Physician

Neil Belman, DO

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

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This is a Phase 2 study evaluating the efficacy of a CDK, PI3K, or NTRK/ROS1 inhibitor in patients with progressive brain metastases from solid tumors harboring the alterations predicting sensitivity to each of these inhibitors.

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• Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor

• Tissue must be available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If extracranial tissue is not available or there is no evidence of extracrania disease, brain metastasis tissue is sufficient for eligibility

• Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy

• Patients must be able to undergo MRI with contrast

• Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review

• For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting

• For TNBC, patients must have had at least one chemotherpy in the metastatic setting

• For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting

• For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease

• For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease

• No known current diffuse leptomeningeal involvement

• No surgery within 2 weeks prior to or after registration

• No chemotherapy within 14 days prior to registration

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Physician

William Smith, MD

Study Coordinator

Helen McGunnigle
email: Helen.McGunnigle@sluhn.org
phone: 484-658-5044

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The purpose of this research study is to learn which treatment approaches are better, similar, or worse than the usual approach for high-risk prostate cancer. The usual approach is treatment with hormonal drugs and radiation therapy. As a part of this study, tumor tissue from your prostate cancer will be sent for Decipher Analysis. This test will give a gene risk score of 0 to 1.0. In this study, a score of 0.85 or below will be considered low risk, and greater than 0.85 will be considered high risk. The treatment assigned while on the study will be determined by this risk score. For a low risk score, the treatment options will include the usual hormone drugs for either 12 or 24 months and radiation therapy. For a high risk score, the treatment options will include the usual hormone drugs for 24 months and radiation therapy with or without the addition of a study drug called apalutamide.

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Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

• Pathologically proven adenocarcinoma of the prostate by biopsy within 180 days prior to registration

High-risk disease defined as having at least one or more of the following:

• PSA > 20 ng/mL prior to starting ADT
• cT3a-T4 by digital rectal exam or imaging
• Gleason Score of 8-10
• Node positive by conventional imaging with a short axis of at least 1.0 cm
• MANDATORY Decipher Analysis submission is required for stratification
• ECOG 0-2
• Patients must not have evidence of metastatic disease, systemic chemotherapy within 3 years prior to registration, radical prostatectomy or prior RT to the region of the study cancer
• Current use of 5-alpha reductase inhibitors is prohibited

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Physician

William Smith, MD

Study Coordinator

Helen McGunnigle
email: Helen.McGunnigle@sluhn.org
phone: 484-658-5044

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As part of this study, tumor tissue from your prostate cancer will be sent for Decipher Analysis. This test will give a gene risk score of 0 to 1.0. For those patients with lower risk score, < 0.40, and unfavorable intermediate risk prostate cancer, the study will help determine if radiation alone is as effective at controlling your cancer compared to the usual combination of radiation and hormone therapy. For those patients with higher risk score, ≥ 0.40, and unfavorable intermediate risk prostate cancer, the study will help determine if adding a new hormone therapy drug to the usual combination of radiation and hormone therapy increases the length of time without your prostate cancer spreading compared to the usual treatment.

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Pathologically proven adenocarcinoma of the prostate by biopsy within 365 prior to registration.

Unfavorable intermediate risk defined as having ALL the following bulleted criteria.

At least one of the following intermediate risk factors:

• PSA 10-20 ng/mL
• Clinical stage T2b-c (DRE and/or imaging) by AJCC 8th edition
• Gleason Score 7 (Gleason 3+4 or 4+3 [ISUP Grade Group 2-3])

Has ONE or more of the following 'unfavorable' intermediate-risk designators:

• >1 IRF
• Gleason 4+3=7 (ISUP Grade Group 3)
• ≥ 50% of biopsy cores positive
• Absence of high-risk features
• MANDATORY Decipher Analysis submission is required for stratification
• ECOG performance status 0-2
• Non-castrate testosterone level (> 50 ng/dL) within 120 days prior to registration
• Prior prostatectomy or any form of curative-intent ablation whether focal or whole-gland for prostate cancer is not allowed
• Previous hormonal therapy, such as LHRH agonists or LHRH antagonists are not allowed. ADT started prior to study registration is not allowed

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