NCT00063882|CompletedPhase 3ResultsDMC

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

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

Radiation Therapy Oncology Group ClinicalTrials.gov

Compare

3 other identifiers

RTOG 0232CDR0000288823NCI-2009-01091

Study Type

interventional

Target

588

Locations

2 countries

Sites

170

Timeline

RegisteredJul 2003

StartedJun 2003

CompletionDec 2022

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

588

participants targeted

Target at P50-P75 for phase_3 prostate-cancer

Timeline

Completed

Started Jun 2003

Longer than P75 for phase_3 prostate-cancer

Geographic Reach

2 countries

170 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

19.6 years study duration

Study Start

First participant enrolled

June 1, 2003

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed

13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

October 16, 2019

Completed

3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2022

Completed

Last Updated

March 5, 2026

Status Verified

December 1, 2022

Enrollment Period

13.9 years

First QC Date

July 8, 2003

Results QC Date

May 21, 2019

Last Update Submit

February 11, 2026

Conditions

Prostate Cancer

Keywords

stage IIB prostate cancerstage IIA prostate canceradenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

5-Year Freedom From Progression Rate
A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.
From randomization to 5 years

Secondary Outcomes (14)

Biochemical Failure Rate (Protocol Definition)
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Biochemical Failure (Phoenix Definition)
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.Maximum follow-up at time of analysis was 13.9 years.
Prostate Cancer Death
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Local Failure
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
Distant Metastases
From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.
+9 more secondary outcomes

Other Outcomes (3)

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
Analysis occurs after all patients have been potentially followed for 5 years.
5-Year Freedom From Progression Rate by Ethnicity
From randomization to 5 years
5-Year Freedom From Progression Rate by Race
From randomization to 5 years

Study Arms (2)

EBRT + Brachytherapy

EXPERIMENTAL

External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)

Radiation: Brachytherapy (100/110)Radiation: External Beam Radiation Therapy

Brachytherapy Only

ACTIVE COMPARATOR

Transperineal interstitial permanent brachytherapy (125/145)

Radiation: Brachytherapy (125/145)

Interventions

Brachytherapy (100/110)RADIATION

100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy.

EBRT + Brachytherapy

Brachytherapy (125/145)RADIATION

125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.

Brachytherapy Only

External Beam Radiation TherapyRADIATION

Total dose of 45 Gy to the prostate and seminal vesicles as a daily dose of 1.8 Gy given 5 times per week. The prescribed dose is defined at the International Commission of Radiation Units and Measurements (ICRU) reference point. Both 3D-conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) are permitted.

Also known as: EBRT

EBRT + Brachytherapy

Eligibility Criteria

Age18 Years - 120 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Radiation Therapy Oncology Grouplead
National Cancer Institute (NCI)collaborator
NRG Oncologycollaborator

Study Sites (170)

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

Auburn Radiation Oncology

Auburn, California, 95603, United States

Location

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Peninsula Medical Center

Burlingame, California, 94010, United States

Location

Radiation Oncology Centers - Cameron Park

Cameron Park, California, 95682, United States

Location

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, 95608, United States

Location

East Bay Radiation Oncology Center

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, 94546, United States

Location

Valley Medical Oncology

Fremont, California, 94538, United States

Location

California Cancer Center - Woodward Park Office

Fresno, California, 93720, United States

Location

Kaiser Permanente Medical Center - Hayward

Hayward, California, 94545, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553-3156, United States

Location

El Camino Hospital Cancer Center

Mountain View, California, 94040, United States

Location

Sutter Health - Western Division Cancer Research Group

Novato, California, 94945, United States

Location

Alta Bates Summit Medical Center - Summit Campus