Prostate Cancer

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Phase 2 Open Label Study of Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) With or Without DNA Damage Repair Defects


Condition: Castration Resistant Prostatic Cancer, Metastatic Prostate Cancer

Intervention:

  • Drug: Pembrolizumab
  • Drug: Chemotherapy

Purpose: This is a multicenter phase 2 open label study of pembrolizumab in patients with metastatic castrate resistant prostate cancer (mCRPC) with or without DNA damage repair defects.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03248570

Sponsor: University of California, San Francisco

Primary Outcome Measures:

  • Measure: Objective response rate (ORR)
  • Time Frame: From baseline until complete response, progression on repeat pembrolizumab, or date of death from any cause, whichever comes first, up to 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Immune-related progression-free survival (irPFS)
  • Time Frame: At 20 weeks and 28 weeks
  • Safety Issue:
  • Measure: Progression-free survival (PFS)
  • Time Frame: At 20 weeks and 28 weeks
  • Safety Issue:
  • Measure: Proportion of subjects achieving any prostate specific antigen (PSA) response
  • Time Frame: From baseline until complete response, progression on repeat pembrolizumab, or date of death from any cause, whichever comes first, up to 24 months
  • Safety Issue:
  • Measure: Proportion of subjects achieving any PSA decline ≥ 50%
  • Time Frame: From baseline until complete response, progression on repeat pembrolizumab, or date of death from any cause, whichever comes first, up to 24 months
  • Safety Issue:
  • Measure: Safety of pembrolizumab
  • Time Frame: From baseline until 30 days after end of treatment (at complete response, progression on repeat pembrolizumab, or date of death from any cause, whichever comes first, up to 24 months)
  • Safety Issue:
  • Measure: Time to progression after taxane-based chemotherapy
  • Time Frame: From completion of taxane-based chemotherapy to progression, up to 24 months
  • Safety Issue:

Estimated Enrollment: 50

Study Start Date: February 20, 2018

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Histologically documented adenocarcinoma of the prostate.
  2. Metastatic castration resistant prostate cancer with castrate-level testosterone (<50 ng/dL). a. Subjects must maintain a castrate-level testosterone during the study.
  3. Disease progression defined by one or more of the following three criteria:
  4. PSA > 2.0 ng/mL and rising PSA by at least 2 consecutive measurements a minimum of 1-week apart.
  5. Soft tissue progression as defined by RECIST v1.1 criteria
  6. Bone disease progression as defined by Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
  7. Have measurable disease based on RECIST v.1.1 and irRC for response assessment. a. Must have at least one lesion that is 10mm in longest diameter for a soft tissue lesion or 15mm in short axis for a lymph node.
  8. Have received prior abiraterone and/or enzalutamide.
  9. Be willing and able to provide written informed consent/assent for the trial.
  10. Be ≥ 18 years of age on day of signing informed consent.
  11. Be willing to provide archival tissue from prior biopsy or surgery for prostate cancer, if available.
  12. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
  13. Patients must discontinue antiandrogen therapy (i.e. bicalutamide, flutamide, nilutamide) at least 4-6 weeks prior to registration with no evidence of PSA decline after washout.
  14. Bicalutamide: Washout period at least 6 weeks
  15. Flutamide and nilutamide: Washout period at least 4 weeks
  16. Patients must discontinue therapies for mCRPC, with the exception of Gonadotropin-releasing hormone (GnRH) agent, for 5 half-lives or 28 days, whichever is shorter.
  17. For patients on abiraterone/prednisone, prednisone should be discontinued for at least 7 days before starting study treatment.
  18. Prior chemotherapy is allowed if no progression of disease on chemotherapy.
  19. Prior treatment with sipuleucel-T, radium-223, or poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitor (e.g. olaparib) is allowed.
  20. Tissue biopsy may be performed during washout period.
  21. Demonstrate adequate organ function as defined as follows, all screening labs should be performed within 10 days of treatment initiation. a. Hematological i. Absolute neutrophil count (ANC): ≥ 1,500 /microliters (mcL) ii. Platelets: ≥ 100,000 / mcL iii. Hemoglobin: ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment) b. Renal i. Serum creatinine OR Measured or calculated a creatinine clearance (GFR can also be used in place of creatinine or CrCl): ≤ 1.5 X upper limit of normal (ULN) OR ≥ 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN c. Hepatic i. Serum total bilirubin: ≤ 1.5 X ULN ii. Aspartate Aminotransferase (AST) (SGOT) and Alanine Aminotransferase (ALT) (SGPT): ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases iii. Albumin: > 2.5 mg/dL d. Coagulation i. International Normalized Ratio (INR) or Prothrombin Time (PT): ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or Partial Thromboplastin Time (PTT) is within therapeutic range of intended use of anticoagulants ii. Activated Partial Thromboplastin Time (aPTT): ≤ 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  22. Male subjects of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Exclusion Criteria:

