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Brachytherapy

High-Dose Brachytherapy for Prostate Cancer

N/A

Waitlist Available

Led By Mark Buyyounouski

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Gleason score 6-10

No evidence of bone metastases (M0) on bone scan for PSA >20 ng/mL or Gleason ≥8 (NaF PET/CT is an acceptable substitute)

Must not have

History of rectal fistula

History of rectal surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and effectiveness of high-dose brachytherapy in treating prostate cancer that has not spread.

Who is the study for?

Men with prostate cancer that hasn't spread, having a PSA level below 150 ng/mL and no bone metastases. They should have an AUA Symptom Index score of 20 or less, Gleason score between 6-10, and clinically negative lymph nodes. Men who've had rectal surgery/fistula, T4 disease, high PSA levels (>=150 ng/mL), prior radical treatments for prostate cancer within three years or severe health issues like recent heart problems are excluded.

What is being tested?

The trial is testing high-dose brachytherapy—a type of radiation where radioactive material is placed near the tumor—to see how well it works and what side effects it has in treating localized prostate cancer compared to other treatments.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, urinary issues such as frequency or urgency, bowel changes like diarrhea or bleeding, sexual dysfunction due to nerve damage around the prostate area from radiation exposure.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer has a Gleason score between 6 and 10.

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My cancer has not spread to my bones, confirmed by a scan.

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My cancer is in an early to moderately advanced stage.

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My prostate cancer has been confirmed through a biopsy.

Exclusion Criteria

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

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I have had a rectal fistula.

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I have had surgery on my rectum.

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I haven't had heart issues like unstable angina or heart attacks in the last 6 months.

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My cancer is large or has spread to nearby areas.

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I have had surgery or radiation therapy for prostate cancer.

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I haven't had chemotherapy for any cancer in the last 3 years.

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I have a history of inflammatory bowel disease.

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

Acute Coryza

Secondary study objectives

Acute GI toxicity scored according to CTCAE v3.0 and CTCAE v4.0

Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores

Dosimetric predictors of toxicity (Doses to pelvic structures will be calculated and reviewed to determine possible correlations with toxicity outcomes)

+6 more

Side effects data

From 2016 Phase 2 trial • 60 Patients • NCT00369122

69%

White blood cell decreased

58%

Fatigue

54%

Anemia

54%

Nausea

51%

Diarrhea

44%

Platelet count decreased

42%

Vaginal hemorrhage

39%

Hypomagnesemia

29%

Hyperglycemia

29%

Lymphocyte count decreased

29%

Neutrophil count decreased

29%

Constipation

29%

Hypokalemia

27%

Hyponatremia

25%

Vomiting

24%

Hot flashes

22%

Hypoalbuminemia

20%

Headache

19%

Pelvic pain

19%

Anorexia

19%

Vaginal discharge

19%

Hypocalcemia

19%

Abdominal pain

14%

Urinary frequency

14%

Insomnia

14%

Anxiety

14%

Depression

14%

Alanine aminotransferase increased

14%

Weight loss

12%

Hypercalcemia

10%

Vaginal obstruction

10%

Dermatitis radiation

10%

Hypertension

10%

Back pain

Dysgeusia

Cystitis noninfective

Dyspnea

Creatinine increased

Rectal pain

Alkaline phosphatase increased

Dizziness

Voice alteration

Vaginal inflammation

Arthralgia

Rash maculo-papular

Aspartate aminotransferase increased

Hypotension

Peripheral sensory neuropathy

Rectal hemorrhage

Infections and infestations - Other

Vaginal pain

Urinary tract pain

Dyspepsia

Fever

Chills

Irregular menstruation

Tinnitus

Pain

Edema limbs

Proctitis

Investigations - Other

Weight gain

Urinary incontinence

Cough

Renal and urinary disorders - Other

Urinary tract infection

Vaginal infection

Nervous system disorders - Other

Epistaxis

Perineal pain

Dehydration

Hemorrhoids

Hypophosphatemia

Skin and subcutaneous tissue disorders - Other

Hyperhidrosis

Hyperkalemia

Skin induration

Myalgia

Activated partial thromboplastin time prolonged

Dry skin

Pruritus

Vascular disorders - Other

Hypoglycemia

Alopecia

Acidosis

Hyperuricemia

Uterine pain

Telangiectasia

Hemoglobinuria

Dysphagia

Gastrointestinal disorders - Other

Mucositis oral

Anal fistula

Facial nerve disorder

Blurred vision

Bladder infection

Agitation

Peripheral motor neuropathy

Lactation disorder

Non-cardiac chest pain

Lung infection

Urinary retention

Urinary tract obstruction

Extraocular muscle paresis

Allergic reaction

Pain in extremity

Vaginal fistula

Uterine hemorrhage

Blood bilirubin increased

Catheter related infection

Anal pain

Uterine obstruction

Vaginal dryness

Proteinuria

Cholesterol high

Soft tissue infection

Sinusitis

Thromboembolic event

Neck pain

Syncope

Flashing lights

Colitis

Rash acneiform

Bronchopulmonary hemorrhage

Dry mouth

General disorders and administration site conditions - Other

Ureteric anastomotic leak

Abdominal distension

Hypernatremia

Skin hypopigmentation

Skin ulceration

Reproductive system and breast disorders - Other

Vascular access complication

Musculoskeletal and connective tissue disorder - Other

GGT increased

Hearing impaired

Bone pain

Joint range of motion decreased

Flushing

Febrile neutropenia

Bladder spasm

Esophagitis

Gastritis

Chronic kidney disease

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Radiation Therapy, Bevacizumab, Cisplatin)

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 (HDR brachytherapy, ADT and LHRH agonist therapy)Experimental Treatment8 Interventions

Patients undergo high-dose-rate brachytherapy over 2 fractions. Patients also receive ADT comprising bicalutamide PO QD. Patients may also receive LHRH agonist therapy comprising leuprolide acetate IM or SC, goserelin acetate SC, triptorelin pamoate IM, or degarelix SC for 4-6 months (intermediate-risk patients receiving ADT) or 6-36 months (high-risk patients) at the discretion of the treating physician.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Internal Radiation Therapy

2006

Completed Phase 3

~290

Bicalutamide

2003

Completed Phase 3

~6210