NCT00062309

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
307

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

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
1 year until next milestone

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

3.9 years

First QC Date

June 5, 2003

Last Update Submit

March 1, 2016

Conditions

Prostate Cancer

Keywords

stage II prostate cancerstage III prostate canceradenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

  • Freedom from biochemical and/or disease failure rates

    weekly during treatment, at 3 months, 6 months or 2 years then yearly

Study Arms (2)

CIMRT

ACTIVE COMPARATOR

76 Gy in 38 fractions

Radiation: radiation therapy

HIMRT

EXPERIMENTAL

70.2 Gy in 26 fractions

Radiation: radiation therapy

Interventions

radiation therapyRADIATION
CIMRTHIMRT

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the prostate * Clinical stage T1b-T3c disease * No clinical or radiographic evidence of metastasis * Prostate-specific antigen (PSA) less than 80 ng/mL * Gleason score at least 5 * One of the following criteria must be met: * PSA greater than 10 ng/mL * Gleason score greater than 6 * T2b or greater palpable disease * Three or more biopsy cores involved with a Gleason score of at least 5 PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No other medical condition that would preclude study participation * No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia) * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * No more than 4 months of prior androgen deprivation therapy * Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only Radiotherapy * No prior pelvic radiotherapy Surgery * No prior or planned radical prostate surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (3)

  • Pollack A, Bae K, Khor LY, et al.: Stability of tumor biomarkers in archival tissue from men treated with radiotherapy for prostate cancer: an analysis of RTOG 92-02 and Fox Chase randomized trials. [Abstract] Int J Biol Markers 22 (1): 72-3, 2006.

    BACKGROUND

  • Avkshtol V, Ruth KJ, Ross EA, Hallman MA, Greenberg RE, Price RA Jr, Leachman B, Uzzo RG, Ma C, Chen D, Geynisman DM, Sobczak ML, Zhang E, Wong JK, Pollack A, Horwitz EM. Ten-Year Update of a Randomized, Prospective Trial of Conventional Fractionated Versus Moderate Hypofractionated Radiation Therapy for Localized Prostate Cancer. J Clin Oncol. 2020 May 20;38(15):1676-1684. doi: 10.1200/JCO.19.01485. Epub 2020 Mar 2.

    PMID: 32119599DERIVED

  • Pollack A, Walker G, Horwitz EM, Price R, Feigenberg S, Konski AA, Stoyanova R, Movsas B, Greenberg RE, Uzzo RG, Ma C, Buyyounouski MK. Randomized trial of hypofractionated external-beam radiotherapy for prostate cancer. J Clin Oncol. 2013 Nov 1;31(31):3860-8. doi: 10.1200/JCO.2013.51.1972. Epub 2013 Oct 7.

    PMID: 24101042DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Mark Buyyounouski, MD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

June 1, 2002

Primary Completion

May 1, 2006

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations

US(1)