NCT01811810

Proton Therapy for High Risk Prostate Cancer

Phase 2/3 Study of Dose-escalated External Beam Radiation Therapy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The most common treatment for men with high risk prostate cancer is radiation therapy (XRT) followed by long term androgen deprivation therapy (ADT). Long-term AD is toxic, with substantial metabolic, physical, mental and sexual side-effects. In this study, the investigators propose a treatment strategy to optimize the control of high risk prostate cancer by using dose-escalated external beam radiation (proton therapy or IMRT) concurrent with docetaxel and adjuvant short-course AD. The investigators hypothesize that this approach will be superior to the current standard of care and obviate the need for long term AD. In this study, subjects will be randomized to either XRT with long term ADT or XRT and chemotherapy and short term ADT.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Radiation therapy (XRT)
OTHER	Androgen Deprivation Therapy (ADT)
OTHER	Chemotherapy

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2013-03-15
• Last updated: 2019-04-23

Locations

1 site across 1 country: United States