N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT06855277

Registry updated: 2026-10-15
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • 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).

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.

Conditions

Prostate Cancer

Locations

  • Urology Centers Of Alabama Pc — Homewood, Alabama, United States
  • University of Arizona — Tucson, Arizona, United States
  • Univ Cali Irvine ALS Neuromuscular — Orange, California, 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
  • New England Cancer Specialists — Scarborough, Maine, United States
  • Johns Hopkins Hospital — Baltimore, Maryland, 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 Austin — Lakeway, Texas, 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
  • West Virginia University Hospital — Morgantown, West Virginia, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Novartis Investigative Site — Darlinghurst, New South Wales, Australia
  • Novartis Investigative Site — Adelaide, South Australia, Australia
  • Novartis Investigative Site — Malvern, Victoria, Australia
  • Novartis Investigative Site — Murdoch, Western Australia, Australia
  • Novartis Investigative Site — Adelaide, Australia
  • Novartis Investigative Site — São Paulo, São Paulo, Brazil
  • Novartis Investigative Site — São Paulo, São Paulo, Brazil
  • Novartis Investigative Site — Fuzhou, Fujian, China
  • Novartis Investigative Site — Guangzhou, Guangdong, China
  • Novartis Investigative Site — Guangzhou, Guangdong, China
  • Novartis Investigative Site — Wuhan, Hubei, China
  • Novartis Investigative Site — Wuhan, Hubei, China
  • Novartis Investigative Site — Nanjing, Jiangsu, China
  • Novartis Investigative Site — Nanjing, Jiangsu, China
  • Novartis Investigative Site — Shenyang, Liaoning, China
  • Novartis Investigative Site — Chengdu, Sichuan, China
  • Novartis Investigative Site — Hangzhou, Zhejiang, China
  • Novartis Investigative Site — Hangzhou, Zhejiang, China
  • Novartis Investigative Site — Beijing, China
  • Novartis Investigative Site — Beijing, China
  • Novartis Investigative Site — Guangzhou, China
  • Novartis Investigative Site — Shanghai, China
  • Novartis Investigative Site — Shanghai, China
  • Novartis Investigative Site — Shanghai, China
  • Novartis Investigative Site — Tianjin, China
  • Novartis Investigative Site — Tianjin, China
  • Novartis Investigative Site — Hong Kong, Hong Kong
  • Novartis Investigative Site — Gurgaon, Haryana, India
  • Novartis Investigative Site — Bengaluru, Karnataka, India
  • Novartis Investigative Site — Mumbai, Maharashtra, India
  • Novartis Investigative Site — Nagoya, Aichi-ken, Japan
  • Novartis Investigative Site — Sapporo, Hokkaido, Japan
  • Novartis Investigative Site — Kobe, Hyōgo, Japan
  • Novartis Investigative Site — Kobe, Hyōgo, Japan
  • Novartis Investigative Site — Kamakura, Kanagawa, Japan
  • Novartis Investigative Site — Yokohama, Kanagawa, Japan
  • Novartis Investigative Site — Kumamoto, Kumamoto, Japan
  • Novartis Investigative Site — Chuo Ku, Tokyo, Japan
  • 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 — Hiroshima, Japan
  • Novartis Investigative Site — Kyoto, Japan
  • Novartis Investigative Site — Mexico City, Mexico
  • Novartis Investigative Site — Singapore, Singapore
  • Novartis Investigative Site — Singapore, Singapore
  • Novartis Investigative Site — Singapore, Singapore
  • 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 — Kaohsiung City, Taiwan
  • Novartis Investigative Site — Taichung, Taiwan
  • Novartis Investigative Site — Tainan, Taiwan
  • Novartis Investigative Site — Taipei, Taiwan
  • Novartis Investigative Site — Taoyuan, Taiwan
  • Novartis Investigative Site — Oxford, Oxfordshire, United Kingdom
  • Novartis Investigative Site — Sutton, Surrey, United Kingdom
  • Novartis Investigative Site — Windsor, Surrey, United Kingdom
  • Novartis Investigative Site — London, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record