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

Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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 2-10. 6 cores are strongly

- 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

- 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

- ECOG status 0-1 (appendix II) documented within 90 days of randomization.

- Patient must sign study specific informed consent prior to randomization. Note:
consent for legally authorized representative is not permitted.

- Completed all requirements listed in section 4.0 within the specified time frames.

- Able to start treatment within 56 days of randomization.

- At least 18 years old and less than or equal to 75 years of age.

- Men of child-producing potential must be willing to consent to use effective
contraception while on treatment and for at least 3 months afterwards.

- Medical oncology consultation prior to randomization and medically approved for
chemotherapy treatment per protocol.

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

- 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

- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note,
however, that HIV testing is not required for entry into this protocol. The need to
exclude patients with AIDS from this protocol is necessary because the treatments
involved in this protocol may be significantly immunosuppressive.

- Prior allergic reaction to the drugs involved in this protocol.

- Existing peripheral neuropathy grade 2.

- Prior systemic chemotherapy for prostate cancer.

- History of proximal urethral stricture requiring dilatation.

- Major medical, addictive or psychiatric illness which in the investigators
opinion,will prevent the consent process, completion of the treatment and/or
interfere with follow-up.

- Evidence of any other cancer within the past 5 years and 50% probability of a 5 year
survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous cell
cancer of the skin is allowed.)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

John Christodouleas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania


United States: Institutional Review Board

Study ID:

UPCC 22812



Start Date:

March 2013

Completion Date:

March 2018

Related Keywords:

  • Prostate Cancer
  • Men under the age of 75 with histologically confirmed high risk
  • Prostatic Neoplasms



Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283