At a glance
ClinicalIndex Comparison Record- ✓Biopsy-documented locally recurrent prostate adenocarcinoma ≥30 months after completion of EBRT, biopsied ≤180 days prior to registration
- ✓Initial disease at diagnosis (prior to EBRT): stage T1–T2c, Gleason 2–7, PSA ≤20 ng/mL
- ✓Negative lymph nodes by imaging (CT/MRI) or dissection, and no bone metastases on bone scan
- ✓Baseline PSA <10 ng/mL within 8 weeks prior to registration using FDA-approved assay
- ✕Prior invasive or hematological malignancy unless disease-free ≥3 years (low-grade lymphoma and CLL allowed)
- ✕Prior EBRT dose to prostate ≥78 Gy (2 Gy fractions), ≥79.8 Gy (1.9 Gy fractions), or ≥81 Gy (1.8 Gy fractions)
- ✕Baseline GI or GU toxicity grade ≥2 (CTCAE v3.0)
- ✕Severe active comorbidity: unstable angina, decompensated heart failure, MI within 6 months, active infection, COPD exacerbation/respiratory illness requiring hospitalization, hepatic insufficiency with jaundice/coagulation defects, or AIDS
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Phase II Trial of Transperineal Ultrasound-Guided Brachytherapy for Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
In Brief
A Phase 2 clinical trial evaluating 125-Iodine and 103-palladium for Prostate Cancer. Completed, enrolled 100 participants across 17 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Brachytherapy to the prostate via 125-iodine (I-125) seeds with a planned dose of 140 Gy
Brachytherapy to the prostate via 103-palladium (Pd-103) seeds with a planned dose of 120 Gy