Health Trials

Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC

ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

The purpose of this study is to determine whether \[225Ac\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +/- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \[177Lu\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent must be obtained prior to participation in the study.

Participants must be adults ≥ 18 years of age.

Participants must have an ECOG performance status of 0 to 2.

Participants must have histological, and/or cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.

Disqualifiers

Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, [177Lu]Lu-PSMA, [177Lu]-DOTA, or Radium- 223.)

Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).

Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AAA817

    Drug

    AAA817 is being studied for treating PSMA positive mCRPC. Inside the body, it attaches itself to PSMA on the cell surface of the prostate cancer cells and emits radiation to kill them. This treatment is also called a radioligand therapy.

  • ARPI

    Drug

    Androgen receptor pathway inhibitor (ARPI): An ARPI is approved for the treatment of prostate cancer. It works by blocking signals from male hormones, such as testosterone, that helps cancer cells grow. By blocking these signals, an ARPI slows down or stops the growth of prostate cancer cells. In this trial, participants will be given either enzalutamide or abiraterone.

  • Standard of Care

    Drug

    Standard treatment includes approved treatment for mCRPC. In this trial, the trial doctor will decide which available treatment participants will receive. The trial doctor will select either an ARPI of enzalutamide or abiraterone, or a taxane based chemotherapy of docetaxel or cabazitaxel or \[177Lu\]Lu-PSMA-617 (AAA617).

Treatment groups

940 Participants
are divided into 3 treatment groups
Group A: Investigational Arm: AAA817+ARPI (enzalutamide or abiraterone)Experimental treatment 2 interventions
Group B: Investigational Arm: AAA817Experimental treatment 1 intervention
Group C: Control arm: Investigator's choice of SoC (ARPI or chemotherapy or AAA617)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Radiographic Progression Free Survival (rPFS)

Time to radiographic disease progression or death due to any cause.

Time frame
From the date of randomization to the date of the first documented radiographic disease progression using conventional imaging, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Secondary outcomes

1

Overall Survival (OS) (Key Secondary Endpoint)

Time to death due to any cause.

Time frame
From the date of randomization to the date of death due to any cause, assessed up to approximately 40 months.
2

Radiographic Progression Free Survival by by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 (Key Secondary)

Time to radiographic disease progression, using by blinded independent central review (BICR) using conventional imaging and Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1 criteria or death due to any cause.

Time frame
From date of randomization to the date of the first documented radiographic disease progression or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.
3

Overall Survival in participants with PSMA-positive mCRPC treated with another ARPI. (Key Secondary)

Time to death due to any cause.

Time frame
From the date of randomization to the date of death due to any cause.
4

rPFS in participants treated with AAA817

rPFS time to the date of first documented radiographic disease progression or death due to any cause, whichever occurs first.

Time frame
From the date of randomization to the date of the first documented radiographic disease progression, or death due to any cause, whichever occurs first, assessed up to approximately 40.0 months.

Other outcomes

Sponsors and contacts

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Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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