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


Phase 3
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer, Sexual Dysfunction, Sexuality and Reproductive Issues

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Trial Information

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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Erectile dysfunction rates as measured by IIEF after treatment

Outcome Time Frame:

6 month intervals after completion of radiotherapy for 5 years

Safety Issue:

No

Principal Investigator

Eric Horwitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000365458

NCT ID:

NCT00084552

Start Date:

December 2003

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Sexual Dysfunction
  • Sexuality and Reproductive Issues
  • sexual dysfunction
  • sexuality and reproductive issues
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Prostatic Neoplasms
  • Sexual Dysfunctions, Psychological

Name

Location

Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497