Evofosfamide for Prostate Cancer
(EVO Trial)
Trial Summary
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications, but it mentions that participants must not take certain medications that affect the liver enzyme CYP3A4 within 14 days before starting the trial. It's best to discuss your current medications with the trial team to see if any adjustments are needed.
How is the drug evofosfamide unique for treating prostate cancer?
What is the purpose of this trial?
This is a single-institution, single-arm, open-label Phase 2 trial evaluating evofosfamide in subjects with M1 CRPC who fail first-line ARSIs. In those progressing after second-line Docetaxel or deemed ineligible to it, the use of alternate ARSI remains the most common line of therapy in our Province, in keeping with recent international recommendations. After baseline molecular imaging (PSMA and fluorodeoxyglucose (FDG) PET/CT), prior to evofosfamide initiation, subjects will be encouraged to undergo biopsy of a dominant lesion: FDG-, PSMA-uptake and/or conventional imaging determined (in order, and according to feasibility). Subjects will then receive the alternate ARSI (i.e., different from the one received in first line) as per current standard practice and Provincial drug plan coverage. Additionally, subjects will receive combinatorial evofosfamide at a dose of 480 mg/m2 intravenously (IV) over 60 minutes on Days 1, 8 and 15 of every 28-day cycle. Therapy will continue until disease progression, unacceptable toxicity as a result of evofosfamide, or subject withdrawal. Assessments during evofosfamide treatment will include history, physical exam, and blood tests at each monthly visit to monitor for toxicity. Response and progression will be evaluated by whole-body PSMA PET/CT scan every 8 weeks (± 3 days) and determined using (PE)RECIST v1.1 criteria. PSA, NE markers (e.g., Serum CHGA, NSE), organ function tests (e.g., liver, kidney) and investigational liquid biopsy samples will be followed every cycle (monthly). FDG PET/CT will be performed at baseline, at 6-10 weeks from the date of signing the informed consent form (ICF), and upon progression, irrespective of treatment discontinuation or initiation of another therapy. Subjects will be followed for survival endpoints following completion of this study treatment until death.
Eligibility Criteria
This trial is for men with metastatic castrate-resistant prostate cancer (M1 CRPC) who have not responded to first-line ARSI treatments. Candidates should be ineligible for or have progressed after second-line Docetaxel therapy. They must undergo baseline molecular imaging and are encouraged to biopsy a dominant lesion before starting the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Imaging and Biopsy
Baseline molecular imaging (PSMA and FDG PET/CT) and optional biopsy of a dominant lesion
Treatment
Participants receive alternate ARSI and evofosfamide at a dose of 480 mg/m2 IV on Days 1, 8, and 15 of every 28-day cycle
Follow-up
Participants are monitored for survival endpoints following completion of study treatment until death
Treatment Details
Interventions
- Evofosfamide
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
ImmunoGenesis
Industry Sponsor