Postoperative Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

Following a radical prostatectomy and lymph node sampling, eligible patients will undergo post-operative radiation therapy, concurrent weekly docetaxel chemotherapy , and hormonal therapy (Casodex daily and Zoladex every 3 months for 2 times or Lupron 22.5 mg im every 3 months for 2 times).

Key facts

Study ID

NCT00669162

Run by

University of Kansas Medical Center

People needed

27

Starts

2012-08-01

Expected to finish

2017-04-01

Last updated by the study team

2019-07-24

Who can join

Age: 18 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Only those patients with adenocarcinoma of the prostate who have undergone a radical prostatectomy with pelvic lymph node sampling and found to have high risk non-metastatic disease with undetectable, persistent or decreasing post-operative Prostate Specific Antigen (PSA) levels, or who have subsequently experienced a rise in PSA, will be eligible for the trial as described below in the inclusion and exclusion criteria
• Histologically documented adenocarcinoma of the prostate.
• Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with the patients falling into either the "adjuvant high risk group" or the "salvage high risk group" as follows:
• a) "Adjuvant High Risk Group" (undetectable, persistent or decreasing PSA levels before starting therapy) who have NO evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence) who MUST be able to start RT treatments within 6 months of radical prostatectomy with at least one of the 3 disease features:
• Pathologic tumor 2-node 0 (T2N0) disease with positive margins and Gleason score ≥8, or
• Pathologic tumor 3a-node 0 T3aN0 disease with extracapsular extension and Gleason Score ≥ 8, or
• Pathologic tumor 3b-node 0 T3bN0 disease with any Gleason Score
• b) "Salvage High Risk Group" are those patients with PSA biochemical failure defined by 2 consecutive increases over baseline PSA levels at least one month apart, who have NO other evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence), and WITH AT LEAST ONE of the high risk disease features as defined below:
• Pathologic T3bN0 disease with any Gleason score, or
• Pathologic T2-3aN0 disease with Gleason score ≥ 8,
• Pathologic T2-3aN0 disease with PSA doubling time ≤10 months, or
• Pathologic T2-3aN0 disease with Pre-radiation therapy PSA level ≥1.0 ng/ml
• Neoadjuvant hormonal therapy prior to radical prostatectomy is allowed, and post-prostatectomy hormonal therapy is allowed as long as it is not within 6 months of protocol treatment
• No prior chemotherapy, or pelvic irradiation
• Karnofsky Performance Status ≥70
• Hematologic parameters must be within the following limits:
• white blood cell count (WBC) ≥ 3,000
• Platelet Count ≥ 130,000/ mm3
• Hemoglobin level ≥ 11.0 g/dl
• Creatinine ≤ 2.5 g/dl
• Normal liver function defined as the following: Total bilirubin below the upper limit of normal AND AST, ALT, and Alkaline Phosphatase must be within a defined range of eligibility as noted below:
• Alkaline Phosphatase
• ≤ ULN - eligible
• > 1x but ≤1.5x ULN - eligible
• > 2.5x but ≤ 5x ULN - eligible

You may not qualify if…

• Patients who have received prior chemotherapy, pelvic irradiation or post-prostatectomy androgen ablation within 6 months of protocol therapy.
• Any coexisting medical condition precluding full compliance with the study.
• Patients with active infections or known infection with HIV.
• Psychological, familiar, sociological or geographical conditions which would not permit compliance with the study protocol.
• Known contraindication to dexamethasone (allergic reaction or systemic fungal infection)
• Pre-existing Grade ≥ 1 peripheral neuropathy
• Patients with a history of a hypersensitivity reaction to products containing Polysorbate 80 (Tween 80)

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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