Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy

NCT00450411 | Completed Phase 2 Results DMC

• 2 other identifiers: RTOG-0526CDR0000533887
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 17

Brief Summary

RATIONALE: Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. PURPOSE: This phase II trial is studying the side effects and how well ultrasound-guided implant radiation therapy works in treating patients with locally recurrent prostate cancer previously treated with external-beam radiation therapy.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)

  Adverse events are graded using 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 AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. For the purposes of this study, late treatment-related adverse events were evaluated between 271 days and 730 days from the implant.

  Between 271 days and 730 days from date of implantation

Secondary Outcomes (7)

• Number of Patients With Acute Treatment-related GI and GU Adverse Events

  From date of implantation to 270 days

• Percentage of Participants Alive at 5 Years (Overall Survival)

  From registration to 5 years

• Percentage of Participants Alive Without Disease (Disease-free Survival)

  From registration to 5 years

• Percentage of Participants With Prostate Cancer Death at 5 Years (Disease-specific Survival)

  From registration to 5 years

• Percentage of Participants With Local Failure at 5 Years

  From registration to 5 years

Study Arms (1)

Brachytherapy

EXPERIMENTAL

Prostate brachytherapy delivered using either 125-iodine (I-125) or 103-palladium (Pd-103)

Radiation: 125-Iodine; Radiation: 103-palladium

Interventions

125-Iodine RADIATION

Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy

Also known as: brachytherapy

Brachytherapy

103-palladium RADIATION

Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy

Also known as: brachytherapy

Brachytherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy-documented locally recurrent prostatic adenocarcinoma \> 30 months after the completion of EBRT, biopsied ≤ 180 days prior to registration and confirmed by central pathology review
• Disease-related characteristics at initial diagnosis (i.e., prior to EBRT) that fit the following criteria: Stages T1-T2c, Gleason scores 2-7, and PSA ≤ 20 ng/mL
• Staging, performed within 8 weeks prior to registration:
• History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen)
• Negative lymph nodes by imaging (pelvic ± abdominal CT or MR), or by nodal dissection (laparoscopy or laparotomy)
• No evidence of bone metastases (M0) on bone scan
• Zubrod Performance Scale 0-1
• American Urological Association Symptom Index Score (AUA BPH) \< 15 (Note: The use of alpha blockers is permitted when evaluating lower urinary tract symptoms, i.e., the AUA score with the patient on alpha blockers is acceptable)
• Age ≥ 18
• Baseline serum prostate-specific antigen (PSA) value \< 10 ng/mL performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 8 weeks prior to registration. PSA should not be performed within 10 days of a prior prostate biopsy, and if the patient has been started on hormonal therapy, the PSA should be performed within 8 weeks prior to the commencement of hormonal therapy.
• Prostate volume as measured by transrectal ultrasound (TRUS) ≤ 45 cc or pubic arch interference ruled out
• The patient must be suitable for spinal or general anesthesia
• The patient must sign a study-specific informed consent form before study entry

You may not qualify if:

• Prior invasive (except non-melanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for a minimum of 3 years. Previous diagnosis of low-grade lymphoma or chronic lymphocytic leukemia is allowed.
• Prior EBRT to the prostate such that the minimum dose to the prostate exceeded 78 Gy (2 Gy fractions) or 79.8 Gy (1.9 Gy fractions) or 81 Gy (1.8 Gy fractions)
• Baseline gastrointestinal (GI) or genitourinary (GU) toxicity (for any reason) grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or decompensated congestive heart failure
• Myocardial infarction within the last 6 months
• Bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• Clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis (i.e., prior to EBRT) or at time of local recurrence (i.e., prior to study registration)
• ° 5.1 Histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) or the presence of metastatic disease (M1)
• Any of the following prior therapies:
• Transurethral resection of the prostate (TURP)
• Radionuclide (permanent or temporary implantation) prostate brachytherapy

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (17)

Arizona Oncology Services Foundation

Phoenix, Arizona, 85013, United States

Location

California Cancer Center - Woodward Park Office

Fresno, California, 93720, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Cancer Institute at St. John's Hospital

Springfield, Illinois, 62702, United States

Location

Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters

City of Saint Peters, Missouri, 63376, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Robinson Radiation Oncology

Ravenna, Ohio, 44266, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

West Allis Memorial Hospital

West Allis, Wisconsin, 53227, United States

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Odette Cancer Centre at Sunnybrook

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• Crook J, Rodgers JP, Pisansky TM, Trabulsi EJ, Amin MB, Bice W, Morton G, Murtha AD, Vigneault E, Helou J, Michalski JM, Roach M 3rd, Beyer D, Jani AB, Horwitz EM, Raben A, Pugh S, Sandler H. Salvage Low-Dose-Rate Prostate Brachytherapy: Clinical Outcomes of a Phase 2 Trial for Local Recurrence after External Beam Radiation Therapy (NRG Oncology/RTOG 0526). Int J Radiat Oncol Biol Phys. 2022 Apr 1;112(5):1115-1122. doi: 10.1016/j.ijrobp.2021.10.138. Epub 2021 Nov 3.

  PMID: 34740768 DERIVED

• Crook JM, Zhang P, Pisansky TM, Trabulsi EJ, Amin MB, Bice W, Morton G, Pervez N, Vigneault E, Catton C, Michalski J, Roach M 3rd, Beyer D, Jani A, Horwitz E, Donavanik V, Sandler H. A Prospective Phase 2 Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Cancer After External Beam Radiation Therapy (NRG Oncology/RTOG-0526). Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):335-343. doi: 10.1016/j.ijrobp.2018.09.039. Epub 2018 Oct 9.

  PMID: 30312717 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Iodine-125; Brachytherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Results Point of Contact

• Title: Wendy Seiferheld, M.S.
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Juanita M. Crook, MD

  British Columbia Cancer Agency

  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: March 20, 2007
• First Posted: March 22, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2016
• Study Completion: May 20, 2022
• Last Updated: June 21, 2022
• Results First Posted: November 7, 2017

Record last verified: 2022-05

Locations

US (13); CA (4)