PCUR-101 Dose Escalation for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Michigan, Ann Arbor, MIProstate CancerPCUR-101 - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trialtests an experimental drug to find the most effective dose to treat prostate cancer that has spread. It uses a 3+3 design to determine the max tolerated dose.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: through study completion, average of 12 months

Day 28
Determination of pharmacokinetic parameters - Cmax
Determination of pharmacokinetic parameters - T1/2
Determination of pharmacokinetic parameters - Tmax
Occurrence of Dose Limiting Toxicity
Month 12
Preliminary Evidence of efficacy/anti tumor activity - PSA levels
Preliminary Evidence of efficacy/anti tumor activity - RECIST

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

PCUR-101 Dose Escalation
1 of 4
PCUR-101 Dose Expansion Cohort 1
1 of 4
PCUR-101 Dose Expansion Cohort 2
1 of 4
PCUR-101 Dose Expansion Cohort 3
1 of 4

Experimental Treatment

48 Total Participants · 4 Treatment Groups

Primary Treatment: PCUR-101 Dose Escalation · No Placebo Group · Phase 1

PCUR-101 Dose Escalation
Drug
Experimental Group · 1 Intervention: PCUR-101 · Intervention Types: Drug
PCUR-101 Dose Expansion Cohort 1
Drug
Experimental Group · 1 Intervention: PCUR-101 · Intervention Types: Drug
PCUR-101 Dose Expansion Cohort 2Experimental Group · 2 Interventions: PCUR-101, Dutasteride 0.5 mg · Intervention Types: Drug, Drug
PCUR-101 Dose Expansion Cohort 3Experimental Group · 2 Interventions: PCUR-101, Abiraterone and Prednisone · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dutasteride
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, average of 12 months

Who is running the clinical trial?

Pellficure Pharmaceuticals, IncLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 3 more months.

Frequently Asked Questions

Are applicants still being considered for this research endeavor?

"As indicated by records on clinicaltrials.gov, the hunt for participants is still underway. The trial was initially publicized on March 30th 2021 and recently updated as of October 20th 2022." - Anonymous Online Contributor

Unverified Answer

Has research on PCUR-101 Dose Expansion Cohort 3 been conducted previously?

"Presently, there are 371 ongoing studies exploring PCUR-101 Dose Expansion Cohort 3 with 102 of those trials being in the Phase 3 stage. Most experiments for PCUR-101 Dose Expansion Cohort 3 take place out of Duarte, California though a remarkable number of 17,427 locations host clinical trials related to this topic." - Anonymous Online Contributor

Unverified Answer

What is the projected number of participants for this trial?

"Affirmative. Clinicaltrials.gov documents that this research trial is still searching for participants since its first posting on March 30th 2021, with the last update taking place October 20th 2022. 48 applicants are required from a single location to complete the study." - Anonymous Online Contributor

Unverified Answer

What medical condition does PCUR-101 Dose Expansion Cohort 3 usually address?

"PCUR-101 Dose Expansion Cohort 3 is a viable course of action for treating thyroiditis, ulcerative colitis, and various malignant tumors." - Anonymous Online Contributor

Unverified Answer

Has the PCUR-101 Dose Expansion Cohort 3 been granted official clearance by the FDA?

"The safety of PCUR-101 Dose Expansion Cohort 3 was rated at a 1 due to it being in the initial stages of development, meaning there is limited evidence on its efficacy and safety." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.