A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

Launched by CHU DE QUEBEC-UNIVERSITE LAVAL · May 31, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for patients with advanced prostate cancer or other cancers that express a specific protein called PSMA. The treatment involves using a radioactive drug called lutetium-177 (177Lu) to target and help kill cancer cells. The main goal of the study is to create a personalized treatment plan based on how the patient’s kidneys respond to the drug. Participants will receive up to six doses of this therapy, and the researchers will evaluate how well it works in the first year after treatment.

To be eligible for the trial, participants must be adults over 18 years old with cancer that cannot be surgically removed and has progressed recently. They must also show significant levels of PSMA in their tumors. However, people with certain health issues or blood count problems may not qualify. The trial is not yet recruiting, but those who participate can expect close monitoring and the possibility of additional treatment if they respond well to the initial therapy. This trial aims to provide valuable insights into a personalized approach to treating challenging cancers.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • \>18 y.o. adults able to provide consent
• • Inoperable or metastatic PSMA-expressing cancer, with significant PSMA expression defined as uptake in at least one lesion that is superior to that of the liver on PSMA positron-emission tomography (PET) within 3 months prior to enrolment
• • Cancer progression documented within 3 months prior to enrolment as per the investigator's assessment, without initiation of another anti-cancer treatment since (excluding palliative radiation therapy to a minority of the tumor burden), unless that anti-cancer treatment was stopped prematurely because of intolerance
• • For participants with a cancer other than mCRPC, a recommendation from a multidisciplinary tumor board (MDT) in favor of PSMA RPT must be obtained
• Exclusion Criteria:
• • Platelets \< 50 x 106/L
• • Absolute neutrophil count (ANC) \< 1.0 x 106/L
• • Eastern Cooperative Oncology Group (ECOG) 4 or prognosis \< 3 months, for cancer-related or other serious medical conditions, as per investigator's assessment
• • Known presence of central nervous system metastasis at risk of complication, which cannot be adequately stabilized (e.g. radiotherapy or corticoid prophylaxis), as per investigator's assessment
• • Any condition that would limit the ability to comply with the study protocol, as per investigator's assessment
• • Pregnancy or breastfeeding (e.g. for female participants with non-prostate cancer)