177Lu-PSMA-617 With Liver Directed Therapy in Metastatic Castration Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of California, San Francisco
About this trial
This is an open label, single arm, phase 1b study to determine the safety of combining sequential Prostate-Specific Membrane Antigen (PSMA)-targeted 177Lu-PSMA-617 radionuclide therapy with liver-directed therapy in metastatic castrate-resistant prostate cancer (mCRPC) patients with liver metastases amenable to liver-directed therapy who have progressed on at least one prior androgen pathway inhibitor.
Eligibility criteria
Qualifiers
Histologically confirmed prostate cancer.
Progressive disease by PCWG3 criteria at study entry.
Male participants who are at least 18 years of age on the day of signing informed consent.
Castrate level of serum testosterone at study entry (< 50 ng/dL). Note: Participants without prior bilateral orchiectomy are required to remain on Luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study treatment.
Disqualifiers
De novo small cell neuroendocrine prostate cancer.
One or more extrahepatic soft tissue lesions (lymph nodes > 1.5 cm in short axis, visceral/soft tissue lesions > 1 cm) on screening CT that is negative on PSMA PET. Non- PSMA avid liver lesions are allowed.
Recipient of other systemic anti-cancer therapies administered within 14 days, or 5 half lives, whichever is shorter, prior to initiation of study treatment. Note: LHRH analogues are the exception and are permitted
Recipient of prior PSMA-directed radioligand treatment.
Trial design
Treatments tested in this trial
- 177Lu-PSMA-617
- Ablation
- Trans-arterial chemoembolization (TACE)
- Positron Emission Tomography (PET)/Computerized tomography (CT)
- Tumor Biopsy
- Questionnaire
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, San Francisco
Lead sponsor
Novartis
Collaborator
Source ClinicalTrials.gov