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 range18 Years
SexMALE
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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…
What they're measuring
1
Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL