NCT00667888

Brief Summary

The goal of this clinical research study is to compare using external beam radiotherapy with intensity modulated beams for fewer days at a higher dose per day to the same type of therapy for more days at a lower dose per day in the treatment of prostate cancer. The safety of these treatments will also be studied and compared.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P25-P50 for phase_3 prostate-cancer

Timeline
Completed

Started Jan 2001

Longer than P75 for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

January 3, 2001

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2008

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2015

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

January 25, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

14.8 years

First QC Date

April 24, 2008

Results QC Date

January 4, 2021

Last Update Submit

January 4, 2021

Conditions

Prostate Cancer

Keywords

Prostate CancerRadiationRadiotherapyIntensity Modulated RadiotherapyIMRTHypofractionated Intensity Modulated RadiotherapyHIMRT

Outcome Measures

Primary Outcomes (1)

  • Conventional Radiotherapy (CIMRT) Versus Hypofractionated Radiotherapy (HIMRT)

    To determine the progression of the number of participants who failed treatment after receiving (CIMRT) versus (HIMRT). PSA measured on (CIMRT) and (HIMRT) for each participant on both arms. Failure was defined as Prostate-specific antigen (PSA) failure using the Phoenix definition of nadir plus 2 ng/ml, or initiation of salvage therapy.

    8.5 years

Study Arms (2)

Intensity Modulated Radiotherapy (IMRT)

ACTIVE COMPARATOR

A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).

Radiation: Conventional Fractionated Intensity Modulated Radiotherapy

Hypofractionated Intensity Modulated Radiotherapy (HIMRT)

EXPERIMENTAL

A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Radiation: Hypofractionated Intensity Modulated Radiotherapy

Interventions

Conventional Fractionated Intensity Modulated RadiotherapyRADIATION

A total dose of 75.6 Gy will be delivered in 42 fractions to the planning target volume (PTV).

Also known as: IMRT
Intensity Modulated Radiotherapy (IMRT)
Hypofractionated Intensity Modulated RadiotherapyRADIATION

A total dose of 72 Gy will be delivered in 30 fractions to the PTV.

Also known as: HIMRT
Hypofractionated Intensity Modulated Radiotherapy (HIMRT)

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proof of adenocarcinoma of the prostate.
  • Bone scan (If PSA \>10 ng/ml or T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
  • CT-scan of pelvis (If Stage T3 disease) within 3 months of starting androgen ablation or signing protocol consent if no androgen ablation.
  • Suitable medical condition; Zubrod \<2.
  • Pretreatment PSA \</=20 ng/ml. If PSA \<4, must have Gleason greater than or equal to 7 and/or Stage T2b-T2c. PSA within 30 days of signing protocol consent. If neoadjuvant androgen ablation has been given, then the preandrogen ablation PSA should be used for stratification.
  • Clinical (palpable) Stage T1b - T3b disease (1992 AJCC staging system).
  • While a transrectal ultrasound will be obtained before treatment, the staging will not be based on these findings. If palpable T3 disease is present, then must have Gleason score \<8 and pretreatment PSA less than or equal to 10 ng/ml
  • Gleason score \<10.
  • If Gleason score 8 or 9, then must have stage T1/T2 disease and pretreatment PSA less than or equal to 10 ng/ml.
  • The patient must be able to understand the protocol and adhere to follow-up at 6-month intervals for the first 2 years and at yearly intervals thereafter.
  • Informed consent must be given.
  • Patients randomized to Arm 1 may also participate in protocol 2004-0428.

You may not qualify if:

  • Prior pelvic radiotherapy.
  • Greater than 4 months of prior hormone ablation therapy.
  • Prior or planned radical prostate surgery.
  • Clinical, radiographic or pathologic evidence of nodal or distant metastatic disease.
  • Concurrent, active malignancy, other than nonmetastatic skin cancer or early stage -chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for greater than or equal to 5 yr then the patient is eligible.
  • Zubrod status greater than or equal to 2.
  • Pretreatment PSA \>20 ng/ml.
  • Gleason score of 10.
  • Palpable stage T3c (seminal vesicle involvement) or T4 disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Hassanzadeh C, Kuban D, Pasyar S, Bassett R, Troncoso P, Ansari M, Schlembach P, McGuire S, Nguyen Q, Frank S, Mok H, Mohamad O, Park R, Tang C, Du W, Kudchadker R, Choi S, Hoffman K. Hypofractionated, Dose-Escalated Radiation Versus Conventionally Fractionated Radiation for Localized Prostate Cancer: Long-Term Update of a Phase III, Prospective, Randomized Controlled Trial. J Clin Oncol. 2025 Jun 20;43(18):2044-2048. doi: 10.1200/JCO-24-02057. Epub 2025 May 14.

    PMID: 40367400DERIVED

  • Kim S, Kong JH, Lee Y, Lee JY, Kang TW, Kong TH, Kim MH, You SH. Dose-escalated radiotherapy for clinically localized and locally advanced prostate cancer. Cochrane Database Syst Rev. 2023 Mar 8;3(3):CD012817. doi: 10.1002/14651858.CD012817.pub2.

    PMID: 36884035DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Karen Huffman, MD/ Associate Professor, Radiation Oncology Department
Organization
UT MD Anderson Cancer Center
khoffman1@mdanderson.org
(713) 563-2339

Study Officials

  • Deborah A. Kuban, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

April 24, 2008

First Posted

April 28, 2008

Study Start

January 3, 2001

Primary Completion

October 12, 2015

Study Completion

October 1, 2021

Last Updated

January 25, 2021

Results First Posted

January 25, 2021

Record last verified: 2021-01

Locations

US(1)