A Multicenter, Randomized, Controlled Phase 2 Study: Efficacy and Safety of I-131-1095 Radiotherapy in Combination With Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Who Are 18F-DCFPyL Prostate-specific Membrane Antigen (PSMA)-Avid, Chemotherapy-naive, and Progressed on Abiraterone
Condition: Metastatic Prostate Cancer, Castration-resistant Prostate Cancer, Prostatic Neoplasm, Cancer of the Prostate, Progressive mCRPC
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT03939689
Sponsor: Progenics Pharmaceuticals, Inc.
Phase: Phase 2
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: Male
Inclusion Criteria:
- Male ≥ 18 years of age
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features at initial diagnosis
- Castration-resistant prostate cancer, with serum testosterone ≤ 50 ng/dL at Screening
- Radiographic evidence of metastatic disease prior to Randomization or up to 21 days prior to Screening
- Disease progression on prior abiraterone therapy as defined by meeting at least one of the following criteria per the investigator:
- PSA progression as defined by a minimum of two rising PSA levels at least 1 week apart
- Soft tissue disease progression defined by RECIST 1.1
- Bone disease progression defined by two or more new lesions on bone scan
- Planned to receive treatment with enzalutamide
- Subjects who are ineligible or choose not to receive taxane-based chemotherapy based on personal preference or physician opinion. Examples of conditions that could make a patient ineligible or refuse to receive taxane-based chemotherapy, but would allow them to still be eligible to receive I-131-1095 include the following:
- Poor performance status
- Prior intolerance to cytotoxic agents
- History of another malignancy suspected for recurrence or metastases
- Other serious medical conditions such as symptomatic peripheral neuropathy CTCAE Grade 2 or higher; or clinically significant cardiovascular disease per the Investigator or treating physician
- Subjects receiving bisphosphonate therapy must have been on stable doses for at least 4 weeks prior to Randomization
- ECOG performance status 0-2
- If sexually active, agree to use a medically acceptable method of birth control or sexual abstinence from the time of dosing through 28 days after the last dose of I-131-10
- Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.
- Estimated life expectancy of at least 6 months as determined by the Investigator.
- Able and willing to provide signed informed consent and comply with protocol requirements
Exclusion Criteria:
- Received any anti-tumor therapy within 4 weeks of Randomization, with the exception of abiraterone, GnRH therapy and non-radioactive bone-targeted agents
- Received prior chemotherapy for castration-resistant prostate cancer
- Superscan as evidenced on baseline bone scan
- Treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 within 6 months prior to Randomization
- Prior hemi-body irradiation
- Prior PSMA-targeted radioligand therapy
- Major surgery within 4 weeks of Randomization
- Impaired organ function as evidenced by the following laboratory values at Screening:
- Absolute neutrophil count < 1500 μL
- Platelet count < 100,000/μL
- Hemoglobin < 9.5 g/dL
- Albumin < 3.0 g/dL (30 g/L)
- Total bilirubin > 2 x ULN unless in instances of known or suspected Gilbert's disease
- AST or ALT > 2.5 x ULN
- Calculated creatinine clearance (CrCL) < 30 mL/min (Cockroft-Gault equation), or currently on renal dialysis.
- QT interval corrected for heart rate (QTc) > 470 msec
- Previous use of enzalutamide for more than 7 days prior to consent
- Planned initiation of alternative therapy for prostate cancer, investigational therapy, or participation in clinical trials during the study
- History or risk of seizure (i.e., clinically significant neurological disorder) or any other condition that contraindicates treatment with enzalutamide
- Gastrointestinal disorder affecting absorption of oral medications
- Known or suspected brain metastasis or active leptomeningeal disease
- Active malignancy other than prostate cancer, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or non-muscle invasive bladder/urothelial cancer
- Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completing the study.
View trial on ClinicalTrials.gov