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

NCT00084552 | Completed Results

• 2 other identifiers: 03-028CDR0000365458
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Sexual Dysfunction; Sexuality and Reproductive Issues

Keywords

sexual dysfunction; sexuality and reproductive issues; adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

• Erectile Dysfunction Rates

  Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire * 15-item questionnaire that measures erectile function * Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy

  5 year duration after completion of radiotherapy

Secondary Outcomes (3)

• Percentage of Patients With Freedom From Biochemical Failure

  2 years after treatment

• Acute GI Toxicity

  5 years after treatment

• Acute GU Toxicity

  5 years after treatment

Study Arms (2)

Arm I

ACTIVE COMPARATOR

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

Radiation: radiation therapy

Arm II

EXPERIMENTAL

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

Radiation: radiation therapy

Interventions

radiation therapy RADIATION

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

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Sexual Dysfunction, Physiological; Sexuality

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

The magnitude of the effect of erectile sparing constraints may be decreased for patients who experience dose-limiting parameters in the s-IMRT arm. Some patients did not complete follow-up, and to submit follow-up questionnaires at 24 months post-treatment.

Results Point of Contact

• Title: Eric Horwitz
• Organization: Fox Chase Cancer Center

Eric.Horwitz@fccc.edu

215-728-2995

Study Officials

• Eric Horwitz, MD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: December 11, 2003
• Primary Completion: August 24, 2013
• Study Completion: May 5, 2016
• Last Updated: February 25, 2021
• Results First Posted: February 25, 2021

Record last verified: 2021-02

Locations

US (1)