Clinical trial · Interventional
Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer
A Phase II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Continuous Real-time Evaluation of Prostate Motion and IMRT Plan Reoptimization Based on the Anatomy of the Day
NCT00941915CI-TRIAL-00056107SMARTcompletedN/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)
The purpose of this study is to evaluate the incidence of urinary and gastrointestinal acute and late side effects in patients treated with stereotactic body radiotherapy (SBRT) to the prostate. Stereotactic radiation therapy is given as five treatments over a 2-3 week period. The prostate is localized and the plan is reoptimized as needed prior to each treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SBRT Prostate | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Radiotherapy
- description
- Five fractions of 7.4 Gy each
- interventionNames
- Radiation: SBRT Prostate
Primary outcomes (4)
- measure
- Number of Participants With Genitourinary Acute Toxicity
- timeFrame
- </= 90 days post radiation treatment, a total of 90 days
- description
- Genitourinary Acute Toxicity is defined as Grade 3 or higher occurring within 90 days from the end of radiation treatment
- measure
- Number of Participants With Genitourinary Late Toxicity
- timeFrame
- >90 days from the end of treatment, up to 3 years
- description
- Genitourinary Late Toxicity is defined as Grade 3 or higher occurring \>90 days from the end of radiation treatment
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 82 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the prostate within 365 days of study enrollment * History/physical examination with digital rectal examination of the prostate within 8 weeks prior to study enrollment * Gleason score less than or equal to 7 * Clinical Stage T1-T2c * PSA * less than or = 15 ng/ml prior to start of therapy if Gleason \< or = 6 or * less than or = 10 ng/ml prior to start of therapy if Gleason = 7 * Zubrod Performance Status 0-1 * Age \> 40 Exclusion Criteria: * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. (Carcinoma in situ of the bladder or oral cavity is permissible) * Evidence of distant metastases * Regional lymph node involvement * Significant urinary obstruction * Estimated prostate gland \> 100 grams * Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * Previous hormonal therapy, such as LHRH agonists (e.g. goserelin, leuprolide), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or surgical castration (bilateral orchiectomy) or planned concurrent androgen deprivation therapy * Previous or concurrent cytotoxic chemotherapy for prostate cancer * Prosthetic implants in the pelvic region that contain metal or conductive materials (e.g., an artificial hip). * Severe, active comorbidity
References
Publications (4)
- BACKGROUNDPeeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, Bonfrer JM, Incrocci L, Lebesque JV. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006 May 1;24(13):1990-6. doi: 10.1200/JCO.2005.05.2530. PMID 16648499
- BACKGROUNDZietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233. PMID 16160131
- BACKGROUNDMadsen BL, Hsi RA, Pham HT, Fowler JF, Esagui L, Corman J. Stereotactic hypofractionated accurate radiotherapy of the prostate (SHARP), 33.5 Gy in five fractions for localized disease: first clinical trial results. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1099-105. doi: 10.1016/j.ijrobp.2006.10.050. PMID 17336216
- RESULTBoyer MJ, Papagikos MA, Kiteley R, Vujaskovic Z, Wu J, Lee WR. Toxicity and quality of life report of a phase II study of stereotactic body radiotherapy (SBRT) for low and intermediate risk prostate cancer. Radiat Oncol. 2017 Jan 13;12(1):14. doi: 10.1186/s13014-016-0758-8. PMID 28086825