Your session is about to expire
← Back to Search
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My prostate cancer has a Gleason score between 6 and 10.
Select...
My cancer has not spread to my bones, confirmed by a scan.
Select...
My cancer is in an early to moderately advanced stage.
Select...
My prostate cancer has been confirmed through a biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Coryza
Secondary outcome measures
Acute GI toxicity scored according to CTCAE v3.0 and CTCAE v4.0
Change in quality of life as measured by EPIC scores
Cost-effectiveness of HDR BT as monotherapy for prostate cancer using as measured by EQ-5D scores
+7 moreSide effects data
From 2016 Phase 2 trial • 60 Patients • NCT0036912269%
White blood cell decreased
58%
Fatigue
54%
Anemia
54%
Nausea
51%
Diarrhea
44%
Platelet count decreased
42%
Vaginal hemorrhage
39%
Hypomagnesemia
29%
Lymphocyte count decreased
29%
Constipation
29%
Neutrophil count decreased
29%
Hyperglycemia
29%
Hypokalemia
27%
Hyponatremia
25%
Vomiting
24%
Hot flashes
22%
Hypoalbuminemia
20%
Headache
19%
Anorexia
19%
Pelvic pain
19%
Hypocalcemia
19%
Vaginal discharge
19%
Abdominal pain
14%
Anxiety
14%
Urinary frequency
14%
Insomnia
14%
Alanine aminotransferase increased
14%
Weight loss
14%
Depression
12%
Hypercalcemia
10%
Dermatitis radiation
10%
Hypertension
10%
Vaginal obstruction
10%
Back pain
8%
Voice alteration
8%
Dyspnea
8%
Vaginal inflammation
8%
Dizziness
8%
Rash maculo-papular
8%
Dysgeusia
8%
Alkaline phosphatase increased
8%
Rectal pain
8%
Creatinine increased
8%
Cystitis noninfective
8%
Aspartate aminotransferase increased
8%
Peripheral sensory neuropathy
8%
Arthralgia
8%
Hypotension
8%
Rectal hemorrhage
7%
Fever
7%
Tinnitus
7%
Urinary tract pain
7%
Dyspepsia
7%
Chills
7%
Infections and infestations - Other
7%
Irregular menstruation
7%
Edema limbs
7%
Pain
7%
Vaginal pain
7%
Proctitis
5%
Nervous system disorders - Other
5%
Cough
5%
Epistaxis
5%
Urinary tract infection
5%
Urinary incontinence
5%
Dehydration
5%
Weight gain
5%
Renal and urinary disorders - Other
5%
Investigations - Other
5%
Vaginal infection
5%
Perineal pain
5%
Hemorrhoids
3%
Skin and subcutaneous tissue disorders - Other
3%
Hyperhidrosis
3%
Myalgia
3%
Telangiectasia
3%
Alopecia
3%
Skin induration
3%
Acidosis
3%
Hyperkalemia
3%
Uterine pain
3%
Vascular disorders - Other
3%
Activated partial thromboplastin time prolonged
3%
Hypophosphatemia
3%
Pruritus
3%
Hypoglycemia
3%
Hyperuricemia
3%
Dry skin
3%
Hemoglobinuria
3%
Dysphagia
3%
Gastrointestinal disorders - Other
3%
Mucositis oral
2%
Bronchopulmonary hemorrhage
2%
Blurred vision
2%
Cholesterol high
2%
Urinary tract obstruction
2%
Uterine obstruction
2%
Facial nerve disorder
2%
Flashing lights
2%
Uterine hemorrhage
2%
Bladder infection
2%
Bone pain
2%
Vaginal dryness
2%
Agitation
2%
Rash acneiform
2%
General disorders and administration site conditions - Other
2%
Peripheral motor neuropathy
2%
Proteinuria
2%
Reproductive system and breast disorders - Other
2%
Neck pain
2%
Syncope
2%
Abdominal distension
2%
Soft tissue infection
2%
Allergic reaction
2%
Anal fistula
2%
Anal pain
2%
Catheter related infection
2%
Non-cardiac chest pain
2%
Lung infection
2%
Skin ulceration
2%
Vascular access complication
2%
Extraocular muscle paresis
2%
Blood bilirubin increased
2%
GGT increased
2%
Dry mouth
2%
Hearing impaired
2%
Joint range of motion decreased
2%
Ureteric anastomotic leak
2%
Thromboembolic event
2%
Vaginal fistula
2%
Colitis
2%
Sinusitis
2%
Hypernatremia
2%
Skin hypopigmentation
2%
Musculoskeletal and connective tissue disorder - Other
2%
Pain in extremity
2%
Lactation disorder
2%
Urinary retention
2%
Flushing
2%
Febrile neutropenia
2%
Bladder spasm
2%
Esophagitis
2%
Gastritis
2%
Chronic kidney disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Radiation Therapy, Bevacizumab, Cisplatin)
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
~5330
Leuprolide Acetate
2002
Completed Phase 3
~1890
Goserelin Acetate
2007
Completed Phase 3
~1040
Triptorelin Pamoate
2003
Completed Phase 3
~100
Degarelix
2002
Completed Phase 3
~3600
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,387 Previous Clinical Trials
17,333,887 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,504 Total Patients Enrolled
Mark BuyyounouskiPrincipal InvestigatorStanford University Hospitals and Clinics
1 Previous Clinical Trials
296 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My prostate cancer has a Gleason score between 6 and 10.My cancer has not spread to my bones, confirmed by a scan.I have had a rectal fistula.My cancer is in an early to moderately advanced stage.I have had surgery on my rectum.I haven't had heart issues like unstable angina or heart attacks in the last 6 months.My prostate cancer has been confirmed through a biopsy.My lymph nodes are cancer-free as confirmed by tests or they are small if uncertain.My cancer is large or has spread to nearby areas.I have had surgery or radiation therapy for prostate cancer.I haven't had chemotherapy for any cancer in the last 3 years.I have a history of inflammatory bowel disease.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (HDR brachytherapy, ADT and LHRH agonist therapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research break new ground in its field?
"Currently, Internal Radiation Therapy is being evaluated in 141 different active trials that span 56 countries and 1458 cities. This clinical research was first undertaken by AstraZeneca back in 2000 with 600 test subjects throughout its Phase 3 approval process; since then an additional 997 studies have been conducted."
Answered by AI
How many individuals are enrolled in this clinical investigation?
"This trial is not presently accepting new participants. It was initially advertised on January 13th, 2015 and last edited on September 7th, 2022. For those seeking alternatives, there are 1275 studies actively recruiting patients with stage iia prostate cancer while 141 trials for Internal Radiation Therapy search out enrollees."
Answered by AI
Are any spots available for this clinical experiment?
"It appears that, as of this moment in time, there are no new candidates being sought for the clinical trial described on clinicaltrials.gov which was first published on January 13 2015 and last updated September 7 2022. Despite this fact, a substantial number of other medical trials--1416 to be exact--are actively recruiting patients right now."
Answered by AI
To what medical conditions does Internal Radiation Therapy typically provide a remedy?
"Breast cancer is often treated with Internal Radiation Therapy, which can also be deployed to manage radiation therapy, reduce endometrial thickness, and provide therapeutic relief."
Answered by AI
Has Internal Radiation Therapy been employed in any other prior clinical experiments?
"Currently, 141 studies are being conducted on Internal Radiation Therapy with 47 of them in the third phase. While Duarte, California has several trials for this therapy, there are 9544 other sites running clinical research dedicated to it."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger