Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer

Overview

About this study

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II, stage III, or recurrent prostate cancer and elevated PSA levels following radical prostatectomy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

DISEASE CHARACTERISTICS:

  • Carcinoma of the prostate with pathologic stage T3 N0 or pT2 pN0 with positive inked resection margin at least 12 weeks prior to study entry
  • Radical prostatectomy (retropubic or perineal) and pelvic lymphadenectomy (open or laparoscopic) required at least 16 weeks prior to entry
    • No persistent urinary extravasation after surgery
  • Suitable for radiotherapy and hormonal therapy as determined by the radiation oncologist and urologist
  • No metastasis by post-prostatectomy radioisotope bone scan within 16 weeks prior to entry
  • Pathologic stage T2 without positive margins and pathologic N0 with prostatic fossa/anastamosis biopsy at the time of rising PSA documenting recurrent cancer allowed
  • PSA 0.2-4.0 ng/mL at study entry
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Age: Any age
  • Performance status: Karnofsky 80-100%
  • Life expectancy: More than 10 years
  • Hematopoietic:
    • White blood cell count (WBC) at least 4,000/mm^3
    • Platelet count at least 100,000/mm^3
    • Hematocrit at least 36%
    • Hemoglobin at least 10 g/dL
  • Hepatic:
    • Bilirubin normal
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) no greater than 2.5 times normal
  • Renal: Creatinine no greater than 2 times normal
  • Other: No other malignancy within the past 5 years except basal or squamous cell skin cancer or adequately treated invasive cancers

PRIOR CONCURRENT THERAPY:

  • Biologic therapy: No prior biologic therapy for prostate cancer
  • Chemotherapy: No prior chemotherapy for prostate cancer
  • Endocrine therapy:
    • No prior adjuvant hormonal therapy
    • Prior neoadjuvant hormonal therapy allowed
  • Radiotherapy: No prior radiotherapy for prostate cancer
  • Surgery: See Disease Characteristics

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Thomas Pisansky, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Thomas Pisansky, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Thomas Pisansky, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20154144

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