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A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation


Phase 3
N/A
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Freedom from biochemical and/or disease failure rates

Safety Issue:

No

Principal Investigator

Mark Buyyounouski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000304712

NCT ID:

NCT00062309

Start Date:

June 2002

Completion Date:

Related Keywords:

  • Prostate Cancer
  • stage II prostate cancer
  • stage III prostate cancer
  • adenocarcinoma of the prostate
  • Prostatic Neoplasms

Name

Location

Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497