Hormone Therapy and Radiation Therapy in Treating Patients With Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00005044
First received: April 6, 2000
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of hormone therapy and radiation therapy is more effective for prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of hormone therapy and radiation therapy in treating patients who have prostate cancer.


Condition Intervention Phase
Prostate Cancer
Drug: bicalutamide
Drug: flutamide
Drug: releasing hormone agonist therapy
Procedure: neoadjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial to Evaluate the Duration of Neoadjuvant Total Androgen Suppression (TAS) and Radiation Therapy (RT) in Intermediate-Risk Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Disease-specific survival [ Time Frame: From the date of randomization to the date of death due to prostate cancer or last follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From the date of randomization to the date of death or last follow-up. Analysis will occur at the time of the primary endpoint analysis. ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: From the date of randomization to the date of disease progression, death from any cause, or last follow-up. Analysis will occur at the time of the primary endpoint analysis. ] [ Designated as safety issue: No ]
  • Clinical patterns of tumor recurrence [ Time Frame: From the date of randomization to the date of tumor recurrence or last follow-up. Analysis will occur at the time of the primary endpoint analysis. ] [ Designated as safety issue: No ]
  • Time to first biochemical failure [ Time Frame: From randomization to the date of first biochemical failure, defined as a consistent and significant rise in the serum PSA level, or last follow-up. Analysis will occur at the time of the primary endpoint analysis. ] [ Designated as safety issue: No ]
  • Time to second biochemical failure [ Time Frame: From randomization to the date of second biochemical failure, defined as a consistent and significant rise in the serum PSA level, or last follow-up. Analysis will occur at the time of the primary endpoint analysis. ] [ Designated as safety issue: No ]
  • Treatment-induced morbidity [ Time Frame: From start of treatment to 90 days from the end of treatment. ] [ Designated as safety issue: Yes ]

Enrollment: 1579
Study Start Date: February 2000
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAS x 8 weeks followed by RT with concurrent TAS
Total Androgen Suppression (TAS) (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by radiation therapy (RT) with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Drug: bicalutamide Drug: flutamide Drug: releasing hormone agonist therapy Procedure: neoadjuvant therapy Radiation: radiation therapy
Experimental: TAS x 28 weeks followed by RT with concurrent TAS
TAS (LHRH agonist and Casodex or Eulexin) x 28 weeks followed by RT with concurrent TAS (LHRH agonist and Casodex or Eulexin).
Drug: bicalutamide Drug: flutamide Drug: releasing hormone agonist therapy Procedure: neoadjuvant therapy Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

  • Compare the efficacy of moderate-duration (28 weeks) neoadjuvant total androgen suppression (TAS) and radiotherapy (RT) with short-duration (8 weeks) neoadjuvant TAS and RT, as related to disease-specific survival, in patients with intermediate-risk adenocarcinoma of the prostate.
  • Compare these regimens, in terms of overall survival, disease-free survival, time to local tumor progression or distant failure, time to first biochemical failure, hormone-refractory state, and treatment-induced morbidity, in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen level (no greater than 10 ng/mL vs greater than 10 but no greater than 20 ng/mL vs greater than 20 ng/mL), tumor stage (T1b-2 vs T3-4), Gleason score (2-4 vs 5-6 vs 7-10), and prior hormonal therapy (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive total androgen suppression for 8 weeks prior to the initiation of radiotherapy and throughout radiotherapy. A luteinizing hormone-releasing hormone (LHRH) agonist is administered every 1-3 months AND bicalutamide OR flutamide is given orally daily for a total duration of 16 weeks. Beginning with week 9, patients undergo radiotherapy 5 days a week for 8 weeks.
  • Arm II: Patients receive total androgen suppression for 28 weeks prior to the initiation of radiotherapy and throughout radiotherapy. An LHRH agonist AND bicalutamide OR flutamide are administered as in arm I for a total duration of 36 weeks. Beginning with week 29, patients undergo radiotherapy as in arm I.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,540 patients (770 per treatment arm) will be accrued for this study within 4 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Intermediate risk for disease relapse as determined by any of the following combination of factors:

    • T1b-4, Gleason score 2-6, and prostate-specific antigen (PSA) greater than 10 but no greater than 100 ng/mL
    • T1b-4, Gleason score 7, and PSA less than 20 ng/mL
    • T1b-1c, Gleason score 8-10, and PSA less than 20 ng/mL
  • Must have disease confirmation within 180 days of study randomization
  • Clinically negative lymph nodes (N0) as established by imaging or negative lymph nodes by nodal sampling or dissection

    • Radiologic or radioimmunoscintigraphy findings suggestive of regional nodal involvement allowed provided cytologic or histologic evaluation shows no evidence of a neoplastic process
    • Equivocal radiologic findings (i.e., maximum nodal size no greater than 1.5 cm) allowed
  • No distant metastases (M0)

    • Radionuclide imaging findings suggestive but not diagnostic of metastatic disease allowed provided radiologic imaging does not confirm metastatic disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0 or 1

Life expectancy:

  • At least 10 years

Hematopoietic:

  • Not specified

Hepatic:

  • ALT no greater than 2 times upper limit of normal

Renal:

  • Not specified

Other:

  • Fertile patients must use effective contraception
  • No other concurrent medical illness that would result in a life expectancy of less than 10 years
  • No other invasive malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
  • No other concurrent major medical or psychiatric illness that would preclude study treatment or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for prostate cancer

Endocrine therapy:

  • No prior androgen-deprivation therapy except luteinizing hormone-releasing hormone (LHRH) agonist AND bicalutamide OR flutamide provided:

    • LHRH agonist was initiated no more than 30 days before study randomization and bicalutamide OR flutamide was initiated no more than 14 days before or after LHRH agonist administration
  • No concurrent finasteride for prostatic hypertrophy

Radiotherapy:

  • No prior pelvic external beam radiotherapy
  • No prior radionuclide prostate brachytherapy
  • No concurrent intensity-modulated radiotherapy

Surgery:

  • No prior prostatectomy
  • No prior prostatic cryosurgery
  • No prior bilateral orchiectomy

Other:

  • No other concurrent medical research study involving prostate cancer treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005044

  Show 261 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: Michael G. Haddock, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Paner GP, Bae K, Grignon DJ, et al.: Trends in Gleason grading of prostate cancer (PCa): analysis of reporting by institutional and central review pathologists in four Radiation Therapy Oncology Group (RTOG) protocols spanning 17 years and 2094 needle biopsies (bxs). [Abstract] United States and Canadian Academy of Pathology 96th Annual Meeting, March 24-30, 2007, San Diego, CA. A-766, 2007.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00005044     History of Changes
Other Study ID Numbers: RTOG-9910, CDR0000067635
Study First Received: April 6, 2000
Last Updated: May 16, 2014
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Bicalutamide
Hormones
Androgen Antagonists
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014