Clinical trial · Interventional
Stereotactic Body Radiotherapy (SBRT) With Concurrent Boost for Low- and Intermediate-Risk Prostate Cancer
A Prospective Protocol of Stereotactic Body Irradiation With Concurrent Intraprostatic Lesion Boost Utilizing Intensity Modulated Radiotherapy for Patients With Low- and Intermediate-Risk Prostate Cancer
NCT01409473CI-TRIAL-00013739Prostate SBRTwithdrawnPhase 2ClinicalTrials.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 determine whether stereotactic body radiation therapy (SBRT) with simultaneous boost (higher radiation dose) to areas within the prostate with more prominent cancerous growth (intraprostatic lesions) utilizing intensity modulated radiotherapy (IMRT) planning techniques is a safe and effective treatment in patients with low- and intermediate-risk localized 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate SBRT with concurrent boost to intraprostatic lesion(s) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate SBRT
- description
- Prostate SBRT with concurrent boost to intraprostatic lesion (IPL) will be delivered in 5 fractions using intensity-modulated radiotherapy planning techniques.
- interventionNames
- Radiation: Prostate SBRT with concurrent boost to intraprostatic lesion(s)
Primary outcomes (1)
- measure
- Biochemical disease-free survival
- timeFrame
- 5-8 years
- description
- Biochemical Disease-Free Survival (bDFS), the time from completion of protocol treatment to the documented PSA rise of 2 ng/mL above the PSA nadir reached after treatment.
Secondary outcomes (8)
- measure
- Grade 2 or higher acute gastrointestinal, genitourinary, and erectile toxicities
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven diagnosis of prostate adenocarcinoma within one year * Gleason Score 2-7 * Clinical T-stage T1b-T2c (AJCC 7th Edition) * Clinical Nx or N0, and Mx or M0 * PSA \< 20 ng/mL * Low or intermediate risk according to NCCN guidelines: Low: Clinical Stage (CS) T1b-T2a and Gleason 2-6 and PSA \< 10 ng/ml; Intermediate: CS T2b-T2c and Gleason 2-6 and PSA \< 10 ng/ml, or CS T1b-T2a and Gleason 7 and PSA \< 10 ng/ml, or CS T1b-T2a and Gleason 2-6 and PSA 10-20ng/mL * ECOG performance status 0 or 1 * Has had a pre-treatment PSA drawn within a month of the beginning of protocol therapy * If androgen-deprivation therapy (ADT) has been initiated, must have a documented pre-ADT PSA; this baseline PSA should not be obtained during following periods: 1) 10-day period following prostate biopsy; 2) within 30 days after discontinuation of finasteride; or 3) within 90 days after discontinuation of dutasteride. * Has completed a baseline health-related quality of life assessment Extended Prostate Cancer Index Composite questionnaire (EPIC-26) * Has had a history and physical examination (including digital rectal examination and a formal morbidity assessment via the ACE-27) within 60 days * Morbidity score (via the ACE-27) of none (0), mild (1) or moderate (2) * Willing and able to use adequate contraception during protocol treatment and for 3 months after the completion of protocol treatment Exclusion Criteria: * Invasive (carcinoma in situ is allowed) solid or hematologic malignancy (other than this prostate cancer, or basal or squamous skin cancers) in the last 5 years * Prior prostatectomy or cryotherapy of the prostate * Prior radiotherapy to the prostate or lower pelvis * Prior or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for a different cancer is allowed) * Implanted hardware near the planning target volume that would prohibit appropriate treatment planning or treatment delivery in the investigator's opinion
References
Publications (0)
Data not yet available
No reference posted for this study.