trial
  • People who are able to swallow the trial medication and follow the trial requirements

Who may not be able to join:

  • People with a serious medical or psychiatric condition that the trial doctor believes could interfere with participation
  • People who have been diagnosed with or treated for another type of cancer (other than certain skin cancers, a specific type of bladder cancer, or carcinoma in situ that has been fully removed) within the past 2 years
  • People with known or suspected cancer that has spread to the brain or the lining around the brain or spinal cord
  • People whose prostate cancer has a specific cell type known as small-cell or neuroendocrine (confirm with trial site)
  • People who have had radiation treatment to the prostate tumour itself within 3 weeks before the screening visit
  • People who have had radiation or radioactive therapy to treat cancer spread (metastases) within 3 weeks before screening, unless it was given only to relieve pain
  • People with a history of uncontrolled seizures, if they and their doctor are considering a specific trial medication called enzalutamide
  • People with unstable heart conditions, including certain types of irregular heartbeat or significant heart failure
  • People with a known HIV infection, or active hepatitis B or C infection
  • People with a known gut or digestive condition that could affect how the trial medication is absorbed
  • People who have previously been treated with certain hormone-blocking medications, including abiraterone, apalutamide, darolutamide, enzalutamide, or ketoconazole (note: prior treatment with docetaxel for earlier-stage prostate cancer is allowed)
  • People with any other condition or situation that the trial doctor believes would make participation unsafe or unsuitable

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 15 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: Tom van der Hulle, MD, Leiden University Medical Center

Phone: 0031715263464

Australian sites

Border Medical Oncology Research Unit / The Border Cancer Hospital, Albury, New South Wales
Chris O'Brien Lifehouse, Camperdown, New South Wales
+61 2 8514 0194
St George Hospital, Kogarah, New South Wales
+61 2 9113 1111
Calvary Mater Newcastle, Newcastle, New South Wales
+612 40143282
Genesis Care North Shore, St Leonards, New South Wales
+61 474 164 541
Sydney Adventist Hospital, Wahroonga, New South Wales
+61 2 9480 6280
Sunshine Coast University Hospital, Birtinya, Queensland
+61752020651
Mater Hospital Brisbane, South Brisbane, Queensland
Royal Adelaide Hospital, Adelaide, South Australia
+6170742336
ICON Cancer Centre, Adelaide, South Australia
+61884740220
Eastern Health Box Hill, Box Hill, Victoria
+61390952465
Fiona Stanly Hospital, Murdoch, Western Australia
+61 8 6152 6530

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
Leiden University Medical Center
Registry
ClinicalTrials.gov
Start date
10 November 2022
Est. completion
10 November 2027

Where this trial is recruiting

🇦🇺 Australia 🇳🇱 Netherlands

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

Primary endpoints

Time to treatment failure

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: 15 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