Phase 3 Prostate Cancer Trial, Recruiting NCT06780670 Sponsor: Novartis Pharmaceuticals Condition: Prostate Cancer
Back to Prostate Cancer

Phase 3 Prostate Cancer Trial, Recruiting

NCT06780670
Recruiting Phase 3 🇦🇺 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:

  • Adults aged 18 years or older.
  • People whose general health and ability to carry out daily activities falls within a certain range, as measured by a standard medical scoring system called ECOG (scores 0 to 2, meaning fully active to capable of limited self-care).
  • People who have been confirmed through tissue or cell testing to have prostate adenocarcinoma (a specific type of prostate cancer).
  • People whose cancer shows a certain protein marker called PSMA, confirmed by a specialised scan (PSMA PET/CT).
  • People whose testosterone levels are at a very low "castrate" level, either through medication or surgery.
  • People who have previously been treated with two specific types of cancer therapy — a hormone-blocking drug (called an androgen receptor pathway inhibitor) and a chemotherapy containing taxane — and whose cancer has continued to grow during or after a radioactive treatment called Lutetium-177 PSMA therapy.
  • People who have at least one area of cancer spread (metastasis) visible on a CT scan, MRI, or bone scan done within 28 days before joining the trial.
  • People whose kidney function meets a specific level required by the trial organiser (confirm with trial site).

Who may not be able to join:

  • People who have taken part in another experimental drug trial within 28 days before joining.
  • People who have previously received any experimental treatment containing a substance called Actinium-225 (225Ac).
  • People who have cancer that has spread to the brain or spinal cord and are experiencing neurological symptoms, instability, or are taking steroid medications to manage those symptoms.
  • People who have a current or ongoing kidney injury or kidney disease.
  • People who already have moderate to severe dry mouth (rated Grade 2 or higher on a standard medical scale).
  • People who have a history of uncontrolled high blood pressure, heart attack, chest pain (angina), or heart bypass surgery within the 6 months before signing consent, or who have significant active heart disease.
  • People who have had another type of cancer or a blood/lymph system cancer within the past 5 years — with exceptions for certain treated skin conditions (basal cell carcinoma or actinic keratosis with no recurrence in 3 months, or non-invasive colon polyps that have been removed).

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 22 July 2026
Phase 3: approximately ~65% 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: 1-888-669-6682

Australian sites

Novartis Investigative Site, Darlinghurst, New South Wales
Novartis Investigative Site, Herston, Queensland
Novartis Investigative Site, 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 3
Registry
ClinicalTrials.gov
Start date
27 February 2025
Est. completion
27 June 2028

Where this trial is recruiting

🇦🇺 Australia 🇧🇷 Brazil 🇨🇳 China Hong Kong 🇮🇱 Israel 🇯🇵 Japan 🇲🇾 Malaysia 🇸🇬 Singapore 🇰🇷 South Korea 🇨🇭 Switzerland 🇹🇼 Taiwan 🇺🇸 United States

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

Primary endpoints

Biochemical response rate (Phase II); Adverse Events (AEs) and Serious Adverse Events (SAEs), and deaths - Phase II; Tolerability of the proposed dose of AAA817- Phase II; Radiographic progression-free survival (rPFS)- Phase III; Overall survival (OS)- Phase III

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: 22 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