Comparison of 177Lu-PSMA-617 and 225Ac-PSMA-617

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorThomas Hope

About this trial

There is evidence that Actinium-225 Prostate-Specific Membrane Antigen (225Ac-PSMA) has a potentially higher level of efficacy than 177 Lutetium Prostate-Specific Membrane Antigen (177Lu-PSMA) as a radioligand therapy. This single center, pilot study will compare differences in the mechanisms of actinium-225 and lutetium-177 radioligand therapies (RLT) in participants with high or very high risk localized or locoregional prostate cancer planning on undergoing a prostatectomy.

Eligibility criteria

Qualifiers

Histologically confirmed prostate adenocarcinoma.

Willing to undergo prostatectomy with or without lymph node dissection, and candidate for prostatectomy as determined by urologic oncology.

Gleason score of 4+5 disease or higher.

Pelvic nodal metastases on PSMA PET.

Disqualifiers

Has received prior prostate cancer therapy.

Has participated in a study of an investigational therapeutic product and received study treatment or used an investigational device within four weeks of the first dose of treatment.

Dry mouth that impacts the eating of food (i. e. requiring mouthwash prior to eating).

Concurrent serious (as determined by the principal investigator) medical conditions including but not limited to New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation.

Trial design

Treatments tested in this trial

  • 177 Lutetium Prostate-Specific Membrane Antigen 617
  • Actinium-225 Prostate-Specific Membrane Antigen 617
  • Non-investigational, Prostatectomy
  • Prostate Tissue Collection
  • Single-photon emission computed tomography (SPECT)/Computerized tomography (CT)
  • Blood Sample Collection

Treatment groups

45 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Thomas Hope

Lead sponsor

University of California, San Francisco

Sponsor institution

Novartis

Collaborator