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Radiation Therapy

Stereotactic Body Radiation for Prostate Cancer

N/A

Waitlist Available

Led By Amar Kishan

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Karnofsky performance status (KPS) >= 70

Histologically confirmed primary non-metastatic adenocarcinoma of the prostate

Must not have

Hormonal therapy exceeding 4 months prior to registration

Prior pelvic radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a new type of radiation therapy can better treat prostate cancer without damaging nearby tissue.

Who is the study for?

This trial is for men with high-risk prostate cancer that hasn't spread beyond the prostate or to lymph nodes. Participants must have a Karnofsky performance status of 70 or above, indicating they can care for themselves. They should not have had extensive hormone therapy, prior cryosurgery, HIFU, brachytherapy, pelvic radiotherapy, nor suffer from Crohn's disease or Ulcerative colitis.

What is being tested?

The study tests stereotactic body radiation therapy (SBRT) on patients with localized high-risk prostate cancer. SBRT delivers a concentrated dose of radiation aiming to kill more tumor cells while sparing healthy tissue. The trial also assesses how this treatment affects patients' quality of life and monitors changes through lab biomarker analysis.

What are the potential side effects?

Potential side effects include damage to surrounding tissues leading to urinary and bowel issues; fatigue; skin reactions in the treated area; and possible sexual dysfunction due to the proximity of treatment areas to reproductive organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself but may not be able to do active work.

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My prostate cancer has not spread and was confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been on hormonal therapy for more than 4 months.

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I have had radiation therapy to my pelvic area before.

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I have a history of Crohn's disease or Ulcerative colitis.

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I have had cryosurgery, HIFU, or brachytherapy for prostate cancer.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biochemical progression free survival

Side effects data

From 2016 Phase 2 trial • 59 Patients • NCT00087438

55%

Dyspnea

38%

Fatigue

33%

Cough

24%

Hemoglobin

20%

Pulmonary/upper respiratory - Other

16%

Chest wall pain

16%

Fracture NOS

16%

Forced expiratory volume

15%

Nausea

15%

Pneumonitis NOS

15%

Chest pain

11%

Blood/bone marrow - Other

11%

Dermatitis radiation NOS

11%

Blood creatinine increased

Pleural effusion

Vomiting NOS

Hyperglycemia NOS

Hypoalbuminemia

Lymphopenia

Pulmonary function test NOS decreas

Hypocalcemia

Abdominal pain NOS

Headache

Hypoxia

Edema: limb

Blood bilirubin increased

Peripheral sensory neuropathy

Rigors

Hypokalemia

Myalgia

Atrial fibrillation

Diarrhea NOS

Musculoskeletal/soft tissue - Other

Muscle weakness NOS

Hyponatremia

Pyrexia

Pain - Other

Infection with Grade 3 or 4 neutrop

Activated partial thromboplastin ti

Blood alkaline phosphatase increase

Metabolic/laboratory - Other

Weight decreased

Renal/genitourinary - Other

Atelectasis

Anorexia

Pulmonary hypertension NOS

Dysphagia

Lymphatics - Other

Cardiac general - Other

Constipation

Insomnia

100%

80%

60%

40%

20%

Study treatment Arm

Stereotactic Body Radiation Therapy (SBRT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (SBRT)Experimental Treatment4 Interventions

Patients undergo SBRT daily or every other day for a total of 5 fraction not exceeding 14 consecutive days. Patients may also receive androgen deprivation therapy for up to 9 months at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

androgen deprivation therapy

2012

Completed Phase 3

~690

stereotactic body radiation therapy

2019

Completed Phase 2

~470