A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy

PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

February 22, 2017

Primary Completion Date

October 17, 2022

Study Completion Date

October 17, 2022

Conditions
Prostate Cancer
Interventions
DRUG

Leuprolide Acetate

22.5mg by intramuscular (IM) injection every 3 months

DRUG

Docetaxel

75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.

DRUG

Bicalutamide

bicalutamide (Casodex) 50mg by mouth daily

RADIATION

Radiation

Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.

DRUG

Abiraterone Acetate

Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.

Trial Locations (2)

20016

Johns Hopkins Sibley Memorial Hospital, Washington D.C.

21231

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

All Listed Sponsors
lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

NCT03043807 - A Study of Definitive Therapy to Treat Prostate Cancer After Prostatectomy | Biotech Hunter | Biotech Hunter