Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer (NCT03902951) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer
United States28 participantsStarted 2021-03-17
Plain-language summary
This phase II trial studies how well antiandrogen therapy (leuprolide, apalutamide, and abiraterone acetate) and stereotactic body radiation therapy (SBRT) works in treating patients with prostate cancer that has come back and has spread to other parts of the body. Drugs used in chemotherapy, such as leuprolide, apalutamide, and abiraterone acetate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. SBRT 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. Giving antiandrogen therapy and SBRT may work better in treating patients with prostate cancer.
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:
* Confirmed diagnosis of prostate adenocarcinoma after radical prostatectomy (primary small cell carcinoma of the prostate is not allowed, however adenocarcinoma with neuroendocrine differentiation is allowed)
* Presence of 1-5 visible metastases (by PSMA PET-CT)
* At least one metastasis must be M1a-b
* Visceral metastases are not allowed
* Patients may have any number of pelvic nodal metastases (but largest must be \< 2 cm)
* Metastases must be amenable to treatment with SBRT
* Biopsy of one metastasis must be attempted, unless unsafe to perform
* Patient must be fit to undergo SBRT to all visible sites of metastases, ADT
* Total testosterone \> 150 ng/dL prior to ADT (optimal time to measure total testosterone is between 8 and 9 am)
* Adequate performance status (Eastern Cooperative Oncology Group \[ECOG\] 0-1)
* Hemoglobin \>= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
* Platelet count \>= 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
* Serum albumin \>= 3.0 g/dL
* Glomerular filtration rate (GFR) \>= 45 mL/min
* Serum potassium \>= 3.5 mmol/L
* Serum total bilirubin =\< 1.5 x upper limits of normal (ULN)
* Note: In subjects with Gilbert?s syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject may be eligible
* Aspartate aminotransferase (AST) or…
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
1
Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL