Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Steven N. Seyedin

Description

Summary

This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.

Official Title

Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging Into Salvage Treatment for Patients With Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE*) *INtensifying Treatment for NOde Positive Prostate Cancer by VArying the Hormonal ThErapy

Details

Keywords

Prostate Adenocarcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Prostatic Neoplasms, Hormones, Apalutamide, Hormone Therapy, Quality-of-Life Assessment, Radiation Therapy, hormone therapy, radiation therapy, hormone therapy, radiation therapy, apalutamide

Eligibility

Locations

  • UCSF Medical Center-Mount Zion accepting new patients
    San Francisco California 94115 United States
  • UCSF Medical Center-Parnassus accepting new patients
    San Francisco California 94143 United States
  • UCSF Medical Center-Mission Bay accepting new patients
    San Francisco California 94158 United States
  • Marin General Hospital accepting new patients
    Greenbrae California 94904 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
NRG Oncology
ID
NCT04134260
Phase
Phase 3 Prostate Cancer Research Study
Study Type
Interventional
Participants
Expecting 586 study participants
Last Updated