abiraterone decanoate for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate Cancer+2 Moreabiraterone decanoate - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a new drug for prostate cancer that is given as a shot.

Eligible Conditions
  • Prostate Cancer
  • Meckel's Cave Syndrome with Partial Cerebellar Agenesis (mCSPC)
  • Metastatic Castration-Resistant Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: Treatment

Treatment
Determination of recommended Phase 2 dose (RP2D)
Evaluate pharmacokinetics (PK) profile of PRL-02
Safety (adverse events)
Safety and tolerability
Testosterone suppression

Trial Safety

Safety Progress

1 of 3

Similar Trials

Trial Design

6 Treatment Groups

Cohort 5
1 of 6
Dose Expansion
1 of 6
Cohort 3
1 of 6
Cohort 1
1 of 6
Cohort 2
1 of 6
Cohort 4
1 of 6

Experimental Treatment

100 Total Participants · 6 Treatment Groups

Primary Treatment: abiraterone decanoate · No Placebo Group · Phase 1 & 2

Cohort 5Experimental Group · 3 Interventions: PRL-02, Prednisone, dexamethasone · Intervention Types: Drug, Drug, Drug
Dose Expansion
Drug
Experimental Group · 1 Intervention: abiraterone decanoate · Intervention Types: Drug
Cohort 3Experimental Group · 4 Interventions: abiraterone decanoate, PRL-02, Prednisone, dexamethasone · Intervention Types: Drug, Drug, Drug, Drug
Cohort 1Experimental Group · 4 Interventions: abiraterone decanoate, PRL-02, Prednisone, dexamethasone · Intervention Types: Drug, Drug, Drug, Drug
Cohort 2Experimental Group · 4 Interventions: abiraterone decanoate, PRL-02, Prednisone, dexamethasone · Intervention Types: Drug, Drug, Drug, Drug
Cohort 4Experimental Group · 4 Interventions: abiraterone decanoate, PRL-02, Prednisone, dexamethasone · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2020
Completed Phase 4
~2450
dexamethasone
1995
Completed Phase 3
~9860

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: treatment

Who is running the clinical trial?

Propella TherapeuticsLead Sponsor
2 Previous Clinical Trials
242 Total Patients Enrolled
Jackie Walling, MBChB, Ph.DStudy DirectorConsulting JW, LLC/Propella Therapeutics

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have castration sensitive prostate cancer (CSPC) with oligometastatic prostate cancer (e.g.
You have metastatic castration resistant prostate cancer (mCRPC).
You have a positive CTC count of ≥5 cells/7.5 mL blood at screening.
You have measurable disease according to RECIST v1.1 and a target lesion ≥1 cm in size at screening.
You have a PSA value of 2 µg/L (2 ng/mL) or higher.
You have given informed consent prior to any study-related procedure being performed.
You are male and at least 18 years of age or older at time of consent.
You have histological evidence of adenocarcinoma of the prostate.
You have metastatic castration sensitive prostate cancer.