N/A
N=23
Internal Radiation Therapy in Treating Patients With Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00573833 ↗Enrolled (actual)
23
Serious AEs
9.5%
Results posted
Oct 2017
Primary outcome: Primary: Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity — 20 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- questionnaire administration (Other); quality-of-life assessment (Procedure); brachytherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With an Acceptable Level of Severe Toxicity as Defined at < Grade 3 CTC Toxicity |
20 | — |
| PRIMARY Number of Patients With an Acceptable Level of Treatment Related Urinary and Rectal Toxicity as Defined at < Grade 3 CTC Toxicity |
21 | — |
Summary
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects and how well internal radiation therapy works in treating patients with prostate cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Inclusion criteria
- Intermediate-risk adenocarcinoma of the prostate, defined by 1of the following criteria:
- PSA 10-20 ng/mL
- Gleason score ≥ 7
- Stage ≥ T2b AND 20 ng/mL
- Presence of distant metastases
PATIENT CHARACTERISTICS:
- WBC ≥ 3,500/mm³
- Platelet count ≥ 75,000/mm³
- Hemoglobin ≥ 10 g/dL
- Creatinine ≤ 1.5 mg/dL
- Liver function tests ≤ 1.5 times normal
- INR ≤ 2.5
- Able to complete quality of life questionnaires
- Able to give informed consent
- No active perineal infections
- No history of urethral stricture
- No prior history of pelvic malignancy
- No prior history of lymphoma disease, ulcerative colitis, or anal fissures
- No contraindications to general anesthesia
- No pacemaker
PRIOR CONCURRENT THERAPY:
- No prior transurethral resection of the prostate
- No prior pelvic radiotherapy
- No prior treatment for prostate cancer except for hormone therapy
Data sourced from ClinicalTrials.gov (NCT00573833). 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.