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Adenocarcinoma of the ProstateNCT02163317

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

A study testing stereotactic radiosurgery, magnetic resonance imaging and quality-of-life assessment in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
stereotactic radiosurgery, magnetic resonance imaging and quality-of-life assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
16 Feb 2016to 28 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

Other trials in United States

About this study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
stereotactic radiosurgery, magnetic resonance imaging, quality-of-life assessment, Serum Prostate Antigen Test, Digital Rectal Exam
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • stereotactic radiosurgeryRadiation

    Undergo MRI-guided focal SRS

  • magnetic resonance imagingDevice

    Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

    Undergo staging MRI with contrast

  • quality-of-life assessmentOther

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

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

  • Serum Prostate Antigen TestProcedure or surgery

    Also called PSA, PSA response

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

  • Digital Rectal ExamProcedure or surgery

    Also called DRE

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

  • Expanded Prostate Cancer Index CompositeBehavioural

    Also called EPIC

    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.

Study groups in NCT02163317
Study groupRoleWhat they receive
Treatment (MRI-guided focal SRS)ExperimentalPatients 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 1 year from start of study

  2. 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

    Measured: Up to 1 year from start of study

Secondary outcomes (8)

  1. PSA response

    Number of patients with PSA failure. Failure occurs when the PSA is first noted to be 2 ng/mL or more than the patient's nadir value post radiation therapy completion

    Measured: Up to 2 years from start of study

  2. 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)

    Defined as the first occurrence of worst severity of the adverse event =< 30 days after the completion of radiation therapy. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram.

    Measured: Up to 30 days after the completion of radiation therapy

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

    Defined as the first occurrence of worst severity of the adverse event =< 30 days after the completion of radiation therapy.

    Measured: Up to 2 years from start of study

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

    Defined as the first occurrence of worst severity of adverse event > 180 days after radiation therapy completion. Multivariate analysis will be used, and acute rates of GI toxicity will be reported with dose-volume histogram.

    Measured: Up to 2 years from start of study

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

    Defined as the first occurrence of worst severity of adverse event > 180 days after radiation therapy completion.

    Measured: Up to 2 years from start of study

  6. Number of patients with Disease-free survival

    Defined as From the date of treatment to the date of documentation of disease progression or until the date of death from any cause. Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Also, 95% confidence intervals will be reported. Descriptive reports of Response Evaluation Criteria in Solid Tumors (RECIST) (1.1) and volumetric findings will be provided.

    Measured: Up to 2 years from start of study

  7. Time to local progression

    Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Descriptive reports of RECIST (1.1) and volumetric findings will be provided. Time will be reported in months.

    Measured: Up to 2 years from start of study

  8. Time to distant failure

    Radiographic efficacy will be summarized by calculating Kaplan-Meier curves. Descriptive reports of RECIST (1.1) and volumetric findings will be provided. Time will be reported in months.

    Measured: Up to 2 years from start of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2014 (estimated)
  2. Study start16 Feb 2016
  3. Primary completion28 Jul 2021
  4. Study completion28 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02163317
Sponsor's protocol ID
CASE11813
Other IDs
NCI-2014-01170
Status last verified
May 2024
First submitted
11 Jun 2014
Last updated
10 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34604088

Questions about this trial

What is this clinical trial studying?

A study testing stereotactic radiosurgery, magnetic resonance imaging and quality-of-life assessment in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with change in EPIC bowel domain score that was worse than 5 points (time frame: Up to 1 year from start of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02163317, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.

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