Radiation Therapy for Prostate Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Prostate Adenocarcinoma+2 MoreRadiation Therapy - Radiation
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial studies how well a PET scan using fluciclovine helps to detect prostate cancer and if site-directed treatment to abnormalities found on the scan works well for treating patients with prostate cancer.

Eligible Conditions
  • Elevated Prostate Specific Antigen (PSA) Level
  • Low PSA Level
  • Prostate Adenocarcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 7 years

At 2 years
Undetectable PSA (< 0.2 ng/mL) rate
Up to 7 years
Median time to reinitiation of antiandrogen therapy (ADT)
Number of patients with PSA < 10 mg/mL and > 3 regions of metastatic prostate cancer on fluciclovine PET/CT
Number of patients with abnormalities within the prostatic fossa with PSA < 10 ng/mL
Number of patients without abnormalities with PSA < 10 ng/mL
Overall survival
Total testosterone

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

Group I (fluciclovine PET/CT)
1 of 3
Group II (surgery, radiotherapy, abiraterone, prednisone)
1 of 3
Group III (abiraterone, prednisone)
1 of 3

Active Control

Experimental Treatment

100 Total Participants · 3 Treatment Groups

Primary Treatment: Radiation Therapy · No Placebo Group · Phase 2

Group II (surgery, radiotherapy, abiraterone, prednisone)Experimental Group · 7 Interventions: Abiraterone, Lymphadenectomy, Computed Tomography, Positron Emission Tomography, Radiation Therapy, Prednisone, Abiraterone Acetate · Intervention Types: Drug, Procedure, Procedure, Procedure, Radiation, Drug, Drug
Group III (abiraterone, prednisone)Experimental Group · 5 Interventions: Abiraterone, Computed Tomography, Positron Emission Tomography, Prednisone, Abiraterone Acetate · Intervention Types: Drug, Procedure, Procedure, Drug, Drug
Group I (fluciclovine PET/CT)ActiveComparator Group · 2 Interventions: Computed Tomography, Positron Emission Tomography · Intervention Types: Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
FDA approved
Lymphadenectomy
2007
Completed Phase 2
~750
Computed Tomography
2017
Completed Phase 2
~3410
Positron Emission Tomography
2008
Completed Phase 2
~2820
Radiation Therapy
2005
Completed Phase 3
~7010
Methylprednisolone
FDA approved
Abiraterone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 7 years

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,595 Previous Clinical Trials
1,568,676 Total Patients Enrolled
Blue Earth DiagnosticsIndustry Sponsor
27 Previous Clinical Trials
2,491 Total Patients Enrolled
Evan YuPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
5 Previous Clinical Trials
236 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The patient must have evidence of prostate cancer in a tissue sample.
The person must not have any previous evidence of cancer that has spread to other parts of the body, as shown by conventional CT and bone scan images.
and must have rising PSA levels (defined as 2 ng/mL or more over a period of 6 months) The patient must have previously undergone radiation therapy to the prostatic fossa and whole pelvis
Patients must have a total testosterone level greater than 120 ng/dL within 28 days of enrollment.
A patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 in order to be eligible for the study.
The patient has an absolute neutrophil count of 1.0 x 10^9/L or greater.
The patient must have undergone a radical prostatectomy previously.
Platelet count is greater than or equal to 100,000.
The PSA doubling time must be calculated utilizing all PSA measurements from most recent biochemically-recurred (BCR)