AAA817 for Prostate Cancer Treatment

Open-label Study Comparing AAA817 Versus Standard of Care in the Treatment of Previously Treated PSMA-positive mCRPC Adults Who Have Disease Progressed on or After [177Lu]Lu-PSMA Targeted Therapy

Recruiting Phase 2 Phase 3 Interventional Study
Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 100
Sex
Male
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Treatment
Participants needed
443 (estimated)
Sponsor
Novartis Pharmaceuticals · Industry
Who this trial is looking for

This trial is looking for adult men with advanced prostate cancer who have not responded to previous treatments. Participants will receive the new treatment, AAA817, or standard care chosen by their doctor.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have prostate cancer that has been confirmed by medical tests.
  • I have had previous treatments with certain cancer medications and therapies.
  • I have low testosterone levels.
  • I have at least one metastatic lesion visible in recent scans.
  • I have a performance status between 0 and 2.
  • I have PSMA-positive disease.
  • I have normal kidney function as required by the study.

You may not be able to join if

  • I have taken any experimental drugs in the last 28 days.
  • I have used any specific investigational compounds before the trial.
  • I have brain metastases that cause symptoms or require steroids.
  • I have recent acute kidney injury or chronic kidney disease.
  • I have severe dry mouth.
  • I have uncontrolled high blood pressure or significant heart issues.
  • I have had a recent heart attack or related heart surgery.
  • I have a history of certain cancers or serious blood disorders in the past 5 years.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This is a Phase II/III study. Patient population is adult participants with PSMA-positive mCRPC who had treatments with androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy and progressed on or after \[177Lu\]Lu-PSMA targeted therapy. Treatment of interest: the investigational treatment is AAA817 regardless of subsequent anti-neoplastic treatment. The control treatment is inve…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: ∙ * adults ≥ 18 years of age. * ECOG performance status of 0 to 2. * histopathological and/or cytological confirmation of adenocarcinoma of the prostate. * PSMA-positive disease as assessed by PSMA PET/CT scan using an approved PSMA imaging agent as protocol instructed, * castra…
Contacts

Novartis Pharmaceuticals

1-888-669-6682

novartis.email@novartis.com

CONTACT

Novartis Pharmaceuticals

+41613241111

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