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Virus Therapy

PCUR-101 + ADT for Prostate Cancer

Phase 1

Waitlist Available

Research Sponsored by Pellficure Pharmaceuticals, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, average of 12 months

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, average of 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, average of 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Dose Limiting Toxicity

Secondary outcome measures

Determination of pharmacokinetic parameters - Cmax

Determination of pharmacokinetic parameters - T1/2

Determination of pharmacokinetic parameters - Tmax

+2 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: PCUR-101 Dose Expansion Cohort 3Experimental Treatment2 Interventions

PCUR-101 dosed orally once per day in combination with abiraterone (once per day) and prednisone (twice per day) in 28 day cycles

Group II: PCUR-101 Dose Expansion Cohort 2Experimental Treatment2 Interventions

PCUR-101 in combination with dutasteride dosed orally once per day in 28 day cycles

Group III: PCUR-101 Dose Expansion Cohort 1Experimental Treatment1 Intervention

PCUR-101 dosed orally once per day in 28 day cycles

Group IV: PCUR-101 Dose EscalationExperimental Treatment1 Intervention

PCUR-101 dosed orally once per day in 28 day cycles. Patients will be enrolled into escalating dose levels during the dose escalation phase

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dutasteride

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pellficure Pharmaceuticals, IncLead Sponsor

1 Previous Clinical Trials

12 Total Patients Enrolled

Media Library

PCUR-101 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04677855 — Phase 1

Prostate Cancer Research Study Groups: PCUR-101 Dose Expansion Cohort 3, PCUR-101 Dose Escalation, PCUR-101 Dose Expansion Cohort 1, PCUR-101 Dose Expansion Cohort 2

Prostate Cancer Clinical Trial 2023: PCUR-101 Highlights & Side Effects. Trial Name: NCT04677855 — Phase 1

PCUR-101 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04677855 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of PCUR-101 in Combination With ADT in Patients With mCRPC

2021. "Study of PCUR-101 in Combination With ADT in Patients With mCRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04677855.