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New treatment option for Castration-Resistant Prostate Carcinoma
Official title Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial
ClinicalTrials.gov ID: NCT06632977
What this study is testing
What is Valemetostat Tosylate?
Valemetostat Tosylate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for castration-resistant prostate carcinoma.
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
- This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
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
You may be able to join if
- PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and...
- PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
- PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable)...
- PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act...
- PRE-REGISTRATION: Age ≥ 18 years.
See the full eligibility criteria
Who can join
- PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not...
- PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
- PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have...
- PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned...
- PRE-REGISTRATION: Age ≥ 18 years.
- REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND one or more of the following criteria (choose all the apply):
- PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of...
- Radiographic progression per RECIST 1.1 criteria for soft tissue lesions
- Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
- REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For...
- REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive...
- REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline...
- Chemotherapy-induced neuropathy
- Fatigue
- Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation...
- REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including...
- REGISTRATION: No major surgery within 4 weeks of registration.
- REGISTRATION: No prior treatment with EZH inhibitors.
- REGISTRATION: Prior treatment with cabazitaxel + carboplatin.
- REGISTRATION: None of the following conditions:
- Current use of moderate or strong cytochrome P450 (CYP)3A inducers.
- Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must...
- Imminent or established spinal cord compression based on clinical and/or imaging findings.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least...
- Significant cardiovascular defined as:
- Myocardial infarction within 6 months prior to enrollment.
- Uncontrolled angina pectoris within 6 months prior to enrollment.
- New York Heart Association Class 3 or 4 congestive heart failure.
- Corrected QT interval calculated by the Fridericia\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which...
- Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg).
- Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy.
- Moderate to severe hepatic impairment (Child-Pugh Class C)
- REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.
- REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.
- REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.
- REGISTRATION: No platelet transfusions within 2 weeks of registration.
- REGISTRATION: No bleeding diathesis.
- REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL.
- REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL.
- REGISTRATION: Hemoglobin ≥ 9 g/dL.
- REGISTRATION: Platelet count ≥ 100,000/mcL.
- REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
- REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal [ULN] for people with documented Gilbert\'s disease).
- REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
- REGISTRATION: Albumin ≥ 2.8 g/dL.
- REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting...
- RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease defined by radiographic progression on...
- RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: people may be enrolled with chronic, stable...
- Chemotherapy-induced neuropathy
- Fatigue
- Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation...
- RE-REGISTRATION: None of the following conditions:
- Imminent or established spinal cord compression based on clinical and/or imaging findings.
- Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least...
- Corrected QT interval calculated by the Fridericia\'s formula (QTcF) \< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF.
- Significant cardiovascular defined as:
- Myocardial infarction within 6 months prior to enrollment.
- Uncontrolled angina pectoris within 6 months prior to enrollment.
- New York Heart Association Class 3 or 4 congestive heart failure.
- Uncontrolled hypertension (resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
- RE-REGISTRATION: ECOG Performance Status 0-2.
- RE-REGISTRATION: No GCSF within 2 weeks of registration.
- RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.
- RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.
- RE-REGISTRATION: WBC ≥ 2,500/mcL.
- RE-REGISTRATION: ANC ≥ 1,500/mcL.
- RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted).
- RE-REGISTRATION: Platelet count ≥ 100,000/mcL.
- RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
- RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for people with documented Gilbert\'s disease).
- RE-REGISTRATION: AST and ALT ≤ 3 x ULN.
- RE-REGISTRATION: Albumin ≥ 2.8 g/dL.
- RE-REGISTRATION: QT Interval (QTcF) \< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).
- RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Chico, California, United States
- Encinitas, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Orange, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Colorado Springs, Colorado, United States
- Fort Collins, Colorado, United States
- Greeley, Colorado, United States
- Loveland, Colorado, United States
- Stamford, Connecticut, United States
- Millville, Delaware, United States
- Newark, Delaware, United States
- Rehoboth Beach, Delaware, United States
- Jupiter, Florida, United States
- Honolulu, Hawaii, United States
- Coeur d'Alene, Idaho, United States
+ 73 more site(s).
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Tucson, Arizona, United States; Chico, California, United States; Encinitas, California, United States; Irvine, California, United States; La Jolla, California, United States and 87 more location(s). 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.