Prostate Cancer study: Investigators choice of SoC vs AAA817
Official title 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
ClinicalTrials.gov ID: NCT06780670
What this study is testing
What is Investigator's choice of Standard of Care?
This is a group of standard treatments being studied as a comparison option for prostate cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether AAA817 helps men with advanced prostate cancer who have already tried other therapies.
- Who it's for
- You may be able to join if you are an adult man with advanced prostate cancer that has spread and has tried other treatments, including a specific targeted therapy.
- What's involved
- You would receive the drug AAA817 or the treatment chosen by your doctor. You will have regular visits and tests to check your health.
- Time commitment
- The study lasts about 12 months, with visits every few weeks to monitor progress.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100, men only
You may be able to join if
- 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,
- castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
You likely can't join if
- Any investigational agents within 28 days prior to the day of randomization.
- Any 225Ac-based investigational compound used prior to the day of randomization.
- Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of...
- Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal...
- Baseline xerostomia ≥ Grade 2 by CTCAE v.5
- History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to...
See the full eligibility 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,
- castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L).
- Prior treatments with an androgen receptor pathway inhibitor (ARPI) and taxane-based chemotherapy, and progressed on or after [177Lu]Lu-PSMA targeted therapy.
- ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization
- eGFR as requested by the sponsor
- Any investigational agents within 28 days prior to the day of randomization.
- Any 225Ac-based investigational compound used prior to the day of randomization.
- Participants with a history of CNS metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
- Concurrent acute kidney injury (renal failure developed between 48 hours to 7 days) or chronic kidney disease (at least 3 months of ongoing renal injury)
- Baseline xerostomia ≥ Grade 2 by CTCAE v.5
- History of uncontrolled hypertension, myocardial infarction (MI), angina pectoris, or coronary artery bypass graft (CABG) within 6 months prior to ICF signature and/or clinically active significant cardiac disease
- History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 2 years (except for basal cell carcinoma or actinic keratosis that have been treated with no...
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Santa Barbara, California, United States
- Santa Monica, California, United States
- Denver, Colorado, United States
- Hartford, Connecticut, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Athens, Georgia, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Kansas City, Kansas, United States
- Metairie, Louisiana, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Voorhees Township, New Jersey, United States
- New York, New York, United States
+ 54 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; Santa Barbara, California, United States; Santa Monica, California, United States; Denver, Colorado, United States and 68 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.