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



Status:Active, not recruiting
Conditions:Prostate Cancer, Cancer, Psychiatric, Women's Studies
Therapuetic Areas:Oncology, Psychiatry / Psychology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2003

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Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer

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.

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.

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
We found this trial at
1
site
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
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