NCT00040365

Brief Summary

This study will evaluate the safety and effectiveness of a drug called amifostine in reducing the bowel side effects of radiation treatment for prostate cancer. Amifostine is a 'radioprotector' medicine that to protects normal tissue from radiation damage. This study will determine whether placing amifostine in the rectum during radiation treatment for prostate cancer can decrease common side effects of treatment, including diarrhea, painful bowel movements, bleeding, and gas. Patients 18 years of age or older with prostate cancer may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, bone scan if a recent one is not available, and possibly computed tomography (CT) and magnetic resonance imaging (MRI) scans of the pelvis. They will also have a liquid retention test, in which they are given an enema of 4 tablespoons of salt water that they must retain for 20 minutes. Participants will receive standard radiation therapy for prostate cancer-5 consecutive days for 8 weeks-in the National Institutes of Health (NIH) Radiation Oncology Clinic. Amifostine will be placed in the rectum by a mini-enema before each radiation treatment so that it covers the lining of the rectum. To determine the side effects of the treatment, patients will undergo a proctoscopic examination before beginning radiation therapy, two times during therapy, and at each follow-up visit for 5 years after treatment ends. This examination involves inserting a proctoscope (a thin flexible tube with a light at the end) into the rectum and taking pictures. Patients will be followed in the clinic at visits scheduled 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment for a physical examination and routine blood tests, proctoscopic examination, and review of bowel symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2002

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 29, 2012

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

7.9 years

First QC Date

June 25, 2002

Results QC Date

January 13, 2012

Last Update Submit

April 26, 2012

Conditions

Prostatic Neoplasms

Keywords

Prostate CancerRadiation TherapyRectal ToxicityAmifostineRadioprotector

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With a Good Toxicity Outcome Who Experienced an Acute Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.

    A good toxicity outcome is defined as having less than grade 2 on both weeks 5 and 7 of treatment. The Radiation Therapy Oncology Group (RTOG) Acute radiation morbidity scoring scheme and the Rectal Mucosal Toxicity response criteria will be used to assess rectal toxicity. The RTOG measures the rectal toxicities. The physician assigns a grade based on symptoms reported by the patient. For details about the RTOG (method and scoring of radiation morbidity, etc.) see http://www.rtog.org/ResearchAssociates/AdverseEventReporting/AcuteRadiationMorbidityScoringCriteria.aspx

    RTOG Acute was used on week 5 and 7

Secondary Outcomes (5)

  • Percentage of Participants With a Good Toxicity Outcome Who Experienced Late Rectal Toxicity and Received Topical Administrations of Amifostine in Conjunction With High Dose, 3D Conformal Radiotherapy for Prostate Cancer.

    The late rectal toxicity has been assessed at 1, 3, 6, 12, 18, 24, 36, and 60 months after the completion of treatment.

  • Number of Participants With Adverse Events

    3 years

  • Expanded Prostate Cancer Index Composite (EPIC) Bowel Assessment Over Time (Late Follow-up 18 Months)

    18 months

  • Measures of Quality of Life (QOL)-(Late Follow-up 18 Months)

    Baseline, week 5, 7 , and months 1, 3, 6, 12, and 18

  • Number of Participants Who Had Proctoscopic Examinations

    3 years

Study Arms (1)

Amifostine

EXPERIMENTAL

1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).

Drug: Amifostine trihydrateRadiation: Radiation therapy

Interventions

Amifostine trihydrateDRUG

1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).

Also known as: Ethyol
Amifostine
Radiation therapyRADIATION

The treatment will be delivered in at least two phases. The first field reduction will occur after 46Gy and the second field reduction will occur after 70Gy.

Also known as: radiotherapy, irradiation, x-ray therapy
Amifostine

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed adenocarcinoma of the prostate gland.
  • Age greater than or equal to 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed (this does not include routine laboratory tests or imaging studies required to establish eligibility).

You may not qualify if:

  • Other active malignancy (except for non-melanoma skin cancer).
  • Patient with a prior history of pelvic or prostate radiotherapy.
  • Patients with chronic inflammatory bowel disease.
  • Patients with distant metastatic disease.
  • Cognitively impaired patients who cannot give informed consent.
  • Human Immunodeficiency Virus (HIV) positivity.
  • Other medical conditions deemed by the principal investigator (PI) or associates to make the patient ineligible for high dose radiotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (9)

  • Greenlee RT, Hill-Harmon MB, Murray T, Thun M. Cancer statistics, 2001. CA Cancer J Clin. 2001 Jan-Feb;51(1):15-36. doi: 10.3322/canjclin.51.1.15.