  1. Significant liver metastasis or disease-related bone pain requiring scheduled narcotics.
  2. Prior taxane-based chemotherapy with progressive disease on chemotherapy.
  3. Prior docetaxel for metastatic hormone sensitive prostate cancer is allowed, if no progression of disease on docetaxel as defined by RECIST v1.1 and PCWG
  4. Prior taxane-based chemotherapy (i.e. docetaxel or cabazitaxel with or without platinum agent) for mCRPC is allowed if no progression of disease on chemotherapy as defined by RECIST v1.1 and PCWG
  5. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  6. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy >10mg/day or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  7. Has a known history of active Bacillus Tuberculosis (TB).
  8. Hypersensitivity to pembrolizumab or any of its excipients.
  9. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  10. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  11. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  12. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  13. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  14. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  15. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy < 10 mg of prednisone/day for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  16. Has known history of, or any evidence of active, non-infectious pneumonitis.
  17. Has an active infection requiring systemic therapy.
  18. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  19. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  20. Is expecting to father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
  21. Has received prior therapy with an anti-programmed cell death protein 1 (PD-1), anti-PD-L1, or anti-PD-L2 agent.
  22. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  23. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., hepatitis C virus [HCV] RNA [qualitative] is detected).
  24. Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Contact:

  • Paula Dutton
  • 877-827-3222

Location:

  • UCSF Helen Diller Family Comprehensive Cancer Center
  • San Francisco California 94115 United States

View trial on ClinicalTrials.gov


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A Phase II Randomized, Open-Label, Two-Arm Study of a Low-Fat Diet With Fish Oil Capsules vs. a Control Group in Men on Active Surveillance for Prostate Cancer


Condition: Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Intervention:

  • Behavioral: behavioral dietary intervention
  • Behavioral: behavioral dietary intervention
  • Dietary Supplement: omega-3 fatty acid
  • Other: laboratory biomarker analysis

Purpose: This randomized phase II trial will evaluate if a low-fat diet with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02176902

Sponsor: Jonsson Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: Decipher score in one year prostate biopsy tissue sample
  • Time Frame: 1 year
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Composite measure: Prostate biopsy tissue markers of proliferation, cell cycle progression, and prostate biopsy pathologic features (Gleason grade, percent of cores with cancer, and percent of tissue with cancer)
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Serum PSA
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Composite measure: Long-term clinical outcomes (clinical progression, prostate cancer therapies)
  • Time Frame: Up to 15 years
  • Safety Issue:
  • Measure: Composite measure: Potential surrogate biomarkers of proliferation (RBC membrane fatty acid analyses, ex-vivo bioassay)
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Correlation of GPR120 expression in peripheral blood mononuclear cells (PBMCs) and prostate biopsy tissue with immunostaining of Ki67 and Decipher Score
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Compliance, defined as having taken 80% or more of the daily fish oil throughout the trial determined based on pill count
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Incidence of adverse events graded according to National Cancer Institute Common Toxicity Criteria version 4.0
  • Time Frame: Up to 1 year
  • Safety Issue:
  • Measure: Sample storage for future research
  • Time Frame: Up to 1 year
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: November 1, 2014

