BAMF Health Clinical Trials

Protocol Title: A Multi-Center, Open-Label, Randomized Phase 3 Trial Comparing the Safety and Efficacy of 177Lu-PSMA-I&T versus Hormone Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer

Short Name: ECLIPSE Trial

Sponsor: Curium

Description: This is a prospective, open-label, multi-center, randomized, Phase 3 study evaluating Lutetium 177Lu-PSMA-I&T as treatment compared to standard of care hormone therapy in men with metastatic Castration-Resistant Prostate Cancer.

The study will include a total of 400 patients with metastatic prostate cancer and documented positive PSMA PET imaging. Patients will be randomized at a ratio of 2:1 to receive either 177Lu-PSMA-I&T or hormone therapy (abiraterone or enzalutamide) respectively. Patients randomized to the investigational product will receive up to 4 treatments every 6 weeks at a dose of 200 mCi (7.4 GBq). All patients will be followed for adverse events and safety labs throughout the course of the study. Progression of disease will be assessed radiographically using Prostate Working Group Criteria 3 (PWGC3) and Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of conventional imaging as well as PSA levels and symptom recording throughout the course of treatment.

Patient Enrollment at BAMF: September 12, 2022

Number of patients to be enrolled (study wide): 400

Number of clinical sites in the US: 25 at present

Patient Eligibility Criteria: please click here to see the complete list

In short, men 18 or older with metastatic castration resistant prostate adenocarcinoma without predominant small cell component who have previously been treated with a next-generation androgen receptor-directed therapy and have had progression, but have not had chemotherapy (docetaxel or cabazitaxel).

To get more information or be connected to discuss this clinical trial with someone at BAMF Health, please complete this form

Protocol Title: 64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

Short Name: SABRE Trial

Sponsor: Clarity

Description: SABRE (Copper-64 SAR-BisPSMA in Biochemical Recurrence of prostate cancer) is a Phase II Positron Emission Tomography (PET) imaging trial of participants with PSMA-negative biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-center, single arm, non-randomized, open-label trial of 64Cu-labelled SAR-Bombesin in 50 participants. The primary objectives of the trial are to investigate safety and tolerability of the product as well as its ability to correctly detect recurrence of prostate cancer. The SABRE trial was developed in response to strong demand from clinicians with prostate cancer patients whose cancer was not visible with currently approved PSMA diagnostic agents or conventional imaging (such as CT or MRI).

Patient Enrollment at BAMF: January 12, 2023

Number of patients to be enrolled (study wide): 50

Number of clinical sites in the US: 8 at present

Patient Eligibility Criteria: please click here to see the complete list

To get more information or be connected to discuss this clinical trial with someone at BAMF Health, please complete this form