Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC
Recruiting · NCT06855277 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
AAA817ARPIStandard of Care
What this trial is about
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.
Who can take part
Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
- ther protocol-defined inclusion/exclusion criteria may apply.
Where it is running
60 locations listed across 22 US states.
- Urology Centers Of Alabama Pc - Homewood, Alabama, United States
- Stanford University Medical Center - Palo Alto, California, United States
- Sansum Clinic - Santa Barbara, California, United States
- Rocky Mountain Cancer Centers - Denver, Colorado, United States
- Florida Cancer Specialists - Fort Myers, Florida, United States
- Baptist Health South - Miami, Florida, United States
- AdventHealth - Orlando, Florida, United States
- University Cancer and Blood Center LLC - Athens, Georgia, United States
- Northwestern University - Chicago, Illinois, United States
- University of Illinois Cancer Center at Chicago - Chicago, Illinois, United States
- Univ Of Iowa Hospitals And Clinics - Iowa City, Iowa, United States
- University of Kansas Hospital - Kansas City, Kansas, United States
- East Jefferson Hospital - Metairie, Louisiana, United States
- Beth Israel Deaconess Med Center - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Karmanos Cancer Institute - Detroit, Michigan, United States
- Wash U School of Medicine - St Louis, Missouri, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Astera Cancer Center - East Brunswick, New Jersey, United States
- New Jersey Urology LLC - Voorhees Township, New Jersey, United States
- New Mexico Oncology Hematology - Albuquerque, New Mexico, United States
- Bassett Medical Center - Cooperstown, New York, United States
- Weill Cornell Medicine NY-Presb - New York, New York, United States
- University of Rochester Medical Ctr - Rochester, New York, United States
- Associated Med Professionals of NY - Syracuse, New York, United States
- Montefiore Medical Center - The Bronx, New York, United States
- Urology Group - Solaris Network - Cincinnati, Ohio, United States
- Central Ohio Urology Group - Gahanna, Ohio, United States
- MUSC Hollings Cancer Center - Charleston, South Carolina, United States
- Carolina Urologic Research Center - Myrtle Beach, South Carolina, United States
- Tennessee Oncology PLLC - Chattanooga, Tennessee, United States
- Urology San Antonio - San Antonio, Texas, United States
- Woodlands Cancer Institute American Oncology Partners - The Woodlands, Texas, United States
- Swedish Medical Center - Seattle, Washington, United States
- Northwest Medical Specialties - Tacoma, Washington, United States
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States
- Novartis Investigative Site - Adelaide, Australia
- Novartis Investigative Site - Beijing, China
- Novartis Investigative Site - Beijing, China
- Novartis Investigative Site - Chiba, Japan
- Novartis Investigative Site - Fukuoka, Japan
- Novartis Investigative Site - Fukuoka, Japan
- Novartis Investigative Site - Fukuoka, Japan
- Novartis Investigative Site - Fukushima, Japan
- Novartis Investigative Site - Guangzhou, China
- Novartis Investigative Site - Hiroshima, Japan
- Novartis Investigative Site - Hong Kong, Hong Kong
- Novartis Investigative Site - Kaohsiung City, Taiwan
- Novartis Investigative Site - Kyoto, Japan
- Novartis Investigative Site - London, United Kingdom
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Seoul, South Korea
- Novartis Investigative Site - Shanghai, China
- Novartis Investigative Site - Shanghai, China
- Novartis Investigative Site - Shanghai, China
- Novartis Investigative Site - Singapore, Singapore
Showing 60 of 93 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →