Clinical trial · Interventional
Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer (RAD 1203)
RAD 1203: Pilot Trial Evaluating Stereotactic Body Radiotherapy With Integrated Boost for Clinically Localized Prostate Cancer
NCT01856855CI-TRIAL-00063187completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will investigate the safety, tolerability, and effectiveness of giving a higher dose to the part of the prostate which contains the cancer while giving a standard radiation dose to the entire prostate. The investigators have hypothesized that this treatment technique will effectively control the prostate cancer while minimizing the side effects.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Toxicity | — | UNRESOLVED | — |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Body Radiation Therapy with Integrated Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiation Therapy with Integrated Boost
- interventionNames
- Radiation: Stereotactic Body Radiation Therapy with Integrated Boost
Primary outcomes (1)
- measure
- Number of Patients Who Experienced Early Toxicity of SBRT With Integrated Boost for Localized Prostate Cancer
- timeFrame
- Within 3 months of the completion of radiation therapy
- description
- Early toxicity (defined as events occurring within 90 days of therapy) will be assessed by physician history and physical exams and patient toxicity/quality-of-life questionnaires to be administered at regular intervals.
Secondary outcomes (4)
- measure
- Treatment Planning Feasibility
- timeFrame
- Within 6 months of completion of radiation therapy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * All patients must have Histologically confirmed prostate adenocarcinoma, with biopsies obtained within twelve months of patient registration * NCCN risk category very low, low, or intermediate risk * Combined Gleason score \<7 * PSA within three months of enrollment \< 20ng/ml * Clinical stage T1a-c N0M0 or clinical stage T2aN0M0 * Life expectancy \> 5 years * Risk of malignant lymph node involvement \< 15% as calculated on Partin tables * Karnofsky performance status (KPS) \> 60 * Age \> 19 years * Subjects given written informed consent Exclusion Criteria: * History of inflammatory bowel disease * Prior radical prostate surgery, transurethral resection of the prostate(TURP), or prostate cryotherapy * Patients using immunosuppressive medications or other medications that may increase radiation toxicity such as methotrexate, sirolimus, tacrolimus, or colchicine that are unable to discontinue these medications during SBRT course. Use of corticosteroids are not considered an exclusion criteria. * Platelet count \< 70 * Patients unable to discontinue anti-platelet or anti-coagulant medicine such as clopidogrel, dabigatran, warfarin, or low molecular weight heparin. Use of aspirin is not an exclusion criteria. * Pre-SBRT prostate volume \> 120 cc as estimated by trans-rectal ultrasound at time of prostate biopsy (TRUS biopsy). * Risk of malignant lymph node involvement \> 15% as calculated on Partin tables.
References
Publications (0)
Data not yet available
No reference posted for this study.