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A Phase II Open Label Trial of Amifostine Plus Fractionated Radiotherapy for Primary Prostate Adenocarcinoma (T1a-T3b, NoMo, PSA>10 ng/ml) to Estimate Acute Grade 2 Genitourinary and Gastrointestinal Toxicity


Phase 2
18 Years
N/A
Not Enrolling
Male
Prostate Cancer, Radiation Toxicity

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Trial Information

A Phase II Open Label Trial of Amifostine Plus Fractionated Radiotherapy for Primary Prostate Adenocarcinoma (T1a-T3b, NoMo, PSA>10 ng/ml) to Estimate Acute Grade 2 Genitourinary and Gastrointestinal Toxicity


OBJECTIVES: I. Determine the incidence, grade, and time course of acute grade 2 or higher
gastrointestinal and genitourinary toxicities in patients with primary prostate
adenocarcinoma receiving amifostine plus fractionated radiotherapy. II. Determine the
incidence and nature of toxicity associated with amifostine in these patients. III. Assess
tumor response to this treatment in these patients. IV. Assess impotency rates following
radiotherapy in these patients.

OUTLINE: This is an open label study. Patients receive fractionated radiotherapy five days
per week for 7 weeks plus amifostine IV push over 5 minutes, 15 minutes before each
radiation treatment. Patients are followed at 1 month after radiotherapy, and then every 3
months for at least 5 years.

PROJECTED ACCRUAL: There will be 25 patients accrued into this study over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Stage T1a-T3b N0
M0 disease PSA at least 10 ng/mL prior to treatment Must have a risk of seminal vesicle
involvement between 10-25% No palpable or radiographic evidence of seminal vesicle
involvement

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Greater than 24 months Hematopoietic: Not specified Hepatic: SGOT and SGOT no
greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No severe cerebrovascular disease or sustained hypotension not secondary
to antihypotensive medication Other: No history of inflammatory bowel disease No history
of malignancy other than nonmelanoma skin cancer No underlying medical or psychiatric
illness that may impair ability to participate in study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the prostate area
Surgery: No prior radical prostatectomy Other: No hypertensive medications if blood
pressure less than 120/70

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James R. Oleson, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Arizona

Authority:

United States: Federal Government

Study ID:

CDR0000066254

NCT ID:

NCT00003307

Start Date:

March 1998

Completion Date:

June 2001

Related Keywords:

  • Prostate Cancer
  • Radiation Toxicity
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • radiation toxicity
  • Adenocarcinoma
  • Prostatic Neoplasms
  • Radiation Injuries

Name

Location

Arizona Cancer CenterTucson, Arizona  85724