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Randomized Phase II Study of Salvage XRT + ADT +/- Abiraterone Acetate and Apalutamide (ARN-509) for Rising PSA after Radical Prostatectomy with Adverse Features. Facilitating Optimal Radiation Management Using Leuprolide, Abiraterone Acetate, and Apalutamide (FORMULA-509 Trial)

Not Enrolling

Trial ID:NCT03141671

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Protocol #:16-623

877-DF-TRIAL (877-338-7425)

Condition(s):Prostate Cancer


Principal Investigator:Nguyen, Paul, L

Site Investigator(s):Bubley, Glenn,
Nguyen, Paul, L.
Orio, Peter,
Orio, Peter,

Site Research Nurse(s):Creaton, Eileen,
Kemp, Joanna, H.
Mann, Eileen, Marie
Marujo, Rose,
Morrissey, Mary Ellen,
Pasquale, Kathryn, Mary

Trial Description:
This research study is comparing two different combinations of androgen deprivation therapy (ADT) used together with radiation as a treatment for rising PSA after radical prostatectomy (prostate cancer).

Eligibility Requirements:
- Histologically confirmed prostate cancer
- PSA ≥ 0.1 after radical prostatectomy (value w/in 3 months of registration) AND at least 1 unfavorable risk factor listed below.
- Gleason 8-10
- PSA > 0.5
- Pathologically positive lymph nodes
- pT3 or pT4
- PSA doubling time (DT) < 10 months
- Negative margins
- Persistent PSA after RP (PSA never dropped below 0.1 after RP)
- Local/regional recurrence on imaging
- Decipher "High risk" (a Medicare-reimbursed test for risk of metastases after prostatectomy)
- Candidate for salvage radiation and ADT treatment
- Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. Subject must have the ability to understand and willingness to sign the written informed consent document.
- 18 ≤ Age ≤ 95 at the time of consent
- ECOG Performance Status ≤ 2 (Appendix A)
- Demonstrate adequate organ function as defined in the table below. All screening labs to be obtained within 3 months of registration.
- System Laboratory Value
- Hematological:
- Platelet count (plt) ≥ 100,000/ µL
- Hemoglobin (Hgb) ≥ 9 g/dL
- Absolute neutrophil count (ANC) ≥ 1000 cells/µL
- Renal:
--GFR1 ≥ 45 mL/min
- Hepatic and Other:
- Bilirubin2 ≤ 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN
- Serum Albumin > 3.0 g/dL
- Serum potassium ≥ 3.5 mmol/L
- Coagulation:
- International Normalized Ratio (INR)
- or Prothrombin Time (PT)
- Activated Partial Thromboplastin Time
- (aPTT) ≤ 1.5 × ULN (unless on prophylactic or therapeutic dosing with low molecular weight heparin)
- Cockcroft-Gault formula will be used to calculate creatinine clearance (see study procedure manual SPM)
- In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin; if direct bilirubin is ≤1.5 × ULN, subject may be eligible
- Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential OR agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug.
- Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
- Ability to understand and comply with study procedures for the entire length of the study as determined by the site investigator or protocol designee
- Medications known to lower the seizure threshold (see list under prohibited meds) must be discontinued or substituted at least 4 weeks prior to study entry (Section 5.5)
- Use of CYP3A4 inhibitors or inducers and CYP2D6 substrates must be discontinued prior to study entry
- Able to swallow pills
Exclusion Criteria:
- Use of post-prostatectomy ADT for > 30 continuous days prior to registration (ADT defined as use of GnRH agonist, with or without an anti-androgen). However, patients with testosterone recovery after post-prostatectomy ADT are eligible (testosterone recovery defined as total testosterone > 190 ng/dL) regardless of how long they have been on ADT.
- Prior pelvic radiation unless additional radiation can be safely delivered according to the treating physician
- PSA > 15 ng/mL in screening
- History of any of the following:
- Seizure or known condition that may predispose to seizure (e.g., prior stroke within 1 year of randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
- Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
- Current evidence of any of the following:
- Uncontrolled hypertension
- Gastrointestinal disorder affecting absorption
- Active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)
- Any chronic medical condition requiring a dose of corticosteroid higher than 10 mg prednisone/prednisolone once daily
- Any condition that, in the opinion of the site investigator, would preclude participation in this study
- Moderate or severe hepatic impairment (Child Pugh Class B or C)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, psychiatric illness or social situations that would limit compliance with study requirements
- Individuals with a history of another malignancy are not eligible if:
- the cancer is under active treatment or
- the cancer can be seen on radiology scans or
- if they are off cancer treatment but in the opinion of their oncologist have a high risk of relapse within 5 years
- Confirmed bone metastases on imaging

Protocol #: 16-623

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