Prostate Cancer

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A Randomized Controlled Trial of ProstAtak® as Adjuvant to Up-front Radiation Therapy For Localized Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Biological: ProstAtak®(AdV-tk) + valacyclovir
  • Biological: Placebo + valacyclovir

Purpose: The purpose of this study is to evaluate the effectiveness of ProstAtak® immunotherapy in combination with radiation therapy for patients with intermediate-high risk localized prostate cancer. ProstAtak kills tumor cells and stimulates a cancer vaccine effect. Killing tumor cells in an immune stimulatory environment induces the body's immune system to detect and destroy cancer cells. ProstAtak has shown synergy with radiation without added toxicity and lower than expected recurrence rates in previous clinical trials. The hypothesis is that ProstAtak can lead to improvement in the clinical outcome for patients with prostate cancer. Participants will be randomized to the ProstAtak or control arm at a 2:1 ratio. Both arms receive standard external beam radiation therapy. Short-term androgen deprivation therapy may be given but is not required.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01436968

Sponsor: Advantagene, Inc.

Primary Outcome Measures:

  • Measure: Disease free survival defined as the time from randomization until the date of the first failure event will be compared for the ProstAtak® arm versus the placebo control arm. The analyses will be based on the intent to treat population.
  • Time Frame: Assessed at each visit every 6 months through year 5 until event occurs.
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Prostate cancer specific survival and overall survival will be compared for the ProstAtak® arm versus the placebo control arm.
  • Time Frame: Assessed at each visit every 6 months through year 5 after which long-term follow up of general health status will continue yearly.
  • Safety Issue:
  • Measure: PSA nadir will be compared for the ProstAtak® arm versus the placebo control arm.
  • Time Frame: Assessed at each visit every 6 months through year 5.
  • Safety Issue:
  • Measure: Patient reported Health Related Quality of Life outcomes will be collected using the Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire. The change in QOL over time will be compared for the ProstAtak® arm versus the placebo control arm.
  • Time Frame: Assessed at baseline and at 3, 6, 12, 18 and 24 months after completion of radiation.
  • Safety Issue:
  • Measure: The safety profile will be characterized by collection of adverse event information and laboratory values during the treatment phase (until the completion of radiation). Data on late effects will be collected after radiation completion.
  • Time Frame: Assessed at each visit and continuously throughout the study.
  • Safety Issue:

Estimated Enrollment: 711

Study Start Date: September 2011

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • include:
  • Localized prostate cancer meeting the NCCN criteria of Intermediate Risk or patients having only one NCCN high-risk feature
  • NCCN Intermediate Risk is defined as having at least one of the following: PSA 10-20 ng/ml, Gleason score =7, T2b-T2c
  • High Risk with a single high risk feature is defined as having only one of the following: PSA>20 ng/ml, Gleason score 8-10, or T3a
  • Excluded are those in the following risk groups: Low risk; High risk with more than 1 high risk factor; Locally advanced/very high risk=T3b-T4; Metastatic: N1 or M1
  • Planning to undergo standard prostate-only external beam radiation therapy
  • ECOG Performance Status 0-2

Exclusion Criteria:

  • include:
  • Liver disease, including known cirrhosis or active hepatitis
  • Patients on systemic corticosteroids (>10mg prednisone per day) or other immunosuppressive drugs
  • Known HIV+ patients
  • Regional lymph node involvement or distant metastases
  • Patients planning to receive whole pelvic irradiation
  • Prior treatment for prostate cancer, except TURP or ADT. For ADT, it may only be given for a maximum of 6 months
  • Patients who had or plan to have orchiectomy as the form of hormonal ablation
  • Known sensitivity or allergic reactions to acyclovir or valacyclovir

Locations:

  • Arizona Oncology Services Foundation
  • Multiple Locations Arizona 85260 United States
  • Precision Radiation Oncology
  • Tustin California 92780 United States
  • Foothills Urology
  • Golden Colorado 80401 United States
  • Advanced Urology
  • Parker Colorado 80134 United States
  • Sibley Memorial Hospital
  • Washington District of Columbia 20016 United States
  • The Johns Hopkins University School of Medicine, The Sidney Kimmel Comprehensive Cancer Center
  • Baltimore Maryland 21231 United States
  • Walter Reed National Military Medical Center
  • Bethesda Maryland 20889 United States
  • University of Massachusetts Medical School
  • Worcester Massachusetts 01605 United States
  • New Mexico Oncology Hematology Consultants (NMOHC)
  • Albuquerque New Mexico 87109 United States
  • University of New Mexico Cancer Center
  • Albuquerque New Mexico 87131 United States
  • Advanced Radiation Centers of New York
  • Bronx New York 10461 United States
  • Advanced Radiation Centers of New York
  • Hartsdale New York 10530 United States
  • Advanced Radiation Centers of New York
  • Hauppauge New York 11749 United States
  • Advanced Radiation Centers of New York (Integrated Medical Professionals)
  • North Hills New York 11042 United States
  • Advanced Radiation Centers of New York
  • Plainview New York 11803 United States
  • Associated Medical Professionals of NY, PLLC
  • Syracuse New York 13210 United States
  • Advanced Radiation Centers of New York
  • West Nyack New York 10994 United States
  • Southwest Urology, Clinical Research Solutions
  • Middleburg Heights Ohio 44130 United States
  • Oregon Urology Institute
  • Springfield Oregon 97477 United States
  • Lancaster Urology
  • Lancaster Pennsylvania 17604 United States
  • Fox Chase Cancer Center
  • Philadelphia Pennsylvania 19111-2497 United States
  • Allegheny General Hospital, Allegheny Health Network
  • Pittsburgh Pennsylvania 15212 United States
  • Triangle Urological Group, Allegheny Health Network
  • Pittsburgh Pennsylvania 15212 United States
  • Urology Clinics of North Texas
  • Dallas Texas 75231 United States
  • Dr. Irving Fishman's Office
  • Houston Texas 77030 United States
  • Houston Willowbrook Radiation Oncology
  • Houston Texas 77070 United States
  • Dr. Ned Stein's Office
  • Houston Texas 77074 United States
  • Millennium Radiation Center - The Woodlands
  • The Woodlands Texas 77380 United States
  • Texas Urology Specialists
  • Tomball Texas 77375 United States

View trial on ClinicalTrials.gov


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A Randomized Study of Enzalutamide in Patients With Localized Prostate Cancer Undergoing Active Surveillance (ENACT)


Condition: Prostate Cancer

Intervention:

  • Drug: Enzalutamide
  • Other: Active Surveillance

Purpose: The primary purpose of this study is to compare the time to prostate cancer progression (pathological or therapeutic progression) between patients treated with enzalutamide versus patients undergoing active surveillance.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02799745

Sponsor: Astellas Pharma Global Development, Inc.

Primary Outcome Measures:

  • Measure: Time to prostate cancer progression
  • Time Frame: From study screening to end of study (up to three years after screening)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Safety assessed by adverse events (AE)
  • Time Frame: Up to end of study (up to two years)
  • Safety Issue:
  • Measure: Incidence of negative biopsies for cancer at 1 year
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Incidence of negative biopsies for cancer at 2 years
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Percent of cancer positive cores at 1 year
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Percent of cancer positive cores at 2 years
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Time to PSA (Prostate Specific Antigen) progression
  • Time Frame: From study screening to end of study (up to three years after screening)
  • Safety Issue:
  • Measure: Incidence of secondary rise in serum PSA at 1 year
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Incidence of secondary rise in serum PSA at 2 years
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Brief Fatigue Index (BFI)
  • Time Frame: Baseline up to 24 months, approximately every 3-6 months
  • Safety Issue:
  • Measure: Medical Outcomes study 12-item short form (SF-12) assessments
  • Time Frame: Baseline up to 24 months, approximately every 6 months
  • Safety Issue:
  • Measure: Expanded Prostate Cancer Index Composite (EPIC) questionnaire (urinary, sexual and hormonal domains)
  • Time Frame: Baseline up to 24 months, approximately every 6 months
  • Safety Issue:
  • Measure: Memorial Anxiety Scale for Prostate Cancer (MAX-PC) questionnaire
  • Time Frame: Baseline up to 24 months, approximately every 6 months
  • Safety Issue:
  • Measure: Safety assessed by vital sign measurement: pulse
  • Time Frame: Up to end of study (up to two years)
  • Safety Issue:
  • Measure: Safety assessed by vital sign measurement: blood pressure
  • Time Frame: Up to end of study (up to two years)
  • Safety Issue:
  • Measure: Safety assessed by vital sign measurement: heart rate
  • Time Frame: Up to end of study (up to two years)
  • Safety Issue:
  • Measure: Safety assessed by vital sign measurement: body temperature
  • Time Frame: Up to end of study (up to two years)
  • Safety Issue:
  • Measure: Number of participants with abnormal laboratory values and/or adverse events related to treatment
  • Time Frame: Up to end of study (up to two years)
  • Safety Issue:

