Intensity-Modulated Radiation Therapy With or Without Decreased Radiation Dose to Erectile Tissue in Treating Patients With Stage II Prostate Cancer

NCT ID: NCT00084552

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-11
• Study Completion Date: 2016-05-05

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction.

PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer.

Detailed Description

OBJECTIVES:

Primary

• Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the prostate after treatment with intensity-modulated radiotherapy with vs without dose sparing for erectile tissue.

Secondary

• Compare biochemical freedom from failure rates, as a measure of prostate cancer control, in patients treated with these regimens.
• Compare the quality of life of patients treated with these regimens.
• Determine the association of molecular markers and biochemical freedom from failure rate and other endpoints in patients treated with these regimens.

OUTLINE: This is a randomized, single-blind study. Patients are stratified according to age (≤ 65 vs > 65), prescription radiotherapy dose (74 Gy vs 76 Gy), and frequency of erection during sexual activity within the past 4 weeks (a few times vs sometimes vs most times to always). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
• Arm II: Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.

Treatment in both arms continues in the absence of unacceptable toxicity or disease metastasis.

Quality of life is assessed at baseline, at 6 and 12 months, and then annually for 4 years

Patients are followed at 3 months and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this study within 2.5 years.

Conditions

Prostate Cancer; Sexual Dysfunction; Sexuality and Reproductive Issues

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm I

Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

Group Type: ACTIVE_COMPARATOR

radiation therapy

Intervention Type: RADIATION

Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

Arm II

Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.

Group Type: EXPERIMENTAL

radiation therapy

Intervention Type: RADIATION

Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

Interventions

radiation therapy

Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

• Clinical stage T1b-T2c by palpation
• Pretreatment prostate-specific antigen ≤ 20 ng/mL
• Gleason score ≤ 7
• Suitable erectile function, defined as a response ≥ score 2 in question #1 of the International Index of Erectile Function Questionnaire
• No clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease

PATIENT CHARACTERISTICS:

Age

• Not specified

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Fertile patients must use effective contraception
• No other active malignancy within the past 5 years except nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma)
• No other medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Prior androgen-ablation therapy allowed provided total calculated duration ≤ 4 months

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

Sponsors

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Horwitz, MD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CDR0000365458

Identifier Type: -

Identifier Source: secondary_id

03-028

Identifier Type: -

Identifier Source: org_study_id