NCT00091390

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving internal radiation therapy together with external-beam radiation therapy works in treating patients with stage II or stage III prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

12 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

Study Start

First participant enrolled

July 1, 2004

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 9, 2004

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

November 14, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 10, 2020

Status Verified

July 1, 2020

Enrollment Period

3.5 years

First QC Date

September 7, 2004

Results QC Date

October 31, 2014

Last Update Submit

July 28, 2020

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage IIB prostate cancerstage IIA prostate cancerstage III prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Late Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE) at 18 Months

    Adverse events (AE) were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. "Late" is defined as occurring after 9 months from the start of study treatment. Because of the lead time of 9 months, the percentage at 18-months was estimated by the 9-month rate using the cumulative incidence method starting at the 10th month. Death was treated as a competing risk.

    From 9 to 18 months after start of study treatment

Secondary Outcomes (7)

  • Number of Participants With Acute Grade 3-5 Genitourinary (GU) and Gastrointestinal (GI) Adverse Events (AE)

    From treatment start to 9 months

  • Percentage of Participants With Biochemical Failure at 10 Years Using American Society for Therapeutic Radiation and Oncology (ASTRO) Definition

    From registration to ten years

  • Percentage of Participants With Biochemical Failure at 10 Years Using the Phoenix Definition

    From registration to ten years

  • Percentage of Participants Alive at 10 Years

    From registration to 10 years

  • Percentage of Participants With Death Due to Prostate Cancer at 10 Years

    From registration to ten years

  • +2 more secondary outcomes

Study Arms (1)

External Beam Radiotherapy and High Dose brachytherapy boost

EXPERIMENTAL
Radiation: High Dose brachytherapy boostRadiation: External beam radiotherapy

Interventions

High Dose brachytherapy boostRADIATION

19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks.

Also known as: HDR brachytherapy boost
External Beam Radiotherapy and High Dose brachytherapy boost
External beam radiotherapyRADIATION

45 Gy as 1.8 Gy five days a week for five weeks.

Also known as: XRT, External beam RT
External Beam Radiotherapy and High Dose brachytherapy boost

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0, M0.
  • Patient will have clinically negative nodes as established by imaging (pelvic computed tomography (CT), magnetic resonance imaging (MRI)).
  • The patient will be clinically M0.
  • Zubrod status 0-1.
  • No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction hormonal therapy beginning ≤ 120 days prior to registration is acceptable.
  • One of the following combinations of factors:
  • Clinical stage T1c-T2c, Gleason score 2-6 and prostate-specific antigen (PSA) \>10 but ≤ 20 Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20 Clinical stage T1c-T3b, Gleason score 7-10 and PSA ≤ 20
  • Patients must sign a study-specific consent form prior to registration.

You may not qualify if:

  • Stage T4 disease.
  • Lymph node involvement (N1).
  • Evidence of distant metastases (M1).
  • Radical surgery for carcinoma of the prostate.
  • Previous hormonal therapy beginning \> 120 days prior to registration.
  • Major medical or psychiatric illness which, in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
  • Prior transurethral resection of the prostate (TURP).
  • Prior invasive malignancy(except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (For example, carcinoma in situ of the oral cavity or bladder are permissible).
  • Hip prosthesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital

Inglewood, California, 90301, United States

Location

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, 95815, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Lynn Regional Cancer Center at Boca Raton Community Hospital - Main Center

Boca Raton, Florida, 33486, United States

Location

OSF St. Francis Medical Center

Peoria, Illinois, 61637, United States

Location

Maine Center for Cancer Medicine and Blood Disorders - Scarborough

Scarborough, Maine, 04074, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, 53188, United States

Location

Related Publications (3)

  • Hsu IC, Bae K, Shinohara K, Pouliot J, Purdy J, Ibbott G, Speight J, Vigneault E, Ivker R, Sandler H. Phase II trial of combined high-dose-rate brachytherapy and external beam radiotherapy for adenocarcinoma of the prostate: preliminary results of RTOG 0321. Int J Radiat Oncol Biol Phys. 2010 Nov 1;78(3):751-8. doi: 10.1016/j.ijrobp.2009.08.048. Epub 2010 Mar 6.

    PMID: 20207506RESULT

  • Jacob D, Raben A, Sarkar A, Grimm J, Simpson L. Anatomy-based inverse planning simulated annealing optimization in high-dose-rate prostate brachytherapy: significant dosimetric advantage over other optimization techniques. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):820-7. doi: 10.1016/j.ijrobp.2008.02.009. Epub 2008 May 1.

    PMID: 18455325RESULT

  • Hsu IC, Rodgers JP, Shinohara K, Purdy J, Michalski J, Roach M 3rd, Vigneault E, Ivker RA, Pryzant RM, Kuettel M, Taussky D, Gustafson GS, Raben A, Sandler HM. Long-Term Results of NRG Oncology/RTOG 0321: A Phase II Trial of Combined High Dose Rate Brachytherapy and External Beam Radiation Therapy for Adenocarcinoma of the Prostate. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):700-707. doi: 10.1016/j.ijrobp.2020.11.008. Epub 2020 Nov 10.

    PMID: 33186617DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Wendy Seiferheld
Organization
NRG Oncology
seiferheldw@nrgoncology.org

Study Officials

  • I-Chow J. Hsu, MD

    University of California, San Francisco

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2004

First Posted

September 9, 2004

Study Start

July 1, 2004

Primary Completion

January 1, 2008

Study Completion

December 1, 2016

Last Updated

August 10, 2020

Results First Posted

November 14, 2014

Record last verified: 2020-07

Locations

US(12)