Eligibility:

  • Age: minimum 50 Years maximum 80 Years
  • Gender: Male

Inclusion Criteria:

  • Patients sign the informed consent
  • Patient had a prostate biopsy performed by Dr. Mark with the Artemis device and has adenocarcinoma of the prostate
  • Patient elects to undergo active surveillance
  • Clinical stage T2c or less
  • Gleason grade 3+4 or less
  • PSA < 20
  • Geographically able to have study visits at the University of California, Los Angeles (UCLA) Clinical Research Unit
  • Subjects are willing to not consume lycopene, green tea or pomegranate supplements or pomegranate juice during the 1-year study
  • If subjects are randomized to the control group they agree to not consume fish oil capsules during the 1-year study

Exclusion Criteria:

  • Diagnostic prostate biopsy with only 1 core with cancer and < 5% of tissue from that core involved with cancer
  • Patient has taken finasteride or dutasteride during the prior year
  • Patient has taken fish oil during the prior 3 months
  • Patient had prior treatment for prostate cancer (surgery, radiation, local ablative therapy, anti-androgen therapy or androgen deprivation therapy)
  • Patient has other medical conditions that exclude him from undergoing a repeat prostate biopsy at 1-year
  • Patient has allergy to fish

Location:

  • Jonsson Comprehensive Cancer Center
  • Los Angeles California 90095 United States

View trial on ClinicalTrials.gov


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PROVENT: A Randomised, Double Blind, Placebo Controlled Feasibility Study to Examine the Clinical Effectiveness of Aspirin and/or Vitamin D3 to Prevent Disease Progression in Men on Active Surveillance for Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Drug: High dose Aspirin & Vitamin D
  • Drug: High dose Aspirin, Vitamin D placebo
  • Drug: Low dose Aspirin , Vitamin D
  • Drug: Low dose Aspirin, Vitamin D placebo
  • Drug: Aspirin Placebo, Vitamin D
  • Drug: Aspirin placebo, Vitamin D placebo

Purpose: To demonstrate the acceptability and feasibility of recruitment to a randomised chemoprevention study of standard (300mg) or low dose (100mg) aspirin vs. placebo and/or Vitamin D3 vs. placebo in patients enrolled on an Active Surveillance programme for prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03103152

Sponsor: Queen Mary University of London

Primary Outcome Measures:

  • Measure: Rate of patient recruitment to a randomised chemoprevention study in men enrolled on an Active Surveillance programme for prostate cancer. Number accrued per month.
  • Time Frame: 18 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Response to treatment as determined by serial multi-parametric magnetic resonance imaging (MRI) of the prostate. New lesion present or existing lesion + or - in size.
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Biochemical disease progression. 50% increase in serum Prostate Specific Antigen at 12 months from baseline.
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Histological disease progression. Increase in Gleason score or MCCL
  • Time Frame: 3 years
  • Safety Issue:
  • Measure: Toxicity and/or allergy to both aspirin and Vitamin D3; Symptoms of Aspirin or Vit D toxicity.
  • Time Frame: 3 years
  • Safety Issue:

Estimated Enrollment: 102

Study Start Date: December 2016

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum 16 Years maximum 100 Years
  • Gender: Male

Inclusion Criteria:

  • 1. Male subjects aged 16 years or over with an estimated life expectancy of more than three years 2. Willing and able to provide written informed consent 3. Corrected serum calcium <2.65mmol/l 4. No previous treatment for prostate cancer (including surgery, hormone therapy, radiotherapy, cryotherapy) 5. All subjects must have had Magnetic Resonance Imaging (MRI) of the prostate with targeted biopsy of any lesions identified 6. Histologically confirmed prostate cancer* following prostate biopsy (including at least 10 cores of prostate tissue) in men opting for Active Surveillance as their primary cancer therapy.
  • *PROVENT Prostate Cancer Criteria for Inclusion:
  • Gleason score 6 or 7
  • Clinical and radiological stage
  • Serum PSA ≤15.0 ng/ml
  • Less than 10mm of cancer in a single core Patients must have undergone a multi-parametric MRI deemed assessable by the local radiologist, and any lesions seen must have undergone targeted biopsy (transrectal or transperineal) within 12 months of study enrolment.

Exclusion Criteria:

  1. Previously treated prostate cancer (including radiotherapy, hormone therapy, brachytherapy or surgery)
  2. Current enrolment in an investigational drug, device or other clinical research study or participation in such a study within 30 days of randomisation
  3. Current daily use of aspirin or NSAIDs; or daily dietary supplements/medication containing more than 400 IU (10 micrograms per day) Vitamin D3; or chronic use (defined as > 6 months continuous daily use) of either aspirin or replacement Vitamin D3 within two years of study enrolment
  4. Current or previous use of 5-α reductase inhibitors such as finasteride or dutasteride
  5. Not willing to comply with the procedural requirements of this protocol including repeat prostate biopsies
  6. Known allergy/sensitivity to or intolerance of aspirin, other salicylates or NSAIDs e.g. ibuprofen/ naproxen
  7. Prior history of gastro-intestinal bleeding or ulceration, severe dyspepsia or inflammatory bowel disease
  8. Haemophilia or other bleeding diatheses
  9. Prior history of renal stone disease
  10. Chronic renal disease (≥stage 4)
  11. Known hypercalcaemia (corrected serum calcium >2.65 mmol/l) or untreated hyperparathyroidism
  12. Any bowel condition that would make repeat transrectal biopsy hazardous or difficult to perform e.g. recto-urethral fistula, or prior bowel surgery such as abdomino-perineal resection.
  13. Any malignancy (other than non-melanoma skin cancer) that has not been in complete remission for five years
  14. Any serious co-existent medical condition that would make repeat prostate biopsy hazardous e.g. anti-coagulation requiring continuous administration
  15. Severe Asthma
  16. G6PD deficiency
  17. Pre-existing macular degeneration
  18. All contraindications to aspirin and Vitamin D3, including concomitant therapy with any medication that may interact with aspirin or Vitamin D3 (see section 4.10)
  19. Regular consumption of alcohol units greater than the recommended daily limit of 3-4 units per day (men)

Contact:

  • Thomas Powles, MD
  • 0207 882 8498

Locations:

  • University Hospital of Wales
  • London CF14 4XW United Kingdom
  • University Hospital UHCW NHS Trust
  • London CV2 2DX United Kingdom
  • St Bartholomews Hospital London, Bart's and the London school of Medicine
  • London EC1A 7BE United Kingdom
  • University College Hospital London
  • London NW1 2B United Kingdom
  • Guy's Hospital
  • London United Kingdom
  • Homerton Hospital
  • London United Kingdom

View trial on ClinicalTrials.gov


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Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Dietary Supplement: Vitamin D
  • Dietary Supplement: Omega-3
  • Dietary Supplement: Turmeric

Purpose: The purpose of this study is to see if eating vitamin D, omega 3 and turmeric (curcumin) slows the growth of prostate cancer in men on active surveillance.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03290417

Sponsor: Case Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: gene expression of very low and low risk prostate cancer patients on Active Surveillance
  • Time Frame: Up to 6 months
  • Safety Issue:
  • Measure: gene expression of very low and low risk prostate cancer patients on Active Surveillance
  • Time Frame: Up to 12 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Active Surveillance Failure
  • Time Frame: Up to 12 months
  • Safety Issue:
  • Measure: Time to Active Surveillance Failure
  • Time Frame: Up to 12 months
  • Safety Issue:

Estimated Enrollment: 75

Study Start Date: September 7, 2017

Eligibility:

  • Age: minimum N/A maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Subjects must have the diagnosis of prostate cancer and be on active surveillance. For the purpose of this study, Active surveillance implies prostate-specific antigen (PSA)<10 ng/mL, biopsy Gleason sum
  • Subjects must be followed at the Cleveland Clinic for active surveillance.
  • Subjects must be willing to adhere to the dietary modification outlined in the protocol.
  • Subjects must be willing to have prostate biopsies at the baseline, and six months after enrollment into the protocol
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Subjects receiving any treatment other than AS for prostate cancer.
  • Subjects not followed by the Cleveland Clinic.
  • Subjects unable to adhere to the dietary modification outlined in the protocol.

Contact:

  • David Levy, MD
  • 216-990-8011

Location:

  • Cleveland Clinic, Case Comprehensive Cancer Center
  • Cleveland Ohio 44195 United States

View trial on ClinicalTrials.gov


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A Phase 2 Study of Apalutamide in Active Surveillance Patients


Condition: Stage II Prostate Adenocarcinoma AJCC v7

Intervention:

  • Drug: Apalutamide
  • Other: Laboratory Biomarker Analysis
  • Other: Quality-of-Life Assessment

Purpose: This phase II trial studies how well apalutamide works in treating patients with prostate cancer who are in active surveillance. Testosterone can cause the growth of prostate cancer cells. Hormone therapy using androgen receptor antagonist apalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02721979

Sponsor: University of Washington

Primary Outcome Measures:

  • Measure: Negative (i.e. no residual carcinoma) site directed and systematic prostate biopsy rate
  • Time Frame: At 90 days
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Alteration in MYC/chromosome 8q24 via fluorescence in situ hybridization
  • Time Frame: Baseline to up to 91 days
  • Safety Issue:
  • Measure: Change in quality of life as assessed using the Functional Assessment of Cancer Therapy-Prostate surveys
  • Time Frame: Baseline to up to 730 days
  • Safety Issue:
  • Measure: Change in quality of life as assessed using the Short Form-36 survey
  • Time Frame: Baseline to up to 730 days
  • Safety Issue:
  • Measure: Change in radiographic disappearance of magnetic resonance imaging detectable prostate cancer
  • Time Frame: Baseline to up to 90 days
  • Safety Issue:
  • Measure: Incidence of adverse events
  • Time Frame: Up to 730 days
  • Safety Issue:
  • Measure: Local treatment free survival
  • Time Frame: Up to 730 days
  • Safety Issue:
  • Measure: Percent of men undergoing of local treatment
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: Percentage of patients exiting active surveillance due to pathologic reclassification
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: Percentage of patients exiting active surveillance for any reason
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: Phosphatase and tensin homolog (PTEN) fluorescence in situ hybridization
  • Time Frame: Baseline to up to 91 days
  • Safety Issue:
  • Measure: Prostate-specific antigen progression free survival as defined by the Prostate Cancer Working Group 2 criteria
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: Prostate-specific antigen progression rate as defined by the Prostate Cancer Working Group 2 criteria (i.e. confirmed rising prostate-specific antigen >= 2 ng/mL at least one week apart)
  • Time Frame: At 2 years
  • Safety Issue:
  • Measure: PTEN immunohistochemistry
  • Time Frame: Baseline to up to 91 days
  • Safety Issue:
  • Measure: Severity of adverse events
  • Time Frame: Up to 730 days
  • Safety Issue:
  • Measure: Tumor messenger ribonucleic acid expression profiling/risk classification (e.g. Decipher or ribonucleic acid-seq)
  • Time Frame: Baseline to up to 91 days
  • Safety Issue:

Estimated Enrollment: 33

Study Start Date: November 2, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  • Have signed an informed consent document
  • Be willing/able to adhere to the prohibitions and restrictions specified in this protocol
  • Written authorization for use and release of health and research study information has been obtained
  • Life expectancy >= 10 years (as determined by the treating physician)
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1
  • Histologically confirmed adenocarcinoma of the prostate as documented by a minimum 12 core prostate biopsy completed within 1-year of enrollment (note: most recent prostate biopsy must have demonstrated prostatic adenocarcinoma)
  • Favorable risk prostate cancer as defined by:
  • Very low-risk:
  • Clinical stage T1c disease
  • PSA density (PSAD) < 0.15 ng/mL
  • Gleason score 6
  • =< 2 core biopsies with =< 50% involvement of any biopsy core with cancer, or unilateral disease =< 2 core biopsies with any percentage involvement OR
  • Low risk:
  • Clinical stage =< T2a
  • PSA < 10 ng/mL
  • Gleason score 6 OR
  • Low-intermediate risk:
  • Clinical stage T1c
  • PSA < 10 ng/ml
  • Gleason 3+4 present in =< 50% of one core/site as detected by systematic biopsy or MRI/transrectal ultrasound (TRUS) fusion guided biopsy
  • Gleason 6 disease in all other cores (maximum of 2 cores with =< 50% involvement of any core, or if unilateral disease, any percentage involvement)
  • Willing and qualified for active surveillance at Johns Hopkins or the University of Washington
  • Serum testosterone >= 150 ng/dL
  • Able to swallow the study drugs whole as a tablet
  • Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
  • Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
  • Serum albumin >= 3.0 g/dL
  • Glomerular filtration rate (GFR) >= 45 mL/min
  • Serum potassium >= 3.5 mmol/L
  • Serum total bilirubin =< 1.5 x upper limit of normal (ULN) (note: in subjects with Gilbert's syndrome, if total bilirubin is > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =< 1.5 x ULN, subject may be eligible)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 × ULN
  • Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug; must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

Exclusion Criteria:

  • Prior local therapy to treat prostate cancer (e.g. radical prostatectomy, radiation therapy, brachytherapy)
  • Prior use of ARN-509 (apalutamide)
  • Have known allergies, hypersensitivity, or intolerance to ARN-509 (apalutamide) or its excipients
  • Prior or ongoing systemic therapy for prostate cancer including, but not limited to:
  • Hormonal therapy (e.g. leuprolide, goserelin, triptorelin)
  • Cytochrome P450 (CYP)-17 inhibitors (e.g. abiraterone, ketoconazole)
  • Antiandrogens (e.g. bicalutamide, nilutamide)
  • Second generation antiandrogens (e.g. enzalutamide)
  • Immunotherapy (e.g. sipuleucel-T, ipilimumab)
  • Chemotherapy (e.g. docetaxel, cabazitaxel)
  • Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
  • History of any of the following:
  • Seizure or known condition that may pre-dispose to seizure (including but not limited to prior stroke, transient ischemic attack, loss of consciousness within 1 year prior to randomization, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  • Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
  • Any condition that in the opinion of the investigator, would preclude participation in this study
  • Current evidence of any of the following:
  • Uncontrolled hypertension
  • Gastrointestinal disorder affecting absorption
  • Active infection (e.g. human immunodeficiency virus [HIV] or viral hepatitis) or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated
  • Any condition that in the opinion of the investigator, would preclude participation in this study
  • The use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
  • The use of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors, including: itraconazole, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice (or grapefruits)
  • Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
  • Strong CYP3A4 inducers, including: phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, efavirenz, tipranavir, St. John's wort
  • Note: If a patient is on a strong CYP3A4 inhibitor, they can be reconsidered for enrollment if they can safely stop said medication; a two week or 5 half-lives, whichever is longer, washout will be required prior to enrolling on study; subject may not resume medication while receiving apalutamide
  • Any psychological, familial, sociological, or geographical condition that could potentially interfere with compliance with the study protocol and follow-up schedule

Locations:

  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Baltimore Maryland 21287 United States
  • Fred Hutch/University of Washington Cancer Consortium
  • Seattle Washington 98109 United States

View trial on ClinicalTrials.gov


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A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer


Condition: Metastatic Castrate-resistant Prostate (CRPC) Cancer

Intervention:

  • Drug: ODM-201
  • Drug: Enzalutamide

Purpose: To assess patient preference between ODM-201 and enzalutamide by patient preference questionnaire

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03314324

Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Primary Outcome Measures:

  • Measure: Patient preference
  • Time Frame: up to 24 months
  • Safety Issue:

Estimated Enrollment: 250

Study Start Date: November 29, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Male patients older than 18 years
  • Histologically confirmed adenocarcinoma of the prostate
  • Evidence of metastatic disease (imaging can include bon scan, CT scan, PET choline, PET PSMA and MRI)
  • Continued androgen deprivation therapy (ADT) either with LHRH agonists/antagonists or bilateral orchiectomy
  • Serum testosterone <0.50 ng/ml (1.7 nmol/L)
  • Progressive disease (PSA progression or radiological progression or clinical progression) as per PCWG3 criteria
  • ECOG 0-1 (2 is accepted if the impairement is not due to prostate cancer)
  • Asymptomatic or mildly symptomatic (Brief Pain Inventory<4) prostate cancer
  • Information imparted to the patient and the informed consent form signed by the patient or his legal representative
  • Ability to comply with the protocol procedures
  • Patient affiliated to a social security system or beneficiary of the same
  • Sexually active male subjects unless surgically sterile, must agree to use condoms as an effective barrier method and refrain from sperm donation, and/or their female partners of reproductive potential to use a method of effective birth control, during the study treatment and for 3 months after the end of the treatment
  • adequate organ or bone marrow function as evidenced by:
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1.5 x 109/L,
  • Platelet count ≥ 100 x 109/L, (subject must not have received any growth factor within 4 weeks or blood transfusion within 7 days of the hematology laboratory sample obtained at screening)
  • AST/SGOT and/or ALT/SGPT ≤1.5 x ULN;
  • Total bilirubin ≤ 1.5 x ULN, (except subjects with a diagnosis of Gilbert's disease),
  • Serum creatinine ≤ 2 x ULN. If creatinine 1.0
  • 1.5 x ULN, creatinine clearance will be calculated according to the CKDEPI formula and patients with creatinine clearance <60 mL/min should be excluded.

Exclusion Criteria:

  • Prior treatment with abiraterone, enzalutamide, ODM-201, ARN- 509 or any other next-generation AR axis-targeting drug
  • Prior treatment with a taxane for CRPC (prior treatment with a taxane for castration-sensitive or castration-naïve prostate cancer is allowed)
  • Prior treatment with radium-223
  • Patients receiving an investigational drug within 4 weeks prior to enrolment (approved drugs with a long history of use such as aspirin, statins, heparins, or metformin, even used in an experimental setting are accepted)
  • Treatment with radiotherapy (external beam radiation therapy [EBRT], brachytherapy, or radiopharmaceuticals) within 2 weeks before randomization
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation of the study drugs
  • Acute toxicities of prior treatments and procedures not resolved to grade <=1 or baseline before randomisation.
  • Had any of the following within 6 months before randomization: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, congestive heart failure (New York Heart Association (NYHA) Class III or IV)
  • Uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg despite optimal medical management
  • Had a prior malignancy. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any other cancer for which treatment has been completed ≥5 years before randomization and from which the subject has been disease-free
  • A gastrointestinal disorder or procedure which is expected to interfere significantly with absorption of study treatment
  • An active viral hepatitis, active human immunodeficiency infection(HIV), or chronic liver disease with a need for treatment.
  • Any other serious or unstable illness or infection, or medical, social, or psychological condition, that could jeopardize the safety of the subject and/or his compliance with study procedures, or may interfere with the subject's participation in the study or evaluation of the study results
  • Inability to swallow oral medications

Contact:

  • Karim FIZAZI, MD, PhD
  • 0142114317 Ext. +33

Location:

  • Gustave Roussy
  • Villejuif Val De Marne 94805 France

View trial on ClinicalTrials.gov


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The Role of Androgen Deprivation Therapy In Cardiovascular Disease - A Longitudinal Prostate Cancer Study (RADICAL PC1) & A RAndomizeD Intervention for Cardiovascular and Lifestyle Risk Factors in Prostate Cancer Patients (RADICAL PC2)


Condition: Prostate Cancer, Cardiovascular Disease

Intervention:

  • Behavioral: Nutrition
  • Behavioral: Exercise
  • Behavioral: Smoking cessation
  • Drug: Antiplatelet agent, such as Aspirin, or other low-dose antiplatelet agent
  • Drug: Statin, such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)
  • Drug: ACE inhibitor

Purpose: RADICAL PC1 is a prospective cohort study of men with a new diagnosis of prostate cancer. RADICAL PC2 is a randomized, controlled trial of a systematic approach to modifying cardiovascular and lifestyle risk factors in men with a new diagnosis of prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03127631

Sponsor: McMaster University

Primary Outcome Measures:

  • Measure: Primary Efficacy Outcome - Composite of Death, MI, Stroke, HF, or Arterial Revasc.
  • Time Frame: 3-5 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke or HF.
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Composite of Death, MI, Stroke, HF, A. Revasc, or Angina.
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - CV Death
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Myocardial Infarction
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Stroke
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Heart Failure
  • Time Frame: 3-5 years
  • Safety Issue:
  • Measure: Secondary Efficacy Outcome - Event Outcome - Venous Thromboembolism
  • Time Frame: 3-5 years
  • Safety Issue:

Estimated Enrollment: 6000

Study Start Date: October 2015

Eligibility:

  • Age: minimum 45 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 1. A man with a diagnosis of prostate cancer that is either:
  • new (i.e. the diagnosis was made within 1 year of the baseline visit) or
  • treated with Androgen Deprivation Therapy for the first time within 1 month prior to the baseline visit, or
  • to be treated with Androgen Deprivation Therapy for the first time within 1 month after the baseline visit

Exclusion Criteria:

  • 1. Unwilling to provide consent, or 2. Are <45 years of age 3. Patients will be eligible for RADICAL PC1, but will not be eligible for RADICAL PC2 if they:
  • see a cardiologist every year, or
  • are undertaking all of the following:
  • aspirin use, and
  • statin use, and
  • ACE-I use, and
  • exercise 4 or more times per week

Contact:

  • Kayla Pohl, BA, CCRP
  • 905-527-4322 Ext. 40694

Locations:

  • William Osler Health System
  • Brampton Ontario L6R 3J7 Canada
  • St. Joseph's Healthcare
  • Hamilton Ontario L8N4A6 Canada
  • Juravinski Cancer Centre
  • Hamilton Ontario L8V1C3 Canada
  • Queen's University
  • Kingston Ontario K7L 3J7 Canada
  • London Health Sciences Centre
  • London Ontario N6A 5W9 Canada
  • Ottawa Hospital Research Institute
  • Ottawa Ontario K1H 8L6 Canada
  • Sunnybrook Health Sciences Centre
  • Toronto Ontario M4N 3M5 Canada
  • University Hospital of Montreal
  • Montreal Quebec H2X 0A9 Canada
  • Jewish General Hospital
  • Montreal Quebec H3T 1E2 Canada
  • Laval University
  • Quebec City Quebec G1V 0A6 Canada

View trial on ClinicalTrials.gov


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