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NeoPSMA: A Phase I/II, open-label, multi-center study of neoadjuvant treatment with [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in adults with prostate-specific membrane antigen (PSMA) positive high-risk localized prostate cancer (HRLPC) prior to radical prostatectomy and pelvic lymph node dissection (CAAA802B12101)

Study to assess [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in participants with PSMA-positive HRLPC (CAAA802B12101)

Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku2@novartis.com

Yamauchi Kyosuke

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku2@novartis.com

Complete

June. 27, 2025

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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 Gleason score >= 8 and/or PSA > 20 nanogram per milliliters (ng/mL) and/or >= cT3a.
Adequate organ function:
Bone marrow reserve:
White blood cell (WBC) count >= 3.0 x 10*9/L and absolute neutrophil count (ANC) >= 1.5 x 10*9/L.
Platelets >= 75 x 10*9/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.

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.

Male

Prostate Cancer

Drug: AAA602
[177]Lu-PSMA-R2 Radiopharmaceutical solution for injection/infusion.
AAA602 will be administered as a single intravenous dose.
Drug: AAA802
[225]Actinium-PSMA-R2 radiopharmaceutical solution for injection/infusion
AAA802 will be administered as a single intravenous dose
Drug: Gallium (68Ga) gozetotide, Solution for injection.
Radioligand Imaging compound.

Number of participants with dose-limiting toxicities (DLTs) (Phase l)
Biochemical recurrence free survival (BFS) (Phase ll)

+81-3-3542-2511

May. 14, 2025

Yes

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.

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