Phase 2 Prostate Cancer Trial, Recruiting NCT05521412 Sponsor: Peter MacCallum Cancer Centre, Australia Condition: Prostate Cancer
Back to Prostate Cancer

Phase 2 Prostate Cancer Trial, Recruiting

NCT05521412
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:

  • The person has given written consent to participate in the trial.
  • The person is male and aged 18 or older at the time of signing consent.
  • The person has a confirmed diagnosis of prostate cancer (adenocarcinoma), or a clear diagnosis of prostate cancer that has spread to bones or lymph nodes, along with a raised PSA level in the blood.
  • The person has a general health and activity level rated at 0, 1, or 2 on a standard medical scale (meaning they are able to carry out some daily activities, even if limited — confirm with trial site).
  • The person has previously received at least one course of taxane chemotherapy (a specific type of cancer drug), unless their doctor determined it was medically unsuitable.
  • The person has previously been treated with at least one newer type of hormone-blocking drug for prostate cancer, such as enzalutamide, abiraterone, apalutamide, or darolutamide.
  • The cancer has shown signs of getting worse, based on rising PSA blood test results, growth of measurable tumours, or new spots appearing on a bone scan.
  • The person has either had surgical removal of the testicles or is currently receiving hormone-lowering injections to keep testosterone very low.
  • The person's testosterone level in the blood is at or below a very low threshold (≤ 1.75 nmol/L or ≤ 50 ng/dL).
  • A special type of scan (PSMA PET/CT) shows that the cancer strongly absorbs a PSMA-targeted tracer, meeting specific minimum uptake levels at sites of disease (confirm exact scan requirements with trial site).
  • The person is expected to live for at least 6 months.
  • The person has adequate blood counts, liver function, and kidney function, meeting specific minimum levels set by the trial (confirm exact required values with trial site).
  • Sexually active participants are willing to use an appropriate barrier method of contraception.
  • The person is willing and able to follow all trial requirements, including attending all assessments and completing all treatments.
  • At least 3 weeks have passed since any surgery or radiotherapy before joining the trial.

Who may not be able to join:

  • The person has previously been treated with any radioactive substance targeting cancer, such as PSMA-targeted radioligand therapy, radium-223, strontium-89, or samarium-153.
  • A PET scan shows areas of cancer that do not respond to the PSMA tracer but do show up on a different type of scan (FDG-PET), suggesting the cancer may not respond to this treatment.
  • The person has been diagnosed with another cancer (other than certain low-risk skin cancers) within the past 2 years that is likely to return within 24 months.
  • The person has cancer that has spread to the brain and is causing symptoms, or cancer affecting the lining around the brain and spinal cord.
  • The person has, or is at risk of developing, spinal cord compression that is causing symptoms and has not been treated and stabilised for more than 4 weeks.
  • The person has another serious illness or severe infection that could make it unsafe to participate in the trial procedures.

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 8 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: (03) 855 96650

Australian sites

Peter MacCallum Cancer Centre, Melbourne, Victoria

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
Peter MacCallum Cancer Centre, Australia
Registry
ClinicalTrials.gov
Start date
29 September 2022
Est. completion
3 August 2025

Where this trial is recruiting

🇦🇺 Australia

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

Primary endpoints

Maximum Tolerated dose (MTD); Adverse Events (AEs) and Serious Adverse Events (SAEs) measured using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0; Dose Limiting toxicities (DLTs); Recommended Phase 2 Dose (RP2D)

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: 8 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