RightFit
RecruitingPhase 3

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

A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Screening period: At screening, the participants will be assessed for eligibility and will undergo a positron emission tomography (PET)/computed tomography (CT) scan to evaluate PSMA positivity."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares AAA817 plus an ARPI, a drug that blocks male hormone signals, with standard treatments. It tests whether this treatment keeps cancer from getting worse on scans for longer. It is for adults with prostate cancer that has spread, grows despite low testosterone, and shows PSMA, a protein, on a PET scan.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and sign a form agreeing to join the study.
  • Be able to do self-care and be out of bed or a chair for at least half of waking hours.
  • Have prostate adenocarcinoma, a type of prostate cancer, confirmed by tissue or cell testing.
  • Have cancer that shows PSMA on a PET scan using an approved imaging drug.
  • Have cancer that has spread and grows despite low testosterone. It must have worsened during your last treatment with an ARPI given before the cancer became resistant to hormone treatment.
  • Your cancer must not have worsened on more than one ARPI.
  • Have had no taxane chemotherapy after the cancer became resistant to hormone treatment. Earlier taxane treatment may be allowed if the study doctor finds a study treatment suitable.
  • People with certain harmful or likely harmful changes in DNA-repair genes called HRR may join if they previously received a PARP inhibitor. See the conflicting exclusion rule below.

Who can't join

  • Have prostate cancer with mixed cell types, including neuroendocrine cells.
  • Have had cancer treatment with radioactive drugs, such as lutetium-based treatments or radium-223.
  • Have had radiation from a machine within 6 weeks before random treatment assignment, or within 2 weeks for radiation to specific spots where cancer spread.
  • Have had a PARP inhibitor or other whole-body cancer treatment for cancer that has spread and resists hormone treatment. This conflicts with the HRR gene rule above; ask the study team to clarify.
  • Have had another approved or experimental whole-body cancer treatment too recently: within 28 days or 5 drug half-lives, whichever is shorter. A half-life is the time it takes half the drug to leave the body. An ARPI started earlier may continue until the first study treatment day.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * 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. * Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded. * Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting). * Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol. * Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI). * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi. Key Exclusion Criteria: * 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. Note: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1. Other protocol-defined inclusion/exclusion criteria may apply.

Study sites (42)

AL

AZ

CA

CO

FL

GA

IA

IL

KS

LA

MA

MD

ME

MI

MO

NE

NJ

NM

NY

OH

SC

TN

TX

WA

WI

WV