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New treatment option for Prostate Cancer
Official title A Pilot Presurgical Trial of REGN5678 (Anti-PSMA x CD28) in Patients With High-risk, Localized Prostate Cancer Followed by Radical Prostatectomy
ClinicalTrials.gov ID: NCT06085664
What this study is testing
What is REGN5678?
REGN5678 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for prostate cancer.
Also referred to as PYLARIFY.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To learn about the safety and effects of a drug called REGN5678 when it is given to patients with high-risk prostate cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Men ≥ 18 years of age
- Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1
- No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging...
- Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus...
You likely can't join if
- Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or...
- Currently enrolled in another treatment study
- Concurrent treatment with systemic corticosteroids (prednisone dose \> 10 mg per day or equivalent) or other immunosuppressive drugs \< 14 days prior...
- History of or known or suspected autoimmune disease (exception(s): people with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or...
- Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection...
- History of clinically significant cardiovascular disease including, but not limited to:
See the full eligibility criteria
Who can join
- Men ≥ 18 years of age
- Histologically documented Gleason 8 or greater prostatic adenocarcinoma in at least 3 biopsy cores and at least 8 mm of disease on a single core of Gleason 8 or greater. Prostate biopsy within 3 months of screening is...
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of 0 or 1
- No evidence of metastatic disease as documented by technetium-99m (99mTc) bone scan and by computed tomography (CT) or magnetic resonance imaging (MRI) scans. Imaging may be obtained up to 60 days prior to enrollment
- Localized or locally advanced disease deemed by the surgeon to be resectable. Patients must be appropriate candidates for radical prostatectomy plus pelvic lymph node dissection
- No prior treatment for prostate cancer including prior surgery (excluding transurethral resection of the prostate [TURP]), cryoablation, pelvic lymph node dissection, radiation therapy, hormonal therapy or chemotherapy
- Hemoglobin ≥ 11 g/dL
- Absolute neutrophil count ≥ 1.5 x 10\^9/L
- Platelet count ≥ 100 x 10\^9/L
- Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated glomerular filtration rate \> 50 mL/min/1.73 m\^2. A 24-hour urine creatinine collection may substitute for the calculated creatinine clearance to meet...
- Total bilirubin ≤ 1.5 x ULN
- NOTES: Patients with Gilbert's syndrome do not need to meet total bilirubin requirements provided their total bilirubin is not greater than their historical level. Gilbert's syndrome must be documented appropriately as...
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Alkaline phosphatase (ALP) ≤ 2.5 x ULN
- Consent to MD Anderson laboratory protocol PA13-0291
- Willing and able to comply with clinic visits and study-related procedures
- Provide informed consent signed by study patient
- To avoid risk of drug exposure through the ejaculate (even men with vasectomies), people must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. If the...
What rules you out
- Prior hormone therapy for prostate cancer including orchiectomy, antiandrogens, ketoconazole, or estrogens (5-alpha reductase inhibitors allowed), or luteinizing hormone-releasing hormone (LHRH) agonists/antagonists
- Currently enrolled in another treatment study
- Concurrent treatment with systemic corticosteroids (prednisone dose \> 10 mg per day or equivalent) or other immunosuppressive drugs \< 14 days prior to treatment initiation. Steroids that are topical, inhaled, nasal...
- History of or known or suspected autoimmune disease (exception(s): people with vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed)
- Known evidence of an active infection requiring systemic therapy such as human immunodeficiency virus (HIV), active hepatitis, or fungal infection. Patients with known HIV infection which is well-controlled...
- History of clinically significant cardiovascular disease including, but not limited to:
- Myocardial infarction or unstable angina ≤ 6 months prior to treatment initiation
- Clinically significant cardiac arrhythmia
- Deep vein thrombosis, pulmonary embolism, stroke ≤ 6 months prior to treatment initiation
- Congestive heart failure (New York Heart Association class III-IV)
- Pericarditis/clinically significant pericardial effusion
- Myocarditis
- Endocarditis
- History of major implant(s) or device(s), including but not limited to:
- Prosthetic heart valve(s)
- Artificial joints and prosthetics placed ≤ 12 months prior to treatment initiation
- Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed
- Other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) ≤ 2 years prior to enrollment
- Has received major surgery within 14 days of first administration of study drug
- Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living [ADLs]) or uncontrolled seizures in the year prior to first dose of study...
- Known history of, or any evidence of interstitial lung disease, or active, non-infectious pneumonitis (past 5 years)
- Receipt of a live vaccine within 4 weeks of planned start of study medication
- Prior allogeneic stem cell transplantation or recipients of organ transplants at any time, or autologous stem cell transplantation within 12 weeks of the start of study treatment
- Any medical, psychological or social condition that in the opinion of the investigator, would preclude participation in this study
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.