Location: Cleveland, OH

Indication: Prostate Cancer

Sponsor: Clovis Oncology, Inc.

PI: Lawrence Gervasi, MD

Phase: 3

Ages: 18+

Compensation: You may be compensated for your time and participation.

Criteria:

• Must have metastatic castrate-resistant prostate cancer with progression.
• Must be on ADT and show progression with at least 2 rising PSA.
• No prior Chemotherapy is permitted.
• Must have a gene mutation such as BRCA 1/BRCA 2.

About: A Multicenter, Randomized, Open-label Phase 3 Study of Rucaparib versus Physician’s Choice of Therapy for Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency.

Location: Cleveland, OH

Indication: Prostate Cancer

Sponsor: Mana RBM

PI: Lawrence Gervasi, MD

Phase: A Phase III Randomized Study Comparing Xtandi or Nubeqa with Radium-223 vs Xtandi or Nubeqa with Placebo and the Effect upon Symptomatic Skeletal Event-Free Survival for mCRPC Patients

Ages: 18+

Criteria:

• Patients with metastatic prostate cancer with progression
• Patients currently taking ADT (androgen deprivation therapy).
• Patients CANNOT have received Radium-255 or chemotherapy prior except for docetaxel for hormone-sensitive disease with a maximum of 6 cycles.
• Patients CANNOT have prior treatment with Abiraterone, Apalutamide, Darolutamide, or Enzalutamide for greater than 2 months.

Compensation: $50.00 for Visits, all study related procedure and medication is provided to the patient at no cost.

About: Studying Xtandi (enzalutamide) or Nubeqa (darolutamide) followed by Xofigo (radium-223) or Placebo (saltwater) as a possible treatment for metastatic castration-resistant prostate cancer (mCRPC).

Location: Cleveland, OH

Indication: Prostate Cancer

Sponsor: Hinova Pharmaceuticals USA Inc.

PI: Lawrence Gervasi, MD

Intervention/Treatment: Oral HC-1119 Versus Enzalutamide

Phase: 3

Ages: 18+

Criteria:

• Male

• Histologically or cytologically confirmed adenocarcinoma of the prostate without significant and relevant neuroendocrine differentiation or small cell features, per investigator’s judgment.
• NO Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Compensation: You may be compensated for your time and participation

About: This study is a multinational Phase 3, randomized, double-blind, non-inferiority, efficacy, and safety study of oral HC-1119 (80 mg/day) versus enzalutamide (160 mg/day) in asymptomatic or mildly symptomatic patients with progressive metastatic castration-resistant prostate cancer (mCRPC).

Location:  Cleveland, OH

Indication:  Prostate Cancer

Sponsor: Myovant Sciences

PI: Lawrence Gervasi, MD

Intervention/Treatment: Relugolix in combination with Abiraterone plus Prednisone

Ages: 18+

Criteria:

• Male

• A diagnosis of adenocarcinoma of the prostate confirmed by histologic or cytologic evidence and with a documented medical history
• Currently receiving standard-of-care treatment of leuprolide acetate (3-, 4-, or 6-month injections [intramuscular Lupron or subcutaneous Eligard]) or a gonadotropin-releasing hormone (GnRH) receptor antagonist (such as degarelix) in combination with:
  • Part 1: abiraterone acetate 1000 mg or fine-particle abiraterone acetate 500 mg once daily plus prednisone 5 mg once daily for participants with mCSPC or twice daily for participants with mCRPC or methylprednisolone 4 mg once daily and in whom abiraterone has been well-tolerated (that is, without evidence of hepatotoxicity requiring dose adjustment for abiraterone) for a minimum of 12 weeks prior to initiation of the study treatment period.
  • Part 2: apalutamide 240 mg once daily and in whom apalutamide has been well-tolerated (that is, without a fracture, fall, or seizure episode or need to dose adjust due to any adverse events) for a minimum of 6 weeks prior to initiation of the study treatment period.
  • Part 3: docetaxel 75 mg/m2 and in whom docetaxel has been well-tolerated (that is, no evidence of hypersensitivity reaction, febrile neutropenia or neutrophils < 500 cells/mm3 for more than 1 week, severe or cumulative cutaneous reactions, or moderate neurosensory signs and/or symptoms despite dose reduction) for a minimum of 1 previous treatment cycle.
• NO Abnormal clinical laboratory test value(s) suggestive of clinically unstable underlying disease or a clinical laboratory test value(s) at the screening visit or prior to the baseline (Day 1) visit

Compensation: You may be compensated for your time and participation

About: This study is being conducted to assess the safety and tolerability of relugolix with other agents approved for use in combination with androgen deprivation therapy (ADT) for a 12-week treatment period and an additional 40-week safety extension period in men with prostate cancer, either metastatic castration-sensitive prostate cancer (mCSPC) or non-metastatic or metastatic castration-resistant prostate cancer (nmCRPC or mCRPC).

