TheranosticTrials.org

Clinical Trial · NCT05567770

ACTInium-J591 Radionuclide Therapy in PSMA-Detected Metastatic HOrmone-Sensitive Recurrent Prostate CaNcer

Overview

The purpose of this study is to evaluate the safety of combining Actinium- J591 with radiation therapy or with androgen deprivation therapy.

Sponsor

Weill Medical College of Cornell University

Phase

Phase 1

Contacts

Himanshu Nagar, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05567770

Drug / Compound

J591

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Antibodies
Chelator: DOTA

Eligibility

Inclusion

  • To have adequate organ and marrow function, as defined below:
  • ECOG Performance Status 0-2.
  • Serum total testosterone \>100 ng/dL within 120 days prior to enrollment.
  • c. Platelet count ≥150,000/mm3 and absent history or primary quantitative or qualitative platelet defect
  • Prior curative-intent treatment to the prostate, by either:
  • PSMA PET scan (Must be positive with exception of local disease); Note: All 3 scans are mandatory (bone scan; CT/MR; PET)
  • e. Serum total bilirubin ≤1.5 x ULN (unless due to Gilbert's syndrome, in which case direct bilirubin must be normal)
  • Either CT or MRI of pelvis +/- abdomen (Must be negative or equivocal);
  • a. Absolute neutrophil count (ANC) of ≥2,000/mm3
  • Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration.
  • 99mTc bone scan (Must be negative or equivocal);
  • External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites.
  • f. Serum AST and ALT ≤1.5 x ULN.
  • Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes.
  • d. Serum creatinine of ≤1.5 x ULN or calculated creatinine clearance of ≥60 mL/min/1.73 m2 by Cockcroft-Gault (or determined by 24 hour urine collection)
  • b. Hemoglobin ≥9 g/dL without need for transfusion

Exclusion

  • 1\. Currently on androgen deprivation or anti-androgen therapy.
  • a. osseous metastasis on 99mTc radionuclide bone scan, or
  • Intrapelvic lymph nodes as only site of prostate cancer recurrence.
  • History of prior PSMA-TRT
  • Prior treatment with unsealed radiation sources such as 89Strontium or 153Samarium-containing compounds (e.g. Metastron, Quadramet)
  • b. extra pelvic nodal/soft tissue disease (\> 1.5cm in short axis) on CT or MRI pelvis +/- abdomen
  • Prior chemotherapy for prostate cancer or bilateral orchiectomy. Note: Prior chemotherapy for a different cancer is allowed if continuously disease-free for \> 3 years.