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Stereotactic Body Radiation Therapy for Low and Intermediate Risk Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554369
Recruitment Status : Active, not recruiting
First Posted : June 13, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief Summary:

There are two separate phases of this study. The purpose of the phase-I is to initially find a potent but reasonably safe dose of a stereotactic body radiation therapy (SBRT) for treating prostate cancer. Once this potent but reasonably safe dose is found, the phase-II will treat additional patients with SBRT to see what effects (good and bad) it has on prostate cancer.

Phase-I

  • Primary objective: To escalate the dose of stereotactic radiotherapy to a tumorcidal dose without exceeding the maximum tolerated dose in patients with organ confined prostate cancer.
  • Secondary objective: To determine the dose limiting toxicity (DLT) (if the maximum tolerated dose is reached)

Phase-II

  • Primary objective: To determine the late severe grade 3-5 Gu and Gi toxicity at nine months from the start of the protocol treatment (graded base on the CTCae v3.0)
  • Secondary objective: To determine the 2 year biochemical Prostate Specific Antigen (PSA) control (freedom from PSA failure), disease free and overall survival, local control, freedom from distant metastases, and the incidence of high grade adverse events of any type from the therapy in the treated patients in order to determine if the therapy is promising enough for further clinical investigation.

Condition or disease Intervention/treatment Phase
Adenocarcinoma of the Prostate Radiation: Prostate SBRT Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I and II Study of Stereotactic Body Radiation Therapy (SBRT) for Low and Intermediate Risk Prostate Cancer
Actual Study Start Date : July 11, 2006
Actual Primary Completion Date : December 20, 2011
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Intervention/Treatment
Prostate SBRT will be delivered in 5 fractions using intensity-modulated radiotherapy planning techniques.
Radiation: Prostate SBRT
Patients will receive 45Gy in 5 fractions of radiation. A minimum of 36 hours and a maximum of 8 days should separate each treatment. No more than 3 fractions will be delivered per week (7 consecutive days). Total dose will depend on the phase of the study




Primary Outcome Measures :
  1. Dose Limiting Toxicity (DLT) [ Time Frame: 1-2 Years ]
    Severity or Toxicity will be graded using the NCI Common Toxicity Criteria for Adverse Events (CTCAE) v. 3.0. A dose- limiting toxicity (DLT) is any treatmentrelated grade 3, 4, or 5 toxicity in the following categories gastrointestinal, renal, genito-urinary, sexual- reproductive, or neurological constitutional symptoms. CTCAE V3.0 along with grades 1-5 is provided in the link for reference (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf).


Secondary Outcome Measures :
  1. Acute & Delayed Genitourinary (GU) and Gastrointestinal (GI) toxicity [ Time Frame: 10 Years ]
    Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 3.0. Dose adjustments should be made according to the system showing the greatest degree of toxicity. The consequences of gastointestinal/renal/genitourinary/sexual and reproductive toxicity should all be graded 1-5 according to the Common Terminology Criteria For Adverse Events (CTCAE), version 3.0 occurring prior to 270 days from the start of protocol treatment. Other treatment related toxicity attributed to the therapy will be captured, recorded and the consequences of should all be graded 1-5 according to the Common Terminology Criteria For Adverse Events (CTCAE). CTCAE V3.0 along with grades 1-5 is provided in the link for reference (https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf).

  2. Biochemical failure RTOG-ASTRO definition (also known as Phoenix definition) [ Time Frame: 10 Years ]
    Increase in PSA greater than 2ng/ml above the patients lowest PSA level (nadir) after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (Male) who satisfy all of the following conditions will be eligible for this study:

    • All patients must be willing and capable to provide informed consent to participate in the protocol
    • Eligible patients must have appropriate staging studies identifying them as American Joint Committee on Cancer (AJCC) stage T1 (a, b, or c) or T2 (a and b only) adenocarcinoma of the prostate gland. The patient should not have direct evidence of regional or distant metastases after appropriate staging studies. Histologic confirmation of cancer will be required by biopsy
    • The patient's Zubrod performance status must be 0-2
    • The Gleason score should be less than or equal to 7
    • The serum PSA should be less than or equal to 20 ng/ml prior to starting hormonal therapy (if given) for patients with Gleason score 2-6. For patients with Gleason score of 7, PSA should be less than or equal to 15 ng/ml prior to starting hormonal therapy (if given). As such, the risk of pelvic lymph node involvement according to the Roach formula would be under 20%
    • Patients may have used prior hormonal therapy, but it should be limited to no more than 9 months or therapy prior to enrollment
    • Patients should not have significant urinary obstructive symptoms; American Urological Association (AUA) score must be ≤ 15 (alpha blockers allowed)
    • The ultrasound or CT based volume estimation of the patient's prostate gland should not be greater than 60 grams
    • Male of reproductive potential may not participate unless they agreed that they or their partner use an effective contraceptive method such as condom/diaphragm and spermacidal foam, intrauterine device (IUD), or prescription birth control pills

Exclusion Criteria:

  • Patients (Female) are not eligible for this study. Patients (Male) with one or more of the following conditions also are ineligible for this study:

    • Positive lymph nodes or metastatic disease from prostate cancer
    • Prior invasive malignancy unless disease free for a minimum of 3 years (carcinoma in situ of the breast, oral cavity, or cervix, or non-melanomatous skin cancer are all permissible)
    • T2c, T3, or T4 tumors
    • Previous pelvic radiotherapy
    • Previous surgery or chemotherapy for prostate cancer
    • Previous transuretheral resection of the prostate (TURP) or cryotherapy to the prostate
    • Previous hormonal therapy given for more than 9 months prior to therapy
    • Concomitant antineoplastic therapy (including surgery, cryotherapy, conventionally fractionated radiotherapy, and chemotherapy) while on this protocol
    • History of Crohn's Disease or Ulcerative Colitis
    • Previous significant obstructive symptoms; American Urological Association (AUA) score must be ≤ 15 (alpha blockers allowed)
    • Significant psychiatric illness
    • Men of reproductive potential may not participate unless they agree to use an effective contraceptive method
    • Ultrasound or CT estimate of prostate volume > 60 grams
    • Severe, active co-morbidity as defined in the following:
    • 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 within 30 days before 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
    • Acquired Immune Deficiency Syndrome (AIDS) based upon current Center for Disease Control and Prevention (CDC) definition; note, however, that Human Immunodeficiency Virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immuno-suppressive. Protocol-specific requirements may also exclude immuno-compromised patients
    • History of treatment with potent immuno-suppressive drugs for such conditions as post organ transplant, severe rheumatoid arthritis, etc. within the past 6 months

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): NCT03554369


Locations
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United States, Texas
UT Southwestern Cancer Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03554369     History of Changes
Other Study ID Numbers: STU 072010-019
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas Southwestern Medical Center:
Prostate
Dose-Limiting Toxicity
Maximum Tolerated Dose
Stereotactic Body Radiation Therapy (SBRT)
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type