CompletedNot Applicable

Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery

United States11 participantsStarted 2016-06-15

Plain-language summary

This phase I trial studies stereotactic body radiation therapy (SBRT) in treating patients with prostate cancer that is likely to come back or spread (high-risk) undergoing surgery. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Delivering radiotherapy before prostatectomy by SBRT is more convenient, conformal, and may spare normal tissues better than delivering radiotherapy after prostatectomy.

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 primary non-metastatic adenocarcinoma of the prostate * Patient desires and is medically fit to undergo prostatectomy * Karnofsky performance status (KPS) \>= 70 * Patients on androgen deprivation therapy (ADT) are allowed * For confirmation of high risk local failure status, patients will have any one of the following: * Computed tomography (CT) or magnetic resonance imaging (MRI) demonstrating seminal vesicle invasion (SVI) or extraprostatic extension (EPE) within 1 year of enrollment into the study * Pre-biopsy prostate-specific antigen (PSA) \>= 20 * Gleason score 7-10 (Gleason 7 must be 4+3), presence of any Gleason 5 (even if a tertiary score) as determined at diagnostic biopsy * Gleason score 7 and \> 50% of biopsy cores positive for prostate cancer * Clinical stage \>= T3 (staging by imaging acceptable) * An image-guided biopsy (via Artemis Ultrasound with MRI co-registration) is encouraged but not required if not performed as standard of care biopsy Exclusion Criteria: * Distant metastases, based upon: * CT scan or MRI of the abdomen/pelvis or prostate specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) within 120 days prior to registration and * Bone scan or PSMA PET/CT within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis prior to registration * Patient is unable or unwilling to si…

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.

What they're measuring

Number of Participants Who Completed the Maximum Time Allowed on Study Without Severe Acute Surgical Complications

Timeframe: At 4 weeks post surgery

Trial details

NCT IDNCT02830165

SponsorJonsson Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-09

Results submitted2021-10-12

View on ClinicalTrials.gov More Stage I Prostate Adenocarcinoma American Joint Committee on Cancer (AJCC) v7 trials