Magnetic Resonance Guided Focal Stereotactic Body Radiation Therapy for Localized Prostate Cancer

NCT02163317 | Completed DMC

• 2 other identifiers: CASE11813NCI-2014-01170
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Number of patients with change in EPIC bowel domain score that was worse than 5 points

  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

  Up to 1 year from start of study

• Number of patients with change in EPIC urinary domain score that was worse than 2 points

  Number of patients with change in EPIC urinary domain score that was worse than 2 points A rate for the worse-than-2 point change in urinary score of up to 40% will be considered acceptable, with a rate ≥60% unacceptable

  Up to 1 year from start of study

Secondary Outcomes (8)

• PSA response

  Up to 2 years from start of study

• 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)

  Up to 30 days after the completion of radiation therapy

• Number of acute genitourinary (GU) grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE

  Up to 2 years from start of study

• Number of late GI grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE

  Up to 2 years from start of study

• Number of late GU grade 3+ acute adverse events, evaluated by the CTEP version of the NCI CTCAE

  Up to 2 years from start of study

Study Arms (1)

Treatment (MRI-guided focal SRS)

EXPERIMENTAL

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.

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

Interventions

stereotactic radiosurgery RADIATION

Undergo MRI-guided focal SRS

Treatment (MRI-guided focal SRS)

magnetic resonance imaging DEVICE

Undergo staging MRI with contrast

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Treatment (MRI-guided focal SRS)

quality-of-life assessment OTHER

Quality of life scores will be summarized graphically and repeated measures of variance will be conducted to test for changes in scores over time

Also known as: quality of life assessment, International Prostate Symptom Score / Sexual Health Inventory for Men (IPSS/SHIM) QoL Scores, Health related quality of life (HRQOL)

Treatment (MRI-guided focal SRS)

Serum Prostate Antigen Test PROCEDURE

Test of the PSA protein in blood. The test will be run every three months for up to two years during the study.

Also known as: PSA, PSA response

Treatment (MRI-guided focal SRS)

Digital Rectal Exam PROCEDURE

Exam of rectal health. Performed every three months for up to two years throughout the study.

Also known as: DRE

Treatment (MRI-guided focal SRS)

Expanded Prostate Cancer Index Composite BEHAVIORAL

This survey measures a patient's function and bother after prostate cancer treatment. It will be analyzed using ANOVA using data collected every 6 months for up to 2 years of the study.

Also known as: EPIC

Treatment (MRI-guided focal SRS)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

• 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.

  PMID: 34604088 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery; Magnetic Resonance Imaging; Menogaril; Quality of Life

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Nogalamycin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Elisha Fredman, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: February 16, 2016
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

US (1)