Clinical trial NCT02163317: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer
Official title: Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. Evaluate the correlation of histopathology findings in comparison to regions of the prostate reported to be suspicious for harboring tumor burden on multiparametric MRI report/s.

II. Demonstration of the dosimetric and radiobiological advantages of focal stereotactic body radiation therapy (SBRT) versus whole-gland radiation therapy.

III. Evaluation of clinical outcomes in focal SBRT for localized prostate cancer.

OUTLINE:

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.

After completion of study treatment, patients are followed up every 3 months for up to 24 months.

Eligibility criteria: 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

Primary outcomes:
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
measure: Number of patients with change in EPIC urinary domain score that was worse than 2 points
timeFrame: Up to 1 year from start of study
Secondary outcomes:
measure: PSA response
timeFrame: Up to 2 years from start of study
measure: Number of acute gastrointestinal (GI) grade 3+ acute adverse events, evaluated by the Cancer Therapy Evaluation Program (CTEP) active version of the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
timeFrame: Up to 30 days after the completion of radiation therapy
measure: Number of acute genitourinary (GU) grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE
timeFrame: Up to 2 years from start of study
measure: Number of late GI grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE
timeFrame: Up to 2 years from start of study
measure: Number of late GU grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE
timeFrame: Up to 2 years from start of study
measure: Number of patients with Disease-free survival
timeFrame: Up to 2 years from start of study
measure: Time to local progression
timeFrame: Up to 2 years from start of study
measure: Time to distant failure
timeFrame: Up to 2 years from start of study
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Elisha Fredman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fredman 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.