Clinical trial · Interventional
Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer
NCT02163317CI-TRIAL-00077034completedN/AClinicalTrials.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 pilot clinical trial studies magnetic resonance (MRI)-guided focal stereotactic radiosurgery (SRS) in treating patients with low- or intermediate-risk localized prostate cancer. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Rectal Exam | Procedure | — | UNRESOLVED |
| Expanded Prostate Cancer Index Composite | Behavioral | — | UNRESOLVED |
| magnetic resonance imaging | Device | — | UNRESOLVED |
| quality-of-life assessment | Other | — | UNRESOLVED |
| Serum Prostate Antigen Test | Procedure | — | UNRESOLVED |
| stereotactic radiosurgery | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (MRI-guided focal SRS)
- description
- Patients undergo 3 fractions of MRI-guided focal SRS every other day for 1 week. Patients undergo additional MRI scans between the 2nd and 3rd fractionated treatments, at 6 months following the end of radiation therapy, and at 12 and 24 months.
- interventionNames
- Radiation: stereotactic radiosurgery
- Device: magnetic resonance imaging
- Other: quality-of-life assessment
- Procedure: Serum Prostate Antigen Test
- Procedure: Digital Rectal Exam
- Behavioral: Expanded Prostate Cancer Index Composite
Primary outcomes (2)
- measure
- Number of patients with change in EPIC bowel domain score that was worse than 5 points
- timeFrame
- Up to 1 year from start of study
- description
- Number of patients with change in EPIC bowel domain score that was worse than 5 points A rate for the worse-than-5 point change in bowel score of up to 35% of patients will be considered acceptable, with a rate ≥55% specified as unacceptable
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a histologically confirmed diagnosis of adenocarcinoma of the prostate * Patient must have a history/physical examination with digital rectal examination of the prostate within 90 days prior to screening * Eastern Cooperative Oncology Group (ECOG) performance status must be level 0 or 1 within 60 days prior to registration * Patient must have a histological evaluation of the prostate biopsy with assignment of a Gleason score to the biopsy material; Gleason scores ≤ 7(3+4) * Serum creatinine ≤ 1.5 times upper limit of institutional normal (normal: ≤ 1.17 mL/min/1.73 m\^2) * Clinical stage a ≤ T1-T2a (American Joint Committee on Cancer \[AJCC\] 7th edition) * Prostate specific antigen (PSA) ≤ 10 ng/mL within 90 days prior to registration; PSA should not be obtained within 10 days after prostate biopsy * Subjects must have the ability to understand and the willingness to sign a written informed consent document * Patient willing and able to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire (baseline, 6, 12 and 24 months post end of radiation therapy) * Patients must be able to undergo an MRI with contrast * Bone scan completed within 90 days Exclusion Criteria: * Evidence of distant metastases * Regional lymph node involvement * Previous radical surgery (prostatectomy), cryosurgery, or high intensity focused ultrasound (HIFU) for prostate cancer * Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * Previous hormonal therapy, such as luteinizing hormone-releasing hormone (LHRH) agonists (e.g., goserelin, leuprolide) or LHRH antagonists (e.g., degarelix), anti-androgens (e.g., flutamide, bicalutamide), estrogens (e.g., diethylstilbestrol \[DES\]), or surgical castration (orchiectomy) * Use of finasteride within 30 days prior to registration; PSA should not be obtained prior to 30 days after stopping finasteride * Use of dutasteride within 90 days prior to registration; PSA should not be obtained prior to 90 days after stopping dutasteride * Previous or concurrent cytotoxic chemotherapy for prostate cancer * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 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 at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol; (patients on Coumadin or other blood thinning agents are eligible for this study) * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease and Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol; protocol-specific requirements may also exclude immuno-compromised patients * Patients unable to undergo an MRI with contrast
References
Publications (1)
- DERIVEDFredman E, Traughber B, Kharouta M, Podder T, Lo S, Ponsky L, MacLennan G, Paspulati R, Ellis B, Machtay M, Ellis R. Focal Prostate Stereotactic Body Radiation Therapy With Correlative Pathological and Radiographic-Based Treatment Planning. Front Oncol. 2021 Sep 15;11:744130. doi: 10.3389/fonc.2021.744130. eCollection 2021. PMID 34604088