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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Hypo-fractionated Proton Radiation for Low Risk Prostate Cancer

NCT01230866

Prostate Cancer

ACTIVE_NOT_RECRUITING PHASE3

High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer

NCT01655836

Prostate Cancer Adenocarcinoma of the Prostate Recurrent Prostate Cancer +2 more

ACTIVE_NOT_RECRUITING PHASE1

Hypofractionated Radiation Therapy for Treating Prostate Cancer High-Risk Features Following Radical Prostatectomy

NCT03570827

Prostate Adenocarcinoma Stage IIB Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8 +3 more

COMPLETED PHASE2

Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

NCT00769548

Prostate Cancer

COMPLETED PHASE3

Phase II High Dose Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

NCT02960087

Prostate Carcinoma

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CIMRT

76 Gy in 38 fractions

Group Type ACTIVE_COMPARATOR

radiation therapy

Intervention Type RADIATION

HIMRT

70.2 Gy in 26 fractions

Group Type EXPERIMENTAL

radiation therapy

Intervention Type RADIATION

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No