Targeted Alpha Therapy With 225Actinium-PSMA-I&T of Castration-resISTant Prostate Cancer (TATCIST).

• Status: Recruiting
• Trial end date: 2024-12-16
• Target enrollment: 0
• Participant gender: Male

Summary

The treatment regimen will consist of 4 doses of 225Ac-PSMA-I&T

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Excel Diagnostics and Nuclear Oncology Center

Criteria

Inclusion Criteria:

• Signing informed consent

• Adenocarcinoma of Prostate proven by histopathology

• Life expectancy of 6 months or more

• Unresectable metastases

• Progressive disease, with docetaxel/cabazitaxel or declined taxane therapy by the patient

• 177Lu-PSMA-617 naive or 177Lu-PSMA-617/177Lu-PSMA-I&T treated

• If BRCA mutations or microsatellite instability is present, patients should have received FDA approved therapies such as PARP inhibitors and pembrolizumab, and progressed

• Castration-resistant disease with confirmed testosterone level ≤50 ng/ml under prior androgen deprivation therapy (ADT)

• Positive 68Ga-PSMA-11 PET/CT for the majority of measurable diseases defined as SUV ≥2.0

• ECOG 0-2

• Hemoglobin concentration ≥ 9.0 g/dL

• Platelet counts ≥100 × 109/L

• White blood cell count ≥ 2.0 × 109/L), ANC>1.5 x109/L

• Glomerular Filtration Rate (GFR) ≥ 60 ml/min

• AST and ALT ≤ 5xULN

• Billirubin ≤ 3x ULN

• Albumin ≥ 25 g/L

• Serum/plasma creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula

• Received at least one ARAT in the past

• Patients on anti-androgen therapy are allowed to continue their treatment at the discretion of their oncologists

Exclusion Criteria:

• Inclusion Criteria:

• Signing informed consent.

• Adenocarcinoma of Prostate proven by histopathology

• Life expectancy of 6 months or more.

• Unresectable metastases.

• Progressive disease, with docetaxel/cabazitaxel or declined taxane therapy by the patient.

• 177Lu-PSMA-617 naive or 177Lu-PSMA-617/177Lu-PSMA-I&T treated.

• If BRCA mutations or microsatellite instability is present, patients should have received FDA approved therapies such as PARP inhibitors and pembrolizumab, and progressed

• Castration resistant disease with confirmed testosterone level ≤50 ng/mlunder prior androgen deprivation therapy (ADT)

• Positive 68Ga-PSMA-11 PET/CT for the majority of measurable disease defined as SUV ≥2.0.

• ECOG 0-2

• Hemoglobin concentration ≥ 9.0 g/dL

• Platelet counts ≥100 × 109/L

• White blood cell count ≥ 2.0 × 109/L), ANC>1.5 x109/L

• Glomerular Filtration Rate (GFR) ≥ 60 ml/min

• AST and ALT ≤ 5xULN

• Billirubin ≤ 3x ULN

• Albumin ≥ 25 g/L.

• Serum/plasma creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula

• Received at least one ARAT in the past.

• Patients on anti-androgen therapy are allowed to continue their treatment at the discretion of their oncologists.

Exclusion Criteria:

• Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm, 177Lu-PSMA-617, 177Lu-PSMA-I&T) or other radionuclide therapy permitted (including 223Ra, 153Sm)

• Urinary tract obstruction as evidenced by Tc-99m DTPA renal scan with diuretics

• Abnormal renal function (eGFR <60 mL/min), baseline Hgb <9g/dL, ANC<1.5 x109/L, platelets <100 x109/L, and PT, INR or PTT ≥1.5xULN

• Persistent baseline dry eye or dry mouth from prior RLT

• Persistent prior AEs >Grade 1 from prior anti-cancer therapies

• Administration of an investigational agent ≤60 days or 5 half-lives, whichever is shorter, prior to randomization

• The known presence of central nervous system metastases

• Active malignancy other than low-grade non-muscle-invasive bladder cancer and non-melanoma skin cancer

• Concurrent illness that may jeopardize the patient's ability to undergo study procedures.

• Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression

• Concurrent serious (as determined by the investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure

• Major surgery ≤30 days prior to randomization

• Planning to conceive pregnancy during the treatment and up to 6 months after the last treatment