Leuprolide acetate for Advanced Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Prostate Cancer+4 MoreLeuprolide acetate - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is testing a combination of therapies to treat prostate cancer.

Eligible Conditions
  • Advanced Prostate Cancer
  • Prostate Cancer Recurrence
  • Prostate Cancer
  • Prostate Cancer (Stage III)
  • Stage IIB Prostate Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline up to 1 year

Year 1
Quality of life (QoL), measured using the EPIC, AUA symptom index, and the PROMIS Fatigue Scale
Month 6
Change in PSA levels
Month 1
Acute toxicities, monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Treatment (enzalutamide, radiation therapy, hormone therapy)
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Leuprolide acetate · No Placebo Group · Phase 1

Treatment (enzalutamide, radiation therapy, hormone therapy)Experimental Group · 4 Interventions: Leuprolide acetate, Goserelin acetate, Radiation therapy, Enzalutamide · Intervention Types: Drug, Drug, Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide
FDA approved
Goserelin
FDA approved
Radiation therapy
2013
Completed Phase 3
~2840
Enzalutamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 1 year

Who is running the clinical trial?

Astellas Pharma IncIndustry Sponsor
679 Previous Clinical Trials
213,292 Total Patients Enrolled
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,217 Total Patients Enrolled
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor
162 Previous Clinical Trials
11,582 Total Patients Enrolled
Robert Den, MDPrincipal InvestigatorThomas Jefferson University
3 Previous Clinical Trials
85 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
This means that the person has prostate cancer that has not spread to other parts of the body, but the cancer is quite advanced, with a Gleason score of 7 or higher, a PSA level of 10 ng/ml or higher, or a tumor that is at least 2.0 cm in size.
A total bilirubin level that is lower than the upper limit of normal, with the exception of Gilbert's disease, is considered acceptable.
The ALT (SGPT) is less than 1.5 times the ULN.
You have AST (SGOT) < 1.5 x ULN.
You have a performance status of 0 or 1.
A person's absolute neutrophil count is more than 1,500 per millimeter cubed.
Hemoglobin > 8.0 g/dl.
The person's platelet count is more than 100,000 per millimeter cubed.