A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) … (NCT05169970) | Clinical Trial Compass
RecruitingPhase 2
A Study of Stereotactic Body Radiation Therapy (SBRT) Without Androgen Deprivation Therapy (ADT) in People With Unfavorable Intermediate-Risk Prostate Cancer
United States215 participantsStarted 2021-12-09
Plain-language summary
The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation treatments
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:
* Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment
* Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features:
* Gleason Score 4+3
* ≥ 50% biopsy cores positive
* Two or more of the following risk factors:
* Grade Group 2 or 3
* cT2b-T2c
* PSA 10 - 20 ng/mL
* Able to undergo MRI for initial staging and MR based radiation planning
* Sufficient biopsy tissue available for Decipher genomic testing
* Prostate volume \< 90cc
* IPSS ≤ 20
* Age ≥ 18
* KPS ≥ or ECOG 0-2
* Estimated life expectancy \>5 years
* Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
Exclusion Criteria:
* Radiographic T3-T4 detected on staging mpMRI
°Must be "consistent with" (\>90% probability) or suspicious for/probable/probably (75%-90% probability) ofT3-T4 disease determined by the reading radiologist.
* Evidence of distant metastases as determined by MRI, PET, or CT imaging
* Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging
* Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
* Prior pelvic radiation
* Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resect…
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.