Study to Assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Participants With PSMA-positive HRLPC
Launched by NOVARTIS PHARMACEUTICALS · Mar 11, 2025
Trial Information
Current as of August 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at two experimental treatments, called AAA602 and AAA802, for men with a specific type of prostate cancer known as high-risk localized prostate cancer (HRLPC). The goal is to see how these treatments work before surgery to remove the prostate and nearby lymph nodes, which are small organs that help your body fight infections. The trial is currently not recruiting participants, but it aims to learn more about how these treatments can help men whose prostate cancer is linked to a protein called PSMA.
To be eligible for this trial, participants must be adult males aged 18 and older who have been diagnosed with PSMA-positive high-risk prostate cancer. This means their cancer has certain characteristics that put them at higher risk. They must also have good overall health, particularly in terms of their blood counts and organ function. Participants will undergo a series of assessments and treatments, and it's important to note that they will need to follow specific guidelines about contraception if they are sexually active. Overall, the trial seeks to provide valuable information that could improve treatment options for men facing this type of cancer.
Gender
MALE
Eligibility criteria
- Inclusion Criteria:
- • Adults ≥ 18 years of age.
- • Participants must have PSMA-positive disease as assessed by PSMA PET/CT scan using a PSMA imaging agent as protocol instructed, with eligibility being determined by the sponsor's central reading rules.
- • Histologically confirmed high-risk adenocarcinoma of an intact prostate, and (a) 1 of the following at diagnosis: Gleason score ≥ 8 and/or PSA ≥ 20 nanogram per milliliters (ng/mL), and/or ≥ cT3a or (b) Gleason score 4+3 and PSA ≥ 20 nanogram per milliliters (ng/mL).
- * Adequate organ function:
- * Bone marrow reserve:
- • White blood cell (WBC) count ≥ 3.0 x 109/L and absolute neutrophil count (ANC) ≥ 1.5 x 109/L.
- • Platelets ≥ 75 x 109/L.
- • Hemoglobin ≥ 8 g/dL
- * Hepatic function:
- • Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome ≤ 3 x ULN is permitted.
- • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN
- • Albumin \> 3.0 g/dL
- * Renal function:
- • Creatinine clearance ≥ 60 mL/min. Note that participants with findings indicating blockage of urinary outflow are not eligible. No evidence of congenital renal abnormalities with known effect on renal function or voiding abnormalities that may interfere, in the opinion of the principal investigator, with the safe administration of the study treatment.
- • An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- • Indicated to receive radical prostatectomy (RP) and pelvic lymph node dissection (PLND).
- * Sexually active participants with female partners of childbearing potential are eligible to participate if they agree to follow one of the following methods of contraception consistently, starting from screening, during the study and for at least 6 months after the last dose of study treatment:
- • Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
- • Are sterilized (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate);
- • Agree to use a male condom and have their partner use a highly effective method of contraception (failure rate \< 1% per year) as described in Section 8.4.6 when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant, and who agrees to the use of a condom by her partner.
- • In addition, participants must refrain from donating sperm starting from Screening, during the study and for at least 6 months after the last dose of the study medication.
- • Sexually active participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse; or use a male condom during each episode of penile penetration during the study.
- Exclusion Criteria:
- • Subjects taking prohibited therapies as described in the protocol
- • Any approved or investigational systemic anti-cancer therapy (e.g. chemotherapy, investigational therapy, immunotherapy or biological therapy including monoclonal antibodies) administered for the treatment of HRLPC within 28 days (or 5 times the half-life of that therapy whichever is longer) of the anticipated day C1D1.
- • Previous treatment with any approved or investigational radioligand therapy, approved or investigational radioisotopes.
- • Prior or concurrent radiation therapy of the prostate, other prostate antineoplastic ablative procedures, or hormonal ablation for prostate cancer.
- • Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment. Participants with a prior history of malignancy that has been adequately treated and who have been disease free and treatment free for more than 3 years prior to randomization are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer.
- • Other protocol-defined Inclusion/exclusion may apply.
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported