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Brachytherapy

Brachy for Prostate Cancer

Phase 2
Waitlist Available
Led By Kevin A Camphausen, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This study will evaluate the use of magnetic resonance imaging (MRI) for guiding placement of hollow needles into the prostate gland for delivering internal radiation therapy to patients with prostate cancer. Prostate cancer is often treated with a combination of external beam radiation therapy and brachytherapy (internal radiation delivered close to the tumor). This study will determine whether MRI is more accurate in guiding needle placement than ultrasound, which is currently used for this purpose. Patients will have one brachytherapy treatment followed by 5 weeks of external beam treatments and a second brachytherapy. Patients 18 years of age and older with prostate cancer that has not spread to the bone may be eligible for this study. Candidates will be screened with a physical examination, blood and urine tests, and a bone scan. To plan for radiation therapy, patients will have standard computed tomography (CT) and MRI scans of the pelvis and prostate. In addition, CT and MRI scans will be done to determine if the prostate is in a good position for brachytherapy. For these scans, patients will have an enema and a tube will be placed in the rectum. They will then lie still on their side for about 45 minutes during the scan. Patients who have blood in their urine will also undergo cystoscopy. This is an examination of the bladder using a small camera that is advanced through the penis into the bladder. Patients are given an antibiotic for 2 days before the brachytherapy and on the morning of the procedure. Before the test, they have a small enema and are given medicines through the vein and into the spine for relaxation and to decrease any discomfort. (The test is done under general anesthesia for patients who require it.) The patient is moved on a stretcher into the MRI scanner and a catheter is inserted into the bladder through the penis. The bladder is filled with water and a tube is placed in the rectum. With the help of a plastic guide placed against the skin, about 14 to 18 needles are then placed in the prostate. Some stitches are sewn to hold the needles and the guide in place, and the tube in the rectum is removed. The patient is the transferred from the MR scanner into the CT scanner, where the rectal tube is reinserted and the needles are adjusted. A cystoscopy is done to make sure the needles do not enter the bladder. When the needles are adjusted, the tube is removed from the rectum and the patient is moved to the radiation oncology clinic. After a few hours, when the radiation dose has been calculated, a radioactive substance called iridium is administered. The needles placed in the prostate are connected to a radiation machine, and thin wires with radioactive material on the tips are inserted into each needle and withdrawn a little at a time. The process takes about 20 to 30 minutes. The patient is then disconnected from the machine and undergoes another MRI scan to confirm the position of the needles. The needles and catheter are then removed and the patient is monitored for a while before going home. Patients then have 5 weeks of external beam therapy, followed by a second brachytherapy treatment. Patients return to the clinic at 1, 3, 6, 12, 18, 24, 36, 48, and 60 months after treatment for blood tests, physical examination, and review of symptoms.

Eligible Conditions
  • Prostate Cancer

Timeline

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

Side effects data

From 2021 Phase 3 trial • 926 Patients • NCT01414608
79%
Fatigue
76%
Nausea
73%
Diarrhea
71%
Lymphocyte count decreased
65%
Anemia
36%
Vomiting
35%
Abdominal pain
31%
Vaginal discharge
31%
Platelet count decreased
28%
Pelvic pain
26%
Neutrophil count decreased
24%
Peripheral sensory neuropathy
22%
General disorders NOS
20%
Cystitis noninfective
17%
Alanine aminotransferase increased
16%
Pain in extremity
14%
Dermatitis radiation
12%
Creatinine increased
12%
Dehydration
11%
Vaginal pain
10%
Myalgia
10%
Hemorrhage Bladder
9%
Aspartate aminotransferase increased
9%
Hearing impaired
8%
Proctitis
8%
Vaginal dryness
8%
Alopecia
7%
Hemorrhage Rectum
7%
Vaginal stricture
6%
Mucositis oral
6%
Thrombosis/Thrombus/Embolism
6%
Urinary tract pain
4%
Allergic reaction/ hypersensitivity
4%
Rectal pain
3%
Anal pain
3%
Colitis
3%
Lymphedema
2%
Perineal pain
2%
Telangiectasia
2%
Enterocolitis
2%
Febrile neutropenia
2%
Female genital tract fistula
2%
Peripheral motor neuropathy
2%
Tumour pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Chemoradiation
Standard Chemoradiation With Adjuvant Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: BrachyExperimental Treatment1 Intervention
brachytherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brachytherapy
2007
Completed Phase 3
~2130

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,010,825 Total Patients Enrolled
568 Trials studying Prostate Cancer
529,879 Patients Enrolled for Prostate Cancer
Kevin A Camphausen, M.D.Principal InvestigatorNational Cancer Institute (NCI)
14 Previous Clinical Trials
3,251 Total Patients Enrolled
3 Trials studying Prostate Cancer
54 Patients Enrolled for Prostate Cancer
~1 spots leftby Sep 2025