Clinical trial NCT00450411: Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy
Official title: A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Lead sponsor: Radiation Therapy Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: NRG Oncology
First posted: 2007-03-22
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE)
timeFrame: Between 271 days and 730 days from date of implantation
Secondary outcomes:
measure: Number of Patients With Acute Treatment-related GI and GU Adverse Events
timeFrame: From date of implantation to 270 days
measure: Percentage of Participants Alive at 5 Years (Overall Survival)
timeFrame: From registration to 5 years
measure: Percentage of Participants Alive Without Disease (Disease-free Survival)
timeFrame: From registration to 5 years
measure: Percentage of Participants With Prostate Cancer Death at 5 Years (Disease-specific Survival)
timeFrame: From registration to 5 years
measure: Percentage of Participants With Local Failure at 5 Years
timeFrame: From registration to 5 years
measure: Percentage of Participants With Distant Failure at 5 Years
timeFrame: From registration to 5 years
measure: Percentage of Participants With Biochemical Failure at 4 Years
timeFrame: From registration to 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Oncology Services Foundation
state: Arizona
city: Fresno
country: United States
facility: California Cancer Center - Woodward Park Office
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center at UC Health Sciences Center
state: Colorado
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Springfield
country: United States
facility: Cancer Institute at St. John's Hospital
state: Illinois
city: Saint Louis
country: United States
facility: Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
state: Missouri
city: Akron
country: United States
facility: McDowell Cancer Center at Akron General Medical Center
state: Ohio
city: Ravenna
country: United States
facility: Robinson Radiation Oncology
state: Ohio
city: Sylvania
country: United States
facility: Flower Hospital Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
state: Pennsylvania
city: Milwaukee
country: United States
facility: Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
state: Wisconsin
city: West Allis
country: United States
facility: West Allis Memorial Hospital
state: Wisconsin
city: Edmonton
country: Canada
facility: Cross Cancer Institute at University of Alberta
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency - Centre for the Southern Interior
state: British Columbia
city: Toronto
country: Canada
facility: Odette Cancer Centre at Sunnybrook
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: British Columbia Cancer Agency
name: Juanita M. Crook, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.