    PMID: 11577478BACKGROUND

  • Fuks Z, Leibel SA, Wallner KE, Begg CB, Fair WR, Anderson LL, Hilaris BS, Whitmore WF. The effect of local control on metastatic dissemination in carcinoma of the prostate: long-term results in patients treated with 125I implantation. Int J Radiat Oncol Biol Phys. 1991 Aug;21(3):537-47. doi: 10.1016/0360-3016(91)90668-t.

    PMID: 1869452BACKGROUND

  • Pollack A, Smith LG, von Eschenbach AC. External beam radiotherapy dose response characteristics of 1127 men with prostate cancer treated in the PSA era. Int J Radiat Oncol Biol Phys. 2000 Sep 1;48(2):507-12. doi: 10.1016/s0360-3016(00)00620-9.

    PMID: 10974469BACKGROUND

  • Simone NL, Menard C, Soule BP, Albert PS, Guion P, Smith S, Godette D, Crouse NS, Sciuto LC, Cooley-Zgela T, Camphausen K, Coleman CN, Singh AK. Intrarectal amifostine during external beam radiation therapy for prostate cancer produces significant improvements in Quality of Life measured by EPIC score. Int J Radiat Oncol Biol Phys. 2008 Jan 1;70(1):90-5. doi: 10.1016/j.ijrobp.2007.05.057. Epub 2007 Sep 12.

    PMID: 17855015RESULT

  • Simone, NL; Soule, BP; Ménard, C; Albert, P; Guion, P; Smith, S; Godette, D; Coleman, CN; Singh, AK. Assessing Rectal Toxicity in a Pilot Study using Intrarectal Amifostine and Concurrent Radiation. 42nd annual meeting of the American society of clinical oncology, Atlanta, GA, June 2006.

    RESULT

  • Menard C, Camphausen K, Muanza T, Sears-Crouse N, Smith S, Ben-Josef E, Coleman CN. Clinical trial of endorectal amifostine for radioprotection in patients with prostate cancer: rationale and early results. Semin Oncol. 2003 Dec;30(6 Suppl 18):63-7. doi: 10.1053/j.seminoncol.2003.11.016.

    PMID: 14727242RESULT

  • Singh AK, Menard C, Guion P, Simone NL, Smith S, Crouse NS, Godette DJ, Cooley-Zgela T, Sciuto LC, Coleman J, Pinto P, Albert PS, Camphausen K, Coleman CN. Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: a pilot study. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1008-13. doi: 10.1016/j.ijrobp.2006.02.030. Epub 2006 May 26.

    PMID: 16730138RESULT

  • Simone NL, Ménard C, Singh AK, Guion P, Smith S, Crouse NS, Godette D, Cooley-Zgela T, Sciuto LC, Coleman J, Pinto, P, Albert PS, Camphausen K, Coleman CN. Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: oral presentation at 91st scientific assembly and annual meeting of the radiological society of North America, Chicago, IL, 2005.

    RESULT

  • Muanza TM, Albert PS, Smith S, Godette D, Crouse NS, Cooley-Zgela T, Sciuto L, Camphausen K, Coleman CN, Menard C. Comparing measures of acute bowel toxicity in patients with prostate cancer treated with external beam radiation therapy. Int J Radiat Oncol Biol Phys. 2005 Aug 1;62(5):1316-21. doi: 10.1016/j.ijrobp.2004.12.083.

    PMID: 16029787RESULT

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

AmifostineRadiotherapyRadiationX-Ray Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsTherapeuticsPhysical Phenomena

Results Point of Contact

Title
Kevin A. Camphausen
Organization
National Cancer Institute (NCI), National Institutes of Health (NIH)
camphauk@mail.nih.gov
301-496-5457

Study Officials

  • Kevin A camphausen, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

June 25, 2002

First Posted

June 26, 2002

Study Start

June 1, 2002

Primary Completion

May 1, 2010

Study Completion

June 1, 2011

Last Updated

April 30, 2012

Results First Posted

March 29, 2012

Record last verified: 2012-04

Locations

US(1)