Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

This study has been completed.
Sponsor:
Collaborators:
Kent E. Wallner, M.D.
Sylvester, John, M.D.
Information provided by (Responsible Party):
Gregory Merrick, M.D., Schiffler Cancer Center
ClinicalTrials.gov Identifier:
NCT00243646
First received: October 20, 2005
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

Determine the role of androgen deprivation therapy in high risk patients receiving 45 Gy of pelvic radiotherapy plus a Pd-103 boost and the impact of the duration of ADT in hormonally-manipulated patients.


Condition Intervention Phase
Prostate Cancer
Radiation: External beam radiation
Drug: Lupron
Drug: Casodex
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Implant and External Radiation for Prostate Cancer With or Without Hormonal Therapy: A Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Schiffler Cancer Center:

Primary Outcome Measures:
  • PSA 3 and 6 months following implantation then every 6 months. [ Time Frame: 3 and 6 months following implantation then every 6 months ] [ Designated as safety issue: No ]
    PSA 3 and 6 months following implantation then every 6 months.

  • Serum testosterone levels at 3 and 6 months in hormonally manipulated patients. [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
    Serum testosterone levels at 3 and 6 months in hormonally manipulated patients

  • Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected. [ Time Frame: as needed ] [ Designated as safety issue: No ]
    Androgen deprivation therapy will not be reinitiated unless the post-treatment PSA exceeds 10 ng/mL or distant metastases are detected.


Secondary Outcome Measures:
  • EPIC on 6 and 12 months and then annually. [ Time Frame: 6 and 12 months and then annually. ] [ Designated as safety issue: No ]
    EPIC on 6 and 12 months and then annually.

  • Hormonally manipulated patients will obtain a DEXA scan. [ Time Frame: as needed ] [ Designated as safety issue: No ]
    Hormonally manipulated patients will obtain a DEXA scan.

  • For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended. [ Time Frame: every 3 months is recommended. ] [ Designated as safety issue: No ]
    For documented osteoporosis, Zometa (4 mg IV over 15 minutes) every 3 months is recommended.


Enrollment: 6
Study Start Date: August 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: no hormones
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with no hormones
Radiation: External beam radiation
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant
Active Comparator: 9 months of hormone therapy
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant with a 9 month course of hormone therapy
Radiation: External beam radiation
All patients will receive a 5-week course of external beam radiation therapy to the pelvis and a Pd-103 brachytherapy implant
Drug: Lupron
9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).
Drug: Casodex
9 months of an LHRH agonist and 4 months of an anti-androgen) is optimal for securing long-term biochemical control (a stable, non-rising PSA).

Detailed Description:

In calender year 2005, 220, 000 men will be diagnosed with prostate cancer and approximately 30,000 will subsequently die of metastatic disease. Although the vast majority of men will be diagnosed with clinically localized and potentially curable disease, the selection of one local modality over another remains a focus of significant controversy within the uro-oncology community. However, patients with higher risk features are most often managed with radiotherapeutic approaches to include androgen deprivation therapy.

Prostate brachytherapy represents the ultimate-three dimensional conformal therapy and permits dose escalation far exceeding other modalities. Following permanent prostate brachytherapy with or without supplemental external beam radiation therapy, favorable long-term biochemical outcomes have been reported for patients with low, intermediate and high risk features with a morbidity profile that compares favorably with competing local modalities (1,2).

Several prospective randomized trials have demonstrated that androgen deprivation therapy in conjunction with conventional doses of external beam radiation therapy (65-70 Gy)results in improvement in disease-free and overall survival in patients with locally advanced prostate cancer (3,4).

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • High risk patients - Two to three of the following: PSA 10-30 ng/mL, Gleason score greater than or equal to 6, clinical stage greater than or equal to T2c (2002 ACJJ).
  • CT of the abdomen and pelvis and bone scan without evidence of metastases.
  • An enzymatic prostatic acid phosphatase must be obtained prior to randomization.
  • A serum testosterone must be obtained prior to initiation of androgen deprivation therapy.
  • No prior pelvic external beam radiation therapy for prostate cancer or other malignancies.
  • No prior androgen deprivation therapy.
  • Minimum 5 year life expectancy.
  • No other invasive cancer diagnosis other than non-melanoma skin cancer within the last 5 years.

Exclusion Criteria:

  • Exclusion criteria will be limited to patients who do not meet the above eligibility criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00243646

Locations
United States, Washington
Groupe Health Cooperative, Veterans Adminstration Hospital and University of Washington
Seattle, Washington, United States, 98108
Seattle Prostate Institute
Seattle, Washington, United States, 98104
United States, West Virginia
Schiffler Cancer Center
Wheeling, West Virginia, United States, 26003
Sponsors and Collaborators
Schiffler Cancer Center
Kent E. Wallner, M.D.
Sylvester, John, M.D.
Investigators
Principal Investigator: Gregory S Merrick, MD Schiffler Cancer Center, Wheeling, WV
Study Chair: Kent E. Wallner, MD Group Health Cooperative, Veterans Administration Hospital, and University of Washington
Study Chair: John Sylvester, MD Seattle Prostate Institute Seattle, WA 98104
  More Information

Publications:

Responsible Party: Gregory Merrick, M.D., Medical Director, Schiffler Cancer Center
ClinicalTrials.gov Identifier: NCT00243646     History of Changes
Other Study ID Numbers: 05-8-4
Study First Received: October 20, 2005
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Schiffler Cancer Center:
Radiation therapy
Brachytherapy
Prostatic neoplasm

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

ClinicalTrials.gov processed this record on April 17, 2014