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A PROSPECTIVE MULTICENTER RANDOMIZED STUDY COMPARING STRONTIUM-89 CHLORIDE AND PALLIATIVE LOCAL FIELD RADIOTHERAPY IN PATIENTS WITH HORMONAL ESCAPED ADVANCED PROSTATIC CANCER


Phase 3
N/A
N/A
Not Enrolling
Male
Metastatic Cancer, Prostate Cancer

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Trial Information

A PROSPECTIVE MULTICENTER RANDOMIZED STUDY COMPARING STRONTIUM-89 CHLORIDE AND PALLIATIVE LOCAL FIELD RADIOTHERAPY IN PATIENTS WITH HORMONAL ESCAPED ADVANCED PROSTATIC CANCER


OBJECTIVES: I. Compare, in a randomized Phase III setting, the subjective response rate,
time to progression, and survival of patients with hormone-refractory prostate cancer with
painful osseous metastases treated with either strontium-89 or palliative local
radiotherapy. II. Compare the quality of life achieved on these two regimens. III. Determine
the toxicity and morbidity of treatment on these two regimens. IV. Compare the cost
effectiveness of these two regimens.

OUTLINE: Randomized study. Arm I: Radioisotope therapy. Strontium-89 chloride, Strontium-89.
Arm II: Radiotherapy. Involved-field irradiation (equipment unspecified).

PROJECTED ACCRUAL: 200 patients will be entered over 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven carcinoma of the prostate
that has relapsed subsequent to chemical or surgical castration and/or antiandrogen
therapy Painful, unirradiated osseous metastasis required Documentation by bone scan and
x-ray required Number and extent of metastases determined according to Soloway and fitting
grades 1-3 Prior hormonal therapy must have lasted at least 3 months and must be continued
until completion of this study No imminent paraplegia related to metastases No
uncorrectable urinary incontinence

PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Hematopoietic: WBC
greater than 3,500 Platelets greater than 150,000 Hepatic: Not specified Renal: Creatinine
no greater than 2.2 mg/dl (200 micromoles/liter) Other: No calcium supplementation No
second malignancy except basal cell skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No restriction
Endocrine therapy: Prior and concurrent hormonal therapy required Radiotherapy: No prior
strontium-89 No prior hemibody or total-body irradiation Prior local-field irradiation for
bone metastases allowed provided new site of painful metastases exists Surgery: Surgical
castration allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

G. O. N. Oosterhof, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Academisch Ziekenhuis Maastricht

Authority:

United States: Federal Government

Study ID:

EORTC-30921

NCT ID:

NCT00002503

Start Date:

October 1992

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Prostate Cancer
  • recurrent prostate cancer
  • bone metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms

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