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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00450411

Run by

Radiation Therapy Oncology Group

People needed

100

Starts

2007-05-01

Expected to finish

2022-05-20

Last updated by the study team

2022-06-21

Who can join

Age: 18 and older, up to 120. Sex: male. Healthy volunteers: not accepted.

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:
• 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
• 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:
• 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.
• 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
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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