Clinical trial · Interventional
Stereotactic Body Radiation Therapy With Boost Using Urethral-Sparing Intensity-Modulated Radiation Therapy Planning in Treating Patients With Prostate Cancer
A Phase I/II Study of Stereotactic Body Radiotherapy (SBRT) for Prostate Cancer Using Simultaneous Integrated Boost and Urethral-Sparing IMRT Planning
- 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 phase I/II trial studies the side effects and best dose of stereotactic body radiation therapy while using intensity-modulated radiation therapy (IMRT) planning to help avoid radiation to normal tissue in patients with prostate cancer. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using small, high doses of radiation over several days and may cause less damage to normal tissue. This treatment schedule allows for a higher dose of radiation to be administered over a shorter overall treatment period in comparison to standard radiation therapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage II Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
| Stage I Prostate Adenocarcinoma | Prostate Adenocarcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy Treatment Planning and Simulation | Radiation | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (moderate dose SBRT with SIB)
- description
- Patients undergo 5 fractions of moderate dose SBRT with SIB every other day for 10 days following urethral-sparing IMRT planning. SBRT: 8.0Gy escalated dose
- interventionNames
- Radiation: Radiation Therapy Treatment Planning and Simulation
- Radiation: SBRT
- type
- ACTIVE_COMPARATOR
- label
- Arm B (uniform dose SBRT)
- description
- Patients undergo 5 fractions of uniform dose SBRT every other day for 10 days following urethral-sparing IMRT planning. SBRT: 7.5Gy conventional dose
- interventionNames
- Radiation: Radiation Therapy Treatment Planning and Simulation
- Radiation: SBRT
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed diagnosis of adenocarcinoma of the prostate and most recent biopsy within 180 days of study enrollment * History/physical examination with digital rectal examination of the prostate within 90 days prior to study enrollment * Gleason score =\< 7, no tertiary pattern \>= 5 * Clinical stage =\< T2b (American Joint Committee on Cancer \[AJCC\] 7th Edition Staging Manual) and no radiographic evidence of T3 or T4 disease * Clinical stage N0, M0 * Most recent prostate specific antigen (PSA) within 60 days of enrollment * Maximum PSA =\< 20 ng/ml (not within 20 days after biopsy) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * American Urological Association (AUA) =\< 18 with or without medical management * Up to a total of year of androgen deprivation allowed. * Participant signs study specific informed consent prior to study enrollment Exclusion Criteria: * FOR ARM A: Inability to obtain a planning MRI or a planning MRI of sufficient quality to allow identification of the peripheral zone and urethra, or inability to adequately fuse the MRI to the planning CT scan * FOR BOTH ARM A AND ARM B: * Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years; (for example, carcinoma in situ of the bladder or oral cavity is permissible) * Prosthetic implants in the pelvic region that the investigator feels will impede treatment, planning, or delivery (e.g., an artificial hip) * =\< 3 months from a transurethral resection of the prostate (TURP) procedure * Significant urinary obstruction (i.e. AUA symptom score \> 18) * Previous pelvic irradiation, prostate brachytherapy * Previous radical surgery (prostatectomy) or cryosurgery for prostate cancer * Severe, active comorbidity, defined as follows: * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Crohn's disease or ulcerative colitis * Scleroderma
References
Publications (0)
Data not yet available