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A Study of Definitive Therapy to Treat Prostate Cancer

NCT02716974 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2022-08-04

Study results available
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Summary

To assess the safety of treating men with oligometastatic prostate cancer with the following therapy: (1st) Systemic chemo-hormonal therapy with up to 6-months (\~24 weeks) of neoadjuvant androgen deprivation and up to 6 cycles of chemotherapy, (2nd) definitive local tumor control with prostatectomy +/- adjuvant radiation therapy, and (3rd) consolidative stereotactic radiation to oligometastatic lesions. The men will receive a total of 1 year of androgen deprivation. Androgen blockade will be the same throughout the course of treatment.

Conditions

Interventions

DRUG

Leuprolide Acetate

22.5mg by intramuscular (IM) injection every 3 months

DRUG

Bicalutamide

bicalutamide (Casodex) 50mg by mouth daily

DRUG

Docetaxel

Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.

PROCEDURE

Prostatectomy

Removal of the entire prostate gland, plus some surrounding tissue.

RADIATION

Radiation

5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Kenneth Pienta, MD · SKCCC at Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02716974 on ClinicalTrials.gov