Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Radiation: brachytherapy Radiation: iodine I 125 Radiation: palladium Pd 103 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy |
- Late treatment-related gastrointestinal (GI) and genitourinary (GU) adverse events [ Designated as safety issue: Yes ]
- Acute treatment-related GI and GU adverse events [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Disease-specific survival [ Designated as safety issue: No ]
- Local tumor progression [ Designated as safety issue: No ]
- Distant failure [ Designated as safety issue: No ]
- Biochemical failure [ Designated as safety issue: No ]
- Post-brachytherapy dosimetric coverage [ Designated as safety issue: No ]
| Estimated Enrollment: | 96 |
| Study Start Date: | May 2007 |
| Estimated Primary Completion Date: | February 2016 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| United States, Arizona | |
| Arizona Oncology Services Foundation | Recruiting |
| Phoenix, Arizona, United States, 85013 | |
| Contact: David G. Brachman, MD, FACRO 602-274-4484 | |
| United States, California | |
| California Cancer Center - Woodward Park Office | Recruiting |
| Fresno, California, United States, 93720 | |
| Contact: Brent L. Kane 559-447-4050 | |
| United States, Colorado | |
| University of Colorado Cancer Center at UC Health Sciences Center | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Clinical Trials Office - University of Colorado Cancer Center 720-848-0650 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Clinical Trials Office - Winship Cancer Institute 404-778-1900 | |
| United States, Illinois | |
| Cancer Institute at St. John's Hospital | Recruiting |
| Springfield, Illinois, United States, 62702 | |
| Contact: Cathy L. Clausen, MD 765-646-8358 | |
| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Jeff M. Michalski, MD 314-362-8566 | |
| Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters | Recruiting |
| Saint Peters, Missouri, United States, 63376 | |
| Contact: Jeff M. Michalski, MD 314-362-8566 | |
| United States, Ohio | |
| McDowell Cancer Center at Akron General Medical Center | Recruiting |
| Akron, Ohio, United States, 44307 | |
| Contact: Mitchell L. Fromm, MD 330-344-6448 | |
| Robinson Radiation Oncology | Recruiting |
| Ravenna, Ohio, United States, 44266 | |
| Contact: Mitchell L. Fromm, MD 330-344-6448 | |
| Flower Hospital Cancer Center | Recruiting |
| Sylvania, Ohio, United States, 43560 | |
| Contact: Clinical Trials Office - Flower Hospital Cancer Center 419-824-1842 | |
| United States, Pennsylvania | |
| Kimmel Cancer Center at Thomas Jefferson University - Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107-5541 | |
| Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer 215-955-6084 | |
| United States, Wisconsin | |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Contact: Clinical Trials Office - Vince Lombardi Cancer Clinic 414-649-5717 | |
| West Allis Memorial Hospital | Recruiting |
| West Allis, Wisconsin, United States, 53227 | |
| Contact: Clinical Trials Office - West Allis Memorial Hospital 414-649-5717 | |
| Canada, Alberta | |
| Cross Cancer Institute at University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Nadeem Pervez 780-432-8771 | |
| Canada, British Columbia | |
| British Columbia Cancer Agency - Centre for the Southern Interior | Recruiting |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| Contact: Juanita M. Crook 250-712-3900 | |
| Canada, Ontario | |
| Odette Cancer Centre at Sunnybrook | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Gerard Morton 416-480-6165 | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Saibishkumar E. Parameswaran 416-946-2811 | |
| Study Chair: | Juanita M. Crook, MD | British Columbia Cancer Agency |
More Information
Additional Information:
No publications provided
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00450411 History of Changes |
| Other Study ID Numbers: | CDR0000533887, RTOG-0526 |
| Study First Received: | March 20, 2007 |
| Last Updated: | September 27, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer |
Additional relevant MeSH terms:
|
Adenocarcinoma Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male |
Prostatic Diseases Iodine Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013