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

NCT ID: NCT00450411

Last Updated: 2022-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2022-05-20

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.

Detailed Description

OBJECTIVES:

Primary

• Determine the late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events in patients with locally recurrent adenocarcinoma of the prostate previously treated with external-beam radiotherapy who are currently receiving transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.

Secondary

• Determine the acute treatment-related GI and GU adverse events in patients treated with this regimen.
• Determine the overall survival of patients treated with this regimen.
• Determine the disease-free survival of patients treated with this regimen.
• Determine the disease-specific survival of patients treated with this regimen.
• Determine clinical patterns of tumor recurrence (time to local tumor progression or distant failure) in patients treated with this regimen.
• Determine the time to biochemical failure in patients treated with this regimen.
• Determine the post-brachytherapy dosimetric coverage in patients treated with this regimen.

OUTLINE: This is a prospective, multicenter study.

Patients undergo transperineal ultrasound-guided iodine I 125 or palladium Pd 103 brachytherapy.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 96 patients will be accrued for this study.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brachytherapy

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

Group Type: EXPERIMENTAL

125-Iodine

Intervention Type: RADIATION

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

103-palladium

Intervention Type: RADIATION

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

Interventions

125-Iodine

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

Intervention Type: RADIATION

103-palladium

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

Intervention Type: RADIATION

Other Intervention Names

brachytherapy; brachytherapy

Eligibility Criteria

Inclusion Criteria

1. 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

2. 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

3. Staging, performed within 8 weeks prior to registration:

• 3.1 History/physical examination (to include at a minimum digital rectal examination of the prostate and examination of the skeletal system and abdomen)
• 3.2 Negative lymph nodes by imaging (pelvic ± abdominal CT or MR), or by nodal dissection (laparoscopy or laparotomy)
• 3.3 No evidence of bone metastases (M0) on bone scan

4. Zubrod Performance Scale 0-1

5. 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)

6. Age ≥ 18

7. 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.

8. Prostate volume as measured by transrectal ultrasound (TRUS) ≤ 45 cc or pubic arch interference ruled out

9. The patient must be suitable for spinal or general anesthesia

10. The patient must sign a study-specific informed consent form before study entry

Exclusion Criteria

1. 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.

2. 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)

3. 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.

4. Severe, active co-morbidity, defined as follows:

• 4.1 Unstable angina and/or decompensated congestive heart failure
• 4.2 Myocardial infarction within the last 6 months
• 4.3 Bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• 4.4 Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
• 4.5 Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
• 4.6 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.

5. 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)

6. Any of the following prior therapies:

• Transurethral resection of the prostate (TURP)
• Radionuclide (permanent or temporary implantation) prostate brachytherapy
• Prostatectomy or prostatic cryosurgery
• High-intensity focused ultrasound (HIFU)
• Bilateral orchiectomy
• Chemotherapy for prostatic carcinoma
• NOTE 1: Androgen suppression therapy is permissible provided that the luteinizing hormone-releasing hormone (LHRH) agonist was started at least 2 months and no more than 6 months before registration.
• NOTE 2: Any combination of neoadjuvant, concurrent, or adjuvant androgen suppression therapy at the time of initial external radiotherapy is permissible provided the total duration was ≤ 8 months. If > 8 months, evidence of a normal serum testosterone must be documented.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

NRG Oncology

OTHER

Sponsor Role: collaborator

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juanita M. Crook, MD

Role: STUDY_CHAIR

British Columbia Cancer Agency

Locations

Arizona Oncology Services Foundation

Phoenix, Arizona, United States

California Cancer Center - Woodward Park Office

Fresno, California, United States

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, United States

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Cancer Institute at St. John's Hospital

Springfield, Illinois, United States

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

City of Saint Peters, Missouri, United States

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, United States

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, United States

Robinson Radiation Oncology

Ravenna, Ohio, United States

Flower Hospital Cancer Center

Sylvania, Ohio, United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, United States

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

Milwaukee, Wisconsin, United States

West Allis Memorial Hospital

West Allis, Wisconsin, United States

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, Canada

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, Canada

Odette Cancer Centre at Sunnybrook

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 34740768 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30312717 (View on PubMed)

Other Identifiers

CDR0000533887

Identifier Type: -

Identifier Source: secondary_id

RTOG-0526

Identifier Type: -

Identifier Source: org_study_id