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CompletedNCT00062309Updated Mar 3, 2016

Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer

A Phase 3 interventional study of radiation therapy in Prostate Cancer, sponsored by Fox Chase Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-03.

Sponsored by Fox Chase Cancer Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
307
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of conventional intensity-modulated radiotherapy (IMRT) vs hypofractionated IMRT, in terms of freedom from biochemical failure in men with intermediate- to high-risk prostate cancer.
  • Compare the local control, freedom from distant metastasis, and overall survival of patients treated with these regimens.
  • Determine local failure, using biopsy of the prostate, when objective tests (prostate-specific antigen, ultrasound, and digital rectal exam) suggest relapse in these patients.
  • Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Determine the impact of these regimens on patient preferences and utilities.

OUTLINE: This is a randomized study. Patients are stratified according to pretreatment prostate-specific antigen (no greater than 10 ng/mL vs greater than 10 to 20 ng/mL vs greater than 20 ng/mL), Gleason score (5-7 vs 8-10), and risk status (high risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) 5 days a week for 7.5 weeks in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.

Patients with high-risk disease also undergo androgen deprivation therapy for 2 years.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 4 years.

Patients are followed at 3 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • stage II prostate cancer
  • stage III prostate cancer
  • adenocarcinoma of the prostate
03

In context

Prostatic Neoplasms

6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.

This study's enrollment of 307 is above the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Fox Chase Cancer Center is the lead sponsor of 215 studies on the registry; 30 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Browse Fox Chase Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
307 participants (actual)

Study arms

  • Active comparator
    CIMRT

    76 Gy in 38 fractions

    Radiation: radiation therapy

  • Experimental
    HIMRT

    70.2 Gy in 26 fractions

    Radiation: radiation therapy

Interventions

  • Radiationradiation therapy
06

What researchers measure

Primary outcomes

  1. Freedom from biochemical and/or disease failure rates

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

07

Study locations

1 site
  • Fox Chase Cancer Center - Philadelphia
    Philadelphia, Pennsylvania 19111-2497, United States
08

References and documents

Publications

  • 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.
  • 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. PubMed 32119599 ↗
  • 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. PubMed 24101042 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2002 and a primary completion of May 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 5, 2003
First posted
Jun 6, 2003
Start
Jun 2002
Primary completionActual
May 2006
Last update
Mar 3, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00062309
Lead sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 6, 2003
Start date
Jun 2002
Primary completion
May 2006
Last update
Mar 3, 2016

Study contacts

Mark Buyyounouski, MD
principal investigator · Fox Chase Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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