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Stereotactic Body Radiation Therapy in Treating Patients With Localized Prostate Cancer That Have Undergone Surgery

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ClinicalTrials.gov Identifier: NCT03541850
Recruitment Status : Recruiting
First Posted : May 31, 2018
Last Update Posted : December 8, 2020
Sponsor:
Collaborator:
Viewray Inc.
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Brief Summary:
This phase II trial studies how well stereotactic body radiation therapy works in treating patients with prostate cancer that has not spread to other parts of the body and have undergone surgery. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

Condition or disease Intervention/treatment Phase
PSA Level Greater Than 0.03 PSA Progression Stage I Prostate Adenocarcinoma AJCC (American Joint Committee on Cancer ) v7 Stage II Prostate Adenocarcinoma AJCC v7 Stage III Prostate Adenocarcinoma AJCC v7 Drug: Antiandrogen Therapy Other: Quality-of-Life Assessment Radiation: Stereotactic Body Radiation Therapy Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the efficacy of postoperative stereotactic body radiation therapy (SBRT) at a dose of 34 grays (Gy) in five fractions, as compared with historical control efficacy rates in patients who received conventionally fractionated postoperative radiotherapy.

II. To determine the toxicity of postoperative SBRT at a dose of 34 Gy in five fractions, both via physician-scored and patient-reported metrics.

SECONDARY OBJECTIVES:

I. To determine the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with magnetic resonance imaging (MRI)-guided radiotherapy.

II. To gather biomarkers that may elucidate predictors of increased efficacy or increased toxicity.

TERTIARY OBJECTIVES:

I. To compare toxicity profiles (both physician-scored and patient-reported) between patients treated utilizing a linear accelerator versus a tri-60Co teletherapy platform.

OUTLINE:

Patients undergo SBRT every other day (QOD) for 14 days. Patients may also receive androgen deprivation therapy (ADT) comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.

After completion of study treatment, patients are followed up at 1 month, every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Study of Stereotactic Body Radiotherapy (SBRT) Following Radical Prostatectomy
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (SBRT, ADT)
Patients undergo SBRT QOD for 14 days. Patients may also receive ADT comprised of a luteinizing hormone-releasing hormone agonist or a gonadotropin-releasing hormone antagonist, and an oral anti-androgen for 6 months at the discretion of the treating physician.
Drug: Antiandrogen Therapy
Receive luteinizing hormone-releasing hormone agonist or gonadotropin-releasing hormone antagonist, and oral anti-androgen
Other Names:
  • ADT
  • Androgen Deprivation Therapy
  • Anti-androgen Therapy
  • Anti-androgen Treatment
  • Antiandrogen Treatment
  • Hormone Deprivation Therapy
  • Hormone-Deprivation Therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Radiation: Stereotactic Body Radiation Therapy
Undergo SBRT
Other Names:
  • SABR
  • SBRT
  • Stereotactic Ablative Body Radiation Therapy




Primary Outcome Measures :
  1. Biochemical recurrence-free survival (BCRFS) [ Time Frame: Up to 5 years ]
    Defined as serum prostate-specific antigen (PSA) rising from the post-treatment nadir to a level of 0.2 ng/mL or more with a confirmatory second test, initiation of salvage androgen deprivation therapy, or continued rise in PSA after stereotactic body radiation therapy (SBRT). The Kaplan-Meier product-limit estimate of the BCRFS will be estimated and presented graphically. One sample log-rank test will be used to test difference in BCRFS between intervention and historical control. The median BCRFS time will be calculated with 95% confidence interval. Summaries of the number and percentage of patients experiencing a biochemical recurrence will be provided.

  2. Physician-scored toxicity [ Time Frame: Up to 5 years ]
    Represented by the rates of acute (early, within 90 days of SBRT) and late (90 or more days after SBRT) genitourinary and gastrointestinal toxicity based on the Common Terminology Criteria for Adverse Events version 4.03. Adverse Events (AEs) and serious adverse events (SAEs) will be listed individually by patient.

  3. Patient-reported toxicity outcomes EPIC-26 [ Time Frame: Up to 5 years ]
    Patient-reported toxicity outcomes represented by changes in the urinary incontinence, urinary obstruction, bowel, sexual function, and hormone/vitality domains on the Expanded Prostate Cancer Index-26 (EPIC-26) quality of life instrument (scored from 0-100 points for each domain, higher scores reflect worse symptom/bother severity.)

