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

Abramson Cancer Center at Penn Medicine1 site in 1 countryMarch 2013

ConditionsProstate Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: Abramson Cancer Center at Penn Medicine
Locations: 1
Primary Endpoint: Number of Adverse Events
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

April 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed prostate adenocarcinoma (within 365 days of randomization).
•High-risk for recurrence as determined by evidence of at least one of the following: Gleason Score 8-10 PSA 20 T stage T3
•Histological evaluation of prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason score must be in the range 2-
•6 cores are strongly recommended.
•Clinical stages T1a- T3 N0 M0 as staged by the treating investigator. (AJCC Criteria 7th Ed.-appendix III).
•PSA values 50 ng/ml within 90 days prior to randomization. Must be completed prior to biopsy or at least 21 days after prostate biopsy.
•Absolute Neutrophil Count (ANC) 1,800 cells/mm³ within 90 days prior to randomization.
•Platelets 100,000 cells/mm³ within 90 days prior to randomization.
•Hemoglobin 10 g/dl within 90 days prior to randomization. 3.1.9 ALT, AST, and total bilirubin within 1.5 X institutional upper normal limits within 90 days prior to randomization.
•ECOG status 0-1 (appendix II) documented within 90 days of randomization.

Exclusion Criteria

•Evidence of distant metastasis.
•Pelvic lymph nodes 1.5 cm in greatest dimension unless the enlarged lymph node is biopsied and negative.
•Prior prostate cancer surgery including but not limited to prostatectomy, hyperthermia and cryosurgery.
•Prior pelvic radiation for their prostate cancer.
•Prior androgen suppression.
•Severe, active co-morbidity, defined as follows:
•Active rectal diverticulitis, Crohns disease affecting the rectum or ulcerative colitis. (Non-active diverticulitis and Crohns disease not affecting the rectum are allowed).
•Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months.
•Myocardial infarction within the last 6 months.
•Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization.