Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments brachytherapy, 125-iodine, 103-palladium
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date May 2007
End date June 2016
Trial size 100 participants
Trial identifier NCT00450411, CDR0000533887, RTOG-0526

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients will receive either 125-iodine (I-125) 140 Gy minimum target dose or 103-palladium (Pd-103) 120 Gy minimum target dose.
brachytherapy
125-iodine
103-palladium

Primary Outcomes

Measure
Late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events
time frame: Between 271 days and 730 days from brachy implant

Secondary Outcomes

Measure
Acute treatment-related GI and GU adverse events
time frame: 270 days from the date of brachy implant
Overall survival
time frame: From the date of registration to the date of death due to any cause
Disease-free survival
time frame: From the date of registration to the date of first documented disease progression or date of death due to any cause
Disease-specific survival
time frame: From the date of registration to the date of death due to prostate cancer or death from the complication of therapy irrespective of disease status
Local tumor progression
time frame: From the date of registration to the date of first documented disease progression or date of death due to any cause
Distant failure
time frame: From the date of registration to the date of first documented lymphatic or hematogenous metastatic disease
Biochemical (PSA) failure
time frame: From date of registration to date of PSA failure (PSA > current nadir +2) or date starting secondary intervention whichever comes first

Eligibility Criteria

Male participants from 18 years up to 120 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate meeting the following criteria: - Stage I-II disease (T1-T2c) at initial diagnosis (prior to external-beam radiotherapy), meeting one of the following criteria: - Gleason score 7 and prostate-specific antigen (PSA) ≤ 10 ng/mL - Gleason score 2-7 and PSA ≤ 20 ng/mL - Locally recurrent disease > 30 months after completion of prior external-beam radiotherapy - Has undergone prostate biopsy within the past 180 days - Prostate volume ≤ 45 mL as measured by transrectal ultrasound or pubic arch interference ruled out - American Urological Association (AUA) Symptom Index Score < 15 - 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 allowed) - Baseline serum PSA < 10 ng/mL within 8 weeks prior to study entry OR within 8 weeks prior to initiation of hormonal therapy OR more than 10 days prior to prostate biopsy - No histologic or radiologic evidence of tumor involvement of regional lymph nodes (N1) - Negative lymph nodes by imaging (pelvic with or without abdominal CT scan or MRI), or by nodal dissection (laparoscopy or laparotomy) within the past 8 weeks - No clinical and/or radiologic evidence of extraprostatic disease at initial diagnosis (i.e., prior to external-beam radiotherapy) or at the time of local recurrence (i.e., prior to study entry) - No evidence of bone metastases (M0) on bone scan within the past 8 weeks or other metastatic disease (M1) PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Must be suitable for spinal or general anesthesia - No prior invasive (except nonmelanoma skin cancer) or hematological (e.g., acute leukemia, aggressive lymphoma, myeloma) malignancy unless disease-free for ≥ 3 years - Prior low-grade lymphoma or chronic lymphocytic leukemia allowed - No persistent late gastrointestinal or genitourinary toxicity ≥ grade 2 - No severe, active comorbidity, including any of the following: - Unstable angina and/or decompensated congestive heart failure - Myocardial infarction within the past 6 months - Bacterial or fungal infection requiring intravenous antibiotics - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Acquired immune deficiency syndrome (AIDS) PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior transurethral resection of the prostate - No prior radionuclide (permanent or temporary implantation) prostate brachytherapy - No prior prostatectomy or prostatic cryosurgery - No prior high-intensity focused ultrasound - No prior bilateral orchiectomy - No prior chemotherapy for prostate cancer - At least 2 months but ≤ 6 months since initiation of prior luteinizing hormone-releasing hormone agonist - Any combination of prior neoadjuvant, concurrent, or adjuvant androgen suppression therapy at the time of initial diagnosis and external-beam radiotherapy allowed provided the total duration of treatment was ≤ 8 months - If the total duration of treatment was > 8 months, evidence of a normal serum testosterone must be documented - No prior external-beam radiotherapy 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)

Additional Information

Official title A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.