Tucson, Arizona 85724

  • Radiation Toxicity

Purpose:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Amifostine may protect normal cells from the side effects of radiation therapy. PURPOSE: Phase II trial to study the effectiveness of radiation therapy plus amifostine in treating patients with primary prostate cancer.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000066254


NCT ID:

NCT00003307


Secondary ID:

P30CA023074


Study Acronym:


Brief Title:

Radiation Therapy Plus Amifostine in Treating Patients With Primary Prostate Cancer


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Arizona


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:James R. Oleson, MD, PhD
Study Chair
University of Arizona

Study Dates

Start Date:March 1998
Completion Date:June 2001
Completion Type:Actual
Primary Completion Date:June 2001
Primary Completion Type:Actual
Verification Date:May 2006
Last Changed Date:March 12, 2010
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Radiation
Name:radiation therapy
Intervention Type:Drug
Name:amifostine trihydrate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Arizona
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 01, 2021

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