Know Cancer

forgot password

A Phase I/II Trial of Post-Prostatectomy Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3NO Prostate Cancer

Phase 1/Phase 2
18 Years
85 Years
Open (Enrolling)
Prostate Cancer

Thank you

Trial Information

A Phase I/II Trial of Post-Prostatectomy Radiation Therapy, Hormonal Therapy and Concurrent Docetaxel for High Risk Pathologic T2-T3NO Prostate Cancer

To determine the safety and feasibility of combining post-operative radiation therapy, and
hormonal therapy (6 months) and concurrent docetaxel in men with high risk pathologic T2-3N0
prostate cancer after a radical prostatectomy.

To obtain preliminary information regarding the efficacy of combining weekly docetaxel with
adjuvant radiation therapy and hormonal therapy in men with high risk pathologic T2-3N0
prostate cancer by determining PSA failure free survival.

To assess baseline and longitudinal changes in health-related quality of life outcomes
during and after therapy (at 3, 6, 12 and 24 months)

Inclusion Criteria:

- 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 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

- 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:

1. Pathologic T2N0 disease with positive margins and Gleason score ≥8, or

2. Pathologic T3aN0disease with extracapsular extension and Gleason Score ≥ 8,

3. Pathologic T3bN0disease 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:

1. Pathologic T3bN0 disease with any Gleason score, or

2. Pathologic T2-3aN0 disease with Gleason score ≥ 8,

3. Pathologic T2-3aN0 disease with PSA doubling time ≤10 months, or

4. 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:

- 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

- > 5x ULN - ineligible

- AST or ALT

- ≤ ULN - eligible

- > 1x but ≤1.5x ULN - eligible

- > 2.5x but ≤ 5x ULN - ineligible

- > 5x ULN - ineligible

- Patients with a history of an invasive malignancy within the last 5 years are not
eligible for the protocol; patients who are NED from a prior invasive malignancy for
at least 5 years or longer are eligible for the trial. Patients with history of
benign tumors such as a pituitary macroadenomas, meningiomas, or craniopharyngiomas
are eligible as long as the benign tumor is under local control regardless of the
time frame. Patients with concurrent adequately treated basal cell or squamous cell
carcinoma of the skin are also eligible for the protocol.

- Patients must be informed of the investigative nature of the treatment, must give
appropriate informed consent to protocol procedures and must sign an Informed Consent
Documentation Form.

- Must not have concomitant medical, psychological or social circumstances which would
interfere with compliance with the protocol treatment and follow-up.

- Age ≥ 18 years

- Men of childbearing potential must be willing to consent to using effective
contraception while on treatment and for a reasonable period thereafter, which should
be for at least 6 months after the completion of protocol therapy

Exclusion Criteria:

- 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

- Pre-existing Grade ≥ 1 peripheral neuropathy

- Patients with a history of a hypersensitivity reaction to products containing
Polysorbate 80 (Tween 80)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine whether greater than or equal to 95% of patients who undergo adjuvant hormonal therapy, radiation therapy and docetaxel after a radical prostatectomy can safely tolerate and complete this regimen.

Outcome Time Frame:

Approximately 6-8 mos.

Safety Issue:


Principal Investigator

Parvesh Kumar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Institutional Review Board

Study ID:




Start Date:

August 2012

Completion Date:

September 2014

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms



University of Kansas Medical Center Kansas City, Kansas  66160-7353