Clinical trial · Interventional
Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer
A Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer (SBRT Prostate)
NCT00547339CI-TRIAL-00062536completedPhase 1 / Phase 2Results 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)
RATIONALE: Stereotactic body radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. PURPOSE: This phase I/II trial is studying the side effects and best dose of stereotactic body radiation therapy and to see how well it works in treating patients with prostate cancer.
Conditions
Conditions (1)
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 Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stereotactic body radiation therapy (SBRT)- 45 Gy | Radiation | — | UNRESOLVED |
| stereotactic body radiation therapy (SBRT) - 47.5 Gy | Radiation | — | UNRESOLVED |
| stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 1) | Radiation | — | UNRESOLVED |
| stereotactic body radiation therapy (SBRT) - 50 Gy (Phase 2) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1: Stereotactic Body Radiation Therapy (SBRT) 45 Gy
- description
- The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated - 45 Gy
- interventionNames
- Radiation: stereotactic body radiation therapy (SBRT)- 45 Gy
- type
- EXPERIMENTAL
- label
- Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 47.5 Gy
- description
- The Phase 1 portion of the study will have a 3+3 design. The dose of SBRT is escalated- 47.5 Gy
- interventionNames
- Radiation: stereotactic body radiation therapy (SBRT) - 47.5 Gy
- type
- EXPERIMENTAL
- label
- Phase 1: Stereotactic Body Radiation Therapy (SBRT)- 50 Gy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the prostate
* Stage T1a, T1b, T1c disease
* Stage T2a or T2b
* No direct evidence of regional or distant metastases
* No T2c, T3, or T4 tumors
* Gleason score ≤ 7
* Must meet the following criteria:
* Prostate-specific antigen (PSA) ≤ 20 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 2-6
* PSA ≤ 15 ng/mL prior to starting hormonal therapy (if given) for patients with a Gleason score of 7
* Risk of pelvic lymph node involvement \< 20% according to Roach formula
* Ultrasound-based volume estimation of the prostate gland ≤ 60 g
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-2
* Fertile patients must use effective contraception
* No prior invasive malignancy, except for nonmelanoma skin cancer, unless disease-free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are allowed)
* No significant urinary obstructive symptoms
* American Urological Association (AUA) score of ≤ 15 (alpha blockers allowed)
* No history of inflammatory colitis (including Crohn disease and ulcerative colitis)
* No history of significant psychiatric illness
* No severe, active comorbidity including any of the following:
* Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
* Transmural myocardial infarction within the past 6 months
* Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* Laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
* AIDS (based on current CDC definition) or other immunocompromising condition
* HIV testing is not required for entry into this protocol
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 9 months since prior hormonal therapy as neoadjuvant therapy or to downsize the prostate gland
* No prior pelvic radiotherapy
* No prior chemotherapy or surgery for prostate cancer
* No prior transurethral resection of the prostate (TURP) or cryotherapy to the prostate
* No plans for other concurrent post-treatment, adjuvant, antineoplastic therapy including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy as part of the treatment for prostate cancerReferences
Publications (0)
Data not yet available
No reference posted for this study.