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Radiation Therapy

SBRT for Localized Prostate Cancer Post-Surgery

Phase 2

Waitlist Available

Led By Amar Kishan, MD

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

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

Karnofsky performance score (KPS) >= 70

Must not have

Patients with neuroendocrine or small cell carcinoma of the prostate

Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well SBRT works in treating patients with prostate cancer that has not spread & have undergone surgery.

Who is the study for?

Men with localized prostate cancer treated by surgery can join this trial. They must have a history of adenocarcinoma, no distant metastases, and not received prior pelvic radiotherapy or certain other prostate treatments. A Karnofsky score of 70+ (able to care for themselves) and rising PSA levels post-surgery are required.

What is being tested?

The trial is testing stereotactic body radiation therapy (SBRT), which targets the tumor with high-precision x-rays over several days, potentially sparing healthy tissue. It's for patients whose cancer hasn't spread and includes antiandrogen therapy and quality-of-life assessments.

What are the potential side effects?

Potential side effects include skin irritation at the treatment site, fatigue, urinary issues like increased frequency or discomfort, bowel changes such as diarrhea or rectal bleeding, erectile dysfunction, and less commonly inflammation of surrounding organs.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer surgery showed high-risk features or my PSA levels are rising.

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

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I had surgery to remove prostate cancer.

Exclusion Criteria

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

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My prostate cancer is of the neuroendocrine or small cell type.

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

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I have had radiation therapy to my pelvic area before.

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My prostate cancer has spread to nearby lymph nodes.

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I have a history of Crohn's disease, ulcerative colitis, or ataxia telangiectasia.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 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 recurrence-free survival (BCRFS)

Patient-reported toxicity outcomes EPIC-26

Patient-reported toxicity outcomes IPSS

+1 more

Secondary study objectives

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

Other study objectives

Patient-reported toxicity outcomes; patients treated utilizing a linear accelerator

Patient-reported toxicity profiles patients treated utilizing the magnetic resonance imaging (MRI)-guided device

Physician-scored Toxicity profiles patients treated utilizing a linear accelerator

+1 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446

87%

Fatigue

53%

Nausea

33%

Cough

27%

Anemia

27%

Fall

27%

Dyspnea

27%

Pain

27%

Depression

27%

Lymphocyte count decreased

27%

Platelet count decreased

20%

Chills

20%

Dizziness

20%

Chest pain

20%

Neutropenia

20%

Diarrhea

20%

Edema limbs

13%

Skin infection

13%

Dysesthesia

13%

Edema

13%

Insomnia

13%

Constipation

13%

Delirium

13%

Dysgeusia

13%

Vomiting

13%

Tinnitus

13%

Rash

13%

Myalgia

13%

Back pain

13%

Weakness (limb)

13%

Weight loss

Proteinuria

Bruising

Oral lesions

Hearing loss

Anxiety

Headaches

Weakness (facial)

Acute kidney injury

Hypokalemia

Lymphocytopenia

Seizures

Hearing impaired

Hypernatremia

Hypertension

Neutrophil count decreased

Headache

Creatinine increased

Fever

Pleural effusion

Death NOS

Gait disturbance

Nasal congestion

Tremor

Urinary urgency

Amnesia

Photophobia

Urinary frequency

Dysphagia

Low white blood count

Sneezing

Cognitive disturbance

Erythema multitforme

Lung infection

Allergy (seasonal)

Muscle weakness

Hypomagnesemia

Parathesia (tingling)

Febrile Neutropenia

Anorexia

Hypoxic respiratory failure

Sleep apnea

Encephalopathy

Hypoxia

Shingles

100%

80%

60%

40%

20%

Study treatment Arm

Maintenance Chemotherapy

Stereotactic Body Radiation Therapy

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, ADT)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Antiandrogen Therapy

2015

Completed Phase 1

~10

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~790