Phase 2
N=100
Ultrasound-Guided Implant Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer Previously Treated With External-Beam Radiation Therapy
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00450411 ↗Enrolled (actual)
100
Serious AEs
8.7%
Results posted
Nov 2017
Primary outcome: Primary: Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) — 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 125-Iodine (Radiation); 103-palladium (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Radiation Therapy Oncology Group
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Late Treatment-related Gastrointestinal (GI) and Genitourinary (GU) Adverse Events (AE) |
12 | — |
| SECONDARY Number of Patients With Acute Treatment-related GI and GU Adverse Events |
12 | — |
| SECONDARY Percentage of Participants Alive at 5 Years (Overall Survival) |
92.2 | — |
| SECONDARY Percentage of Participants Alive Without Disease (Disease-free Survival) |
61.2 | — |
| SECONDARY Percentage of Participants With Prostate Cancer Death at 5 Years (Disease-specific Survival) |
92.2 | — |
| SECONDARY Percentage of Participants With Local Failure at 5 Years |
3.3 | — |
| SECONDARY Percentage of Participants With Distant Failure at 5 Years |
10.0 | — |
| SECONDARY Percentage of Participants With Biochemical Failure at 4 Years |
32.2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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) 8 months, evidence of a normal serum testosterone must be documented.
Data sourced from ClinicalTrials.gov (NCT00450411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.