Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer (NCT04399824) | Clinical Trial Compass
WithdrawnNot Applicable
Focal Radiation Therapy for the Treatment of Low or Intermediate-Risk Prostate Cancer
Stopped: Study did not open
United States0Started 2020-04-03
Plain-language summary
This phase II trial studies how well focal radiation therapy with stereotactic body radiation therapy (SBRT) or high-dose rate (HDR) brachytherapy works in treating patients with low or intermediate-risk prostate cancer. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. HDR brachytherapy uses high doses of radiation to target these tumor cells. Giving focal radiation therapy with SBRT or HDR brachytherapy may target dominant tumor cells while sparing the reminder of the prostate or surrounding normal organs and ultimately reduce side effects while maintaining disease control.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed diagnosis of prostate adenocarcinoma within 90 days prior to registration via systematic biopsy and with the following low/intermediate-risk features:
* cT1c - T2b
* PSA =\< 15
* \< 50% cores positive
* Gleason score (GS) =\< 7 (3+4 and 4+3 included)
* Multiparametric magnetic resonance imaging (MRI) (mp-MRI) confirmed lesion(s) with only one lobe involvement of the prostate
* Unilateral disease on systematic biopsy
* No distant or locally advanced disease on standard staging exams as indicated
* Bone scan and abdominopelvic computed tomography (CT)/MRI OR
* Prostate specific membrane antigen (PSMA) positron emission tomography (PET)
* Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status 0/1 within 60 days prior to enrollment
Exclusion Criteria:
* Gleason score \>= 8
* Gross extracapsular extension
* Seminal vesicle invasion
* Radiographic nodal or distant metastatic disease
* Androgen deprivation therapy within 90 days of enrollment
* Lesion(s) comprising \> 40% of total prostate volume
* Lesion \< 0.5 cm from urethra
* Prior radical prostatectomy
* Prior radiotherapy to the pelvis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.