Testing if radiation, hormone therapy, and docetaxel versus radiation and hormone therapy after prostectomy decreases cancer recurrence

What we are studying

The purpose of this study is to compare any good and bad effects of using docetaxel along with the radiation therapy and hormone suppression therapy to using radiation and hormone suppression therapy alone in men with a high chance of prostate cancer recurrence after surgically removing the prostate. Docetaxel is FDA-approved for prostate cancer that has spread and does not respond to hormone suppression. In this study, docetaxel is being used off-label. Off-label means that the FDA has not yet approved docetaxel for this type of prostate cancer that has not spread. The addition of docetaxel to the usual radiation and hormone suppression therapy could shrink your cancer or prevent it from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual approach. To be better, the study approach should decrease the chance of your cancer progressing by 30% or more compared to the usual approach. There will be about 612 men taking part in this study.

Who is Eligible

  • Genders:
    • Men
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • Patients post-prostatectomy with baseline Gleason ? 7 (per prostatectomy pathology)
  • Baseline PSA nadir ? 0.2 ng/ml
  • Baseline testosterone level obtained post-prostatectomy and prior to Step 1 registration
  • Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy
  • Surgical FFPE specimen must be available for submission to GenomeDx
  • Prior androgen deprivation therapy (LHRH agonist and/or non-steroidal anti-androgen) is allowed if discontinued at least 90 days prior to study enrollment and given for ? 90 days duration
  • Pathologically lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown
  • Any pT-stage based on American Joint Committee on Cancer 7th edition is eligible
  • Age ? 18
  • ECOG Performance Status of ? 1 within 60 days prior to Step 1 registration
  • Adequate hematologic function within 60 days prior to Step 1 registration
  • Adequate hepatic function within 60 days prior to Step 1 registration
  • The patient or a legally authorized representative must provide study-specific informed consent prior to Step 1 registration

What is involved

  • Pathology from radical prostatectomy
  • PSA
  • History/Physical
  • ECOG performance status
  • Testosterone
  • CBC with diff and platelets
  • AST
  • ALT
  • Total bilirubin
  • Bone scan
  • CT or MRI abdomen/pelvis
  • Decipher pathology sample available for analysis
  • Tissue for banking (for consenting patients)
  • Blood and urine for banking (for consenting patients)
  • Alkaline phosphatase
  • Adverse event evaluation
  • PSA
  • Physical exam including digital rectal exam

Compensation

None

Contact Information

Study Coordinator
Chase Thurman
Email
[email protected]
Phone
-9010

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.