NCT02716974

A Study of Definitive Therapy to Treat Prostate Cancer

A Phase II Study of Definitive Therapy for Newly Diagnosed Men With Oligometastatic Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Neoadjuvant treatment (month 1 through \~6): All patients will be treated with up to 6 months of androgen deprivation, plus up to 6 cycles of docetaxel chemotherapy. Following docetaxel therapy, patients with a prostate-specific antigen response of at least a 50% decrease from baseline, will proceed to maximum consolidative therapy. Surgery and Radiation (month 7 though \~11): After completion of neoadjuvant therapy, the men will be treated with definitive local therapy with radical prostatectomy (RP) +/- adjuvant radiation therapy (RT). After definitive local therapy, patients will be treated with consolidative stereotactic body radiation therapy (SBRT) to the metastatic sites. Follow up: Patients will continue on androgen deprivation for a total of 1 year. They will be followed clinically and monitored with serum testosterone and prostate-specific antigen until 2-years after completion of ADT (Androgen deprivation therapy) treatment. Androgen blockade will be the same throughout the course of treatment.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2016-03-23
• Last updated: 2022-08-04
• Results posted: 2022-08-04

Locations

3 sites across 1 country: United States