Location:  Cleveland, OH

Indication:  Prostate Cancer

Sponsor: Very, Inc

PI: Lawrence Gervasi, MD

Intervention/Treatment: VERU-111 (Sabizabulin)

Phase: 3

Ages: 18 – 100

Criteria:

• Male

• Histological or cytologic proof of adenocarcinoma of the prostate not including the diagnosis of small cell carcinoma of the prostate of neuroendocrine pathology.
• Radiographic evidence of metastatic disease at baseline by CT scan, or MRI and bone scan, with confirmation of measurable disease by RECIST 1.1 and/or identifiable discrete bone metastases by PCWG3.
• Known castration resistant prostate cancer, defined according to PCWG3 criteria.
• Have received at least one androgen receptor targeting agent (e.g. abiraterone, enzalutamide, darolutamide, or apalutamide).

• NO Known hypersensitivity or allergy to colchicine.
• NO Histologic identification of small cell carcinoma of the prostate or neuroendocrine pathology in either biopsy or prostatectomy tissue.

Compensation: You may be compensated for your time and participation

About: To demonstrate the efficacy of VERU-111 (Sabizabulin) in the treatment of metastatic castration-resistant prostate cancer in patients who have failed prior treatment with at least one androgen receptor targeting agent as measured by radiographic progression-free survival.

Location:  Cleveland, OH

Indication:  Prostate Cancer

Sponsor: Pfizer

PI: Lawrence Gervasi, MD

Intervention/Treatment: Talazoparib plus enzalutamide or placebo plus enzalutamide

Phase: 3

Ages: 18+

Criteria:

• Male

• Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features. If the participant does not have a prior histological diagnosis, a baseline de novo biopsy must be used to confirm the diagnosis and may also be used to support biomarker analysis.
• Confirmation of DDR gene mutation status by prospective or historical analysis (with sponsor pre-approval) of blood (liquid biopsy) and/or de novo or archival tumor tissue using FoundationOne Liquid CDx or FoundationOne CDx.
• NO other acute or chronic medical (concurrent disease, infection or co-morbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that interferes with a participant’s ability to participate in the study, may increase the risk of associated with study participation or study treatment administration, or may interfere with the interpretation of study results, and, in the investigator’s judgment, make the participant inappropriate for entry into the study.
• NO history of seizure or any condition (as assessed by investigator) that may predispose to seizure (eg, prior cortical stroke, significant brain trauma), including any history of loss of consciousness or transient ischemic attack within 12 months of randomization.
• NO major surgery (as defined by the investigator) within 2 weeks before randomization.

Compensation: You may be compensated for your time and participation

About: The purpose of the study is to evaluate the safety and efficacy of talazoparib in combination with enzalutamide compared with placebo in combination with enzalutamide in participants with DDR-deficient mCSPC. The study will have 5 periods: prescreening, screening, double-blind treatment, safety follow-up, and long-term follow-up.

Location:  Cleveland, OH

Indication:  Prostate Cancer

Sponsor: Very, Inc.

PI: Lawrence Gervasi, MD

Intervention/Treatment: VERU-100

Ages: 18 – 100

Criteria:

• Male

• Have histologically confirmed prostate cancer
• NOT received chemotherapy, cryotherapy, or antiandrogen therapy within 8 weeks prior to the Screening visit for the treatment of prostate cancer.

• NO major surgery within 4 weeks of Screening Visit (including surgery for prostate cancer)

Compensation: You may be compensated for your time and participation

About: To determine an effective dose of VERU-100 for the treatment of advanced prostate cancer by assessing its effect on testosterone levels by Day 28 and maintenance through Day 91.

Location:  Cleveland, OH

Indication:  Longitudinal Prostate Cancer

Sponsor: MT Group

PI: Lawrence Gervasi, MD

Intervention/Treatment: Blood sample collection

Ages: 18+

Criteria:

• Male
• The patient must be diagnosed with histologically confirmed adenocarcinoma of the prostate
• Patients must have radiographic measurable evidence of metastatic disease (i.e lesion(s) in bone, soft tissue, or visceral metastases)
• NO Patients diagnosed with small cell or neuroendocrine tumors of the prostate
• NO prior radiation therapy within 2 weeks prior to the start of study treatment.

Compensation: You may be compensated for your time and participation

About: Study of Fresh Blood from patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) at multiple time points.