Prostate Cancer Clinical Trial
Official title:
A Phase 2 Study of Nivolumab in Patients With High-Risk Biochemically Recurrent Prostate Cancer
Verified date | January 2024 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This research study is studying an immune-based cancer drug as a possible treatment for prostate cancer. The drug involved in this study is: -Nivolumab
Status | Active, not recruiting |
Enrollment | 31 |
Est. completion date | March 31, 2025 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients must have signed an informed-consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study. - Patients must have a history of prostate adenocarcinoma (adenocarcinoma must be the primary histology; secondary components of variant histologies are acceptable) confirmed on biopsy and treated with primary radical prostatectomy (RP) or definitive radiation (RT). Prior salvage RT is acceptable. - Patients must have experienced biochemical recurrence (BCR) plus have minimum PSA values noted below: - Following primary RP: Any detectable rising PSA after RP (or after salvage RT if performed), minimum PSA 1.0 at time of screening - Following primary RT: PSA rise to =2 ng/mL above the nadir - No evidence of metastases on conventional imaging (CT or MRI plus bone scan) - PSA doubling time (PSADT) <10 months --PSADT: calculated as per Prostate Cancer Working Group 3 (PCWG3) and the Memorial Sloan Kettering Cancer Center calculator: (https://www.mskcc.org/nomograms/prostate/psa_doubling_time) With linear regression model of normal logarithm of PSA and time, based on: - At least 3 consecutive PSA values with each value =0.2 ng/mL - Interval between first and last PSA values is =8 weeks but =12 months. -Archival tissue is mandatory, either prostatectomy specimen or (in patients who received primary RT) diagnostic core biopsies. Patients must consent to next-generation sequencing performed on this tissue. - If diagnostic core biopsies are only available tissue, at least 3 cores must be involved by tumor - Easteron Cooperative Oncology Group (ECOG) performance status 0-1 - Age =18 years - Adequate organ and marrow function: - System Laboratory Value - Hematological - White blood cell (WBC) = 2000/µL - Absolute Neutrophil Count (ANC) = 1500/µL - Platelets (Plt) = 100 x103/µL - Hemoglobin (Hgb) > 9.0 g/dL (with or without transfusion) -Renal - Serum Creatinine = 2 x ULN - Hepatic - Bilirubin1 = 1.5× upper limit of normal (ULN) - Aspartate aminotransferase (AST) = 3 × ULN - Alanine aminotransferase (ALT) = 3 × ULN - Except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL - Baseline testosterone =100 ng/dL - Recovery from acute toxicity related to prior therapy, including surgery and radiation, or no treatment-related toxicity = grade 2. - History of prior malignancy or concurrent separate malignancy is not an exclusion criterion so long as the non-prostate malignancy is stable and does not require any treatment. - Able to understand and sign informed consent and adhere to study procedures. - Male patients whose female partners are of reproductive potential must agree to use a contraception during the trial period Exclusion Criteria: - Current use of ADT or plan to initiate ADT during trial period - Major surgery or radiation therapy within 14 days of starting study treatment - Subjects with active autoimmune disease. Patients with a history of autoimmune disease that has not required systemic immunosuppressive therapy or does not threaten vital organ function including central nervous system, heart, lungs, kidneys, skin, and gastrointestinal tract will be allowed. - Known history of immune deficiencies or chronic viral infections including HIV, hepatitis B (HBV), and hepatitis C (HCV) (patients with prior therapy for HBV or HCV is permitted if viral clearance was documented). - Concurrent medical condition requiring use of systemic corticosteroids with prednisone >10 mg per day or equivalent. Use of inhaled, nasal, and topical steroids (applied to small body areas) is allowed. - Current use (within past 4 weeks) of other prohibited medications including anti-cancer therapies, hormonal therapies, 5-alpha reductase inhibitors, and alternative medications known to alter PSA (e.g. phytoestrogens and saw palmetto). - Prior treatment with immune checkpoint inhibitors. (Prior cancer vaccines are allowed.) - Serious intercurrent medical or psychiatric illness that, in the judgment of the investigator, would interfere with patient's ability to carry out the treatment program |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | St. Elizabeth's Medical Center | Boston | Massachusetts |
United States | DFCI Londonderry | Londonderry | New Hampshire |
United States | DFCI South Shore | South Weymouth | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Bristol-Myers Squibb, Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease Control | Proportion of patients with high-risk biochemically-recurrent (BCR) prostate cancer (PCa) that experiences decline or stabilization in PSA (without symptomatic/radiographic progression) after 12 weeks of nivolumab treatment | 12 weeks | |
Secondary | Maximal change in prostate specific antigen (PSA) during nivolumab treatment | 2 years | ||
Secondary | Best PSA response during nivolumab treatment as an absolute change relative to baseline | 2 years | ||
Secondary | Change in PSA doubling time (PSADT) at end-of-study relative to baseline | 2 years | ||
Secondary | Time from enrollment to development of radiographic metastatic disease | 2 years | ||
Secondary | Time from enrollment to initiation of androgen deprivation therapy (ADT) | 2 years | ||
Secondary | Treatment-related adverse events as assessed by CTCAE v5.0 | 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Active, not recruiting |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |