Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy (NCT03412396) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy
United States45 participantsStarted 2018-03-22
Plain-language summary
This phase II trial studies how well apalutamide works in treating patients with prostate cancer before radical prostatectomy. Androgen can cause the growth of prostate cancer cells. Hormone therapy using apalutamide may fight prostate cancer by lowering the amount of androgen the body makes and may make it less likely for patients to receive radiation therapy after surgery.
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:
* Willing and able to provide written informed consent
* Histologically confirmed adenocarcinoma of the prostate
* A minimum of 10 core biopsies have been performed at baseline and available. A prostate biopsy within 6 months from screening is allowed for entry requirements. Biopsies performed within 6-12 months from screening are acceptable if the treating physician would allow treatment without further biopsy. Patients must meet intermediate risk criteria from Gleason score, T stage, and prostate-specific antigen (PSA) value by National Comprehensive Cancer Network (NCCN) criteria: cT2b-T2c or Gleason 7 (3+4 or 4+3) or PSA 10-20 ng/mL. In addition, the Gleason 3+4 or 4+3 must be present
* Pathology review at MD Anderson Cancer Center. The volume of disease must be high enough for the surgeon to agree to include an extended template pelvic lymph node dissection
* Serum testosterone \> 200 ng/mL
* Patient and urologist must agree that patient is suitable for prostatectomy
* No evidence of metastases on imaging. This risk group does not require metastatic studies, but if performed they must be negative (as determined by urologist or radiologist). Suspicious lymph nodes permissible if \< 10 mm
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Hemoglobin \>= 10.0 g/dL
* Platelet count \>= 100,000 x 10\^9/microliter
* Glomerular filtration rate (GFR) \>= 45 mL/min
* Serum potassium \>= 3.5 mmol/L
* Serum albumin \>= 3.0 g/dL
* Able to sw…
What they're measuring
1
Number of Adverse Surgical Pathology Features at Risk of Pelvic Radiation Therapy
Timeframe: Assessed at time of surgical specimen microscopic evalution Assessed at time of surgical specimen microscopic evaluation