  4. Patient-reported toxicity outcomes IPSS [ Time Frame: Up to 5 years ]
    Patient-reported toxicity outcomes represented by changes in International Prostate Symptom Scores (IPSS) (scored from 0-35 points, higher scores reflect worse symptom/bother severity.).


Secondary Outcome Measures :
  1. Proportion of stereotactic body radiation therapy (SBRT) fractions for which on-line adaptive radiotherapy was utilized in the subset of patient treated with magnetic resonance imaging (MRI)-guided radiotherapy [ Time Frame: Up to 5 years ]
    Point estimate and the corresponding 95% confidence interval will be calculated for the proportion of SBRT fractions for which on-line adaptive radiotherapy is required due to changes in organ-at-risk anatomy, in the subset of patients treated with MRI-guided radiotherapy.


Other Outcome Measures:
  1. Physician-scored Toxicity profiles patients treated utilizing a linear accelerator [ Time Frame: Up to 5 years ]
    Comparative analysis will be performed to assess physician-scored toxicity profiles for treated utilizing a linear accelerator. Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

  2. Patient-reported toxicity outcomes; patients treated utilizing a linear accelerator [ Time Frame: Up to 5 years ]
    Comparative analysis will be performed to assess patient-reported toxicity profiles for treated utilizing a linear accelerator. Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

  3. Physician-scored toxicity profiles patients treated utilizing the magnetic resonance imaging (MRI)-guided device [ Time Frame: Up to 5 years ]
    Comparative analysis will be performed to assess toxicity profiles with patients treated utilizing a linear accelerator. Chi-square test or Fisher's exact test will be used for qualitative toxicity measurements, while unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.

  4. Patient-reported toxicity profiles patients treated utilizing the magnetic resonance imaging (MRI)-guided device [ Time Frame: Up to 5 years ]
    Comparative analysis will be performed to assess patient-reported toxicity profiles for treated utilizing an MRI-guided radiotherapy device. Unpaired t-test or Wilcoxon rank sum test will be used for quantitative toxicity metrics.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of histologically confirmed, clinical localized adenocarcinoma of the prostate treated with radical prostatectomy with definitive intent
  • Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic T-stage 3-4 disease, pathologic Gleason score 8-10 disease, presence of tertiary Gleason grade 5 disease) OR documentation of rising prostate-specific antigen on at least two consecutive draws, with the magnitude of prostate-specific antigen exceeding 0.03 ng/mL
  • Computed tomography (CT) scan and MRI of the pelvis within 120 days prior to enrollment (note: [a] if patient has medical contraindication to MRI, an exemption will be granted and enrollment can proceed [b] for patients with PSA < 1.0 ng/mL, the treatment planning CT can substitute for a diagnostic CT scan)
  • Bone scan within 120 days prior to enrollment; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis, and advanced imaging (e.g., 18NaF positron emission tomography [PET]/CT) is strongly recommended
  • Karnofsky performance score (KPS) >= 70
  • Ability to understand, and willingness to sign, the written informed consent

Exclusion Criteria:

  • Patients with any evidence of distant metastases
  • Patients with pathologically-confirmed N1 prostate cancer
  • Patients with neuroendocrine or small cell carcinoma of the prostate
  • Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate
  • Prior pelvic radiotherapy
  • History of Crohn's disease, ulcerative colitis, or ataxia telangiectasia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03541850


Contacts
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Contact: Amar Kishan, MD 310-825-9771 aukishan@mednet.ucla.edu
Contact: Vince Basehart 310-267-8954 vbasehart@mednet.ucla.edu

Locations
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United States, California
USC Norris Comprehensive Cancer Center and Hospital Recruiting
Los Angeles, California, United States, 90033
Contact: Leslie Ballas, MD    323-865-3050    lballas@med.usc.edu   
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Amar Kishan, MD    310-825-9775    aukishan@mednet.ucla.edu   
Principal Investigator: Amar Kishan, MD         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Viewray Inc.
Investigators
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Principal Investigator: Amar Kishan, MD UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03541850    
Other Study ID Numbers: 17-001064
NCI-2017-02032 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
17-001064 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Ascorbic Acid
Methyltestosterone
Hormones
Estrogens, Conjugated (USP)
Androgens
Androgen Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Estrogens
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Hormone Antagonists