Study Summary
This trial is testing a new drug for prostate cancer that has spread and is resistant to hormone therapy. They will study how well the drug works and if it is safe.
- Metastatic Castration Resistant Prostate Cancer
- Castration-resistant Prostate Cancer
- Prostate Cancer
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 9 Secondary · Reporting Duration: 3 years
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
3 Treatment Groups
Dose Escalation
1 of 3
Backfill Expansion
1 of 3
Expansion
1 of 3
Experimental Treatment
90 Total Participants · 3 Treatment Groups
Primary Treatment: Dose Escalation · No Placebo Group · Phase 1
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 100 · Male Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Frequently Asked Questions
Does this trial encompass participants aged 20 and above?
"This research endeavour is accommodating people aged 18 and up to 100 years old." - Anonymous Online Contributor
Has the FDA sanctioned dose escalation as a viable therapeutic approach?
"The limited data available suggests that Dose Escalation is safe enough to receive a score of 1 on our team's internal scale. This Phase 1 trial does not provide ample evidence for either efficacy or safety." - Anonymous Online Contributor
Are there any openings for participants in this clinical investigation?
"Affirmative. According to information hosted on clinicaltrials.gov, the medical trial is still actively seeking out qualified candidates since its initial posting date of September 15th 2022 and last update of September 20th 2022. The research requires 90 participants at one locale for enrollment." - Anonymous Online Contributor
How many participants are currently included in the experimental protocol?
"Affirmative. The clinical trial is actively recruiting, as evidenced by the data on clinicaltrials.gov which was first posted on September 15th 2022 and most recently updated on September 20th 2022. 90 patients are sought from one medical centre." - Anonymous Online Contributor
For whom is this clinical experiment accessible?
"This clinical trial is seeking 90 male participants aged 18 and above who are suffering from castration-resistant prostatic cancer. To qualify, they must have progressed after one novel anti-androgen therapy and a taxane containing regimen (or be medically ineligible to receive it). Additionally, the tumor must express PSMA, with adequate organ function being necessary as well as histological or cytological confirmation of prostate adenocarcinoma." - Anonymous Online Contributor