Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer - Full Text View

Sponsor:	Radiation Therapy Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00063882

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.

Condition	Intervention	Phase
Prostate Cancer	Radiation: iodine I 125 Radiation: palladium Pd 103 Radiation: radiation therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Primary Purpose: Treatment
Official Title:	A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Iodine Iodide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Freedom from progression [ Designated as safety issue: No ]

Secondary Outcome Measures:

Biochemical (i.e., prostate-specific antigen) failure for at least 5 years [ Designated as safety issue: No ]
Biochemical failure by the Phoenix definition [ Designated as safety issue: No ]
Disease-specific survival [ Designated as safety issue: No ]
Local progression [ Designated as safety issue: No ]
Distant metastases [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Incidence of "acute" toxicities [ Designated as safety issue: Yes ]
Time to "late" 3+ toxicities [ Designated as safety issue: Yes ]
Health-related quality of life as measured by EPIC, EQ5D, and AUA-SI from baseline to 4 months (early) and then at 2 years (late) after initiation of therapy [ Designated as safety issue: No ]
Feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and external beam radiotherapy [ Designated as safety issue: No ]

Estimated Enrollment:	586
Study Start Date:	June 2003
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.	Radiation: iodine I 125 Given as interstitial seeds Radiation: palladium Pd 103 Given as interstitial seeds Radiation: radiation therapy Given as external beam radiation therapy over 5 weeks
Active Comparator: Arm II Patients undergo interstitial brachytherapy only, as in arm I.	Radiation: iodine I 125 Given as interstitial seeds Radiation: palladium Pd 103 Given as interstitial seeds

Detailed Description:

OBJECTIVES:

Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT).
Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
Compare morbidity and quality of life of patients treated with these regimens.
Determine the feasibility of collecting Medicare data in a large RTOG prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT.
Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years.

After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.

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
- T1c-T2b, N0, M0
Intermediate-risk disease, as defined by 1 of the following:
- Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
- Gleason score 7 AND PSA < 10 ng/mL
No evidence of distant metastases
Prostate volume ≤ 60 cc by transrectal ultrasonography
American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Patients must use effective contraception
No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site
No major medical or psychiatric illness that would preclude study therapy
No hip prosthesis

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

No prior chemotherapy

Endocrine therapy

Prior neoadjuvant hormonal therapy allowed provided the following are true:
- Therapy was initiated within 2-6 months of study enrollment
- Therapy was no more than 6 months in duration
- Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration
No concurrent hormonal therapy

Radiotherapy

No prior pelvic radiotherapy

Surgery

No prior radical surgery for prostate cancer
No prior transurethral resection of the prostate
No prior cryosurgery

Other

No prior transurethral needle ablation of the prostate
No prior transurethral microwave thermotherapy of the prostate

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063882

Show 202 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Bradley R. Prestidge, MD

Texas Cancer Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Walter John Curran, Jr, Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT00063882 History of Changes
Other Study ID Numbers:	CDR0000288823, RTOG-0232, CTSU
Study First Received:	July 8, 2003
Last Updated:	April 26, 2011
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IIB prostate cancer
stage IIA prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Iodine

Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 24, 2012