Estimated Enrollment: 222

Study Start Date: May 24, 2016

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically proven adenocarcinoma of the prostate diagnosed (with ≥10 core biopsy) within 6 months of screening. The biopsy that was used for this diagnosis must be submitted for central pathology review.
  • Prostate cancer categorized (as determined by central pathology review) as low risk is defined as T1c-T2a, PSA<10, N0, M0 (or presumed N0, M0 if CT/bone scan not done due to low risk of metastases), GS ≤ 6, ECOG status ≤2 and estimated life expectancy >5 years OR intermediate risk is defined as T2b-T2c, PSA<20, N0, M0 (or presumed N0, M0 if CT/bone scan not done), GS ≤7 (3+4 pattern only), ECOG status ≤ 2 and estimated life expectancy > 5 years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density <0.15 ng/mL/g) is not included.
  • Ability to swallow study drugs and to comply with study requirements throughout the study
  • Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
  • Throughout study, male subject and a female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom barrier method of contraception) starting at screening and continuing throughout the study period and for three months after the final study drug administration. Two acceptable methods of birth control thus include the following: 1. Condom (barrier method of contraception) AND 2. One of the following is required: i. Established use of oral, injected or implanted hormonal methods of contraception by the female partner; ii. Placement of an intrauterine device or intrauterine system by the female partner; iii. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam / gel / film / cream / suppository by the female partner; iv. Tubal ligation in the female partner.
  • Must not donate sperm starting at screening throughout the study period and for 90 days after the final study drug administration.

Exclusion Criteria:

  • Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
  • Very low risk category (T1c, GS ≤6, PSA <10 ng/mL, fewer than 3 prostate biopsy cores positive, ≤50% cancer in any core, PSA density <0.15 ng/mL/g)
  • Prior transurethral resection of the prostate or prior transurethral microwave thermotherapy of the prostate
  • Use of oral glucocorticoids within 1 month of screening
  • Use of 5 alpha reductase inhibitor within 1 month of screening or total use, within the last two years prior to screening, of >3 months
  • Presence of metastatic disease
  • History of seizure or any condition that may predispose to seizures at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months of screening
  • Absolute neutrophil count < 1,500/μL, platelet count < 100,000/μL, or hemoglobin < 6.2 mmol/L (10 g/dL) at screening
  • Total bilirubin >1.5 times the upper limit of normal (ULN) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 X ULN at screening
  • Creatinine > 177 μmol/L (> 2 mg/dL) at screening
  • Albumin < 30 g/L (3.0 g/dL) at screening
  • Major surgery within 4 weeks prior to Randomization Visit
  • Clinically significant cardiovascular disease including: 1. Myocardial infarction or uncontrolled angina within 6 months 2. Congestive heart failure New York Heart Association (NYHA) class 3 or 4 3. History of clinically significant ventricular arrhythmias 4. History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place 5. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening 6. Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram (ECG) and on physical examination 7. Uncontrolled hypertension as indicated by at least 2 consecutive measurements of a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the Screening Visit
  • Known hypersensitivity to enzalutamide or any of its components.
  • Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to screening

Contact:

  • Astellas Pharma Global Development
  • 800-888-7704 Ext. 5473

Locations:

  • Site US10034
  • Birmingham Alabama 35223 United States
  • Site US10024
  • Homewood Alabama 35209 United States
  • Site US10005
  • Anchorage Alaska 99503 United States
  • Site US10007
  • Tucson Arizona 85704 United States
  • Site US10055
  • Tucson Arizona 85741 United States
  • Site US10004
  • Los Angeles California 90048 United States
  • Site US10026
  • Sacramento California 95670 United States
  • Site US10002
  • San Diego California 92120 United States
  • Site US10010
  • San Diego California 92123 United States
  • Site US10064
  • San Jose California 95124 United States
  • Site US10051
  • Aurora Colorado 80045 United States
  • Site US10029
  • Denver Colorado 80211 United States
  • Site US10054
  • Denver Colorado 80220 United States
  • Site US10072
  • Bradenton Florida 34205 United States
  • Site US10057
  • Lakeland Florida 33805 United States
  • Site US10066
  • Atlanta Georgia 30312 United States
  • Site US10038
  • Chicago Illinois 60611 United States
  • Site US10074
  • Chicago Illinois 60612 United States
  • Site US10070
  • Chicago Illinois 60643 United States
  • Site US10018
  • Glenview Illinois 60026 United States
  • Site US10071
  • Lake Barrington Illinois 60010 United States
  • Site US10040
  • Melrose Park Illinois 60160 United States
  • Site US10046
  • Carmel Indiana 46033 United States
  • Site US10009
  • Jeffersonville Indiana 47130 United States
  • Site US10037
  • New Orleans Louisiana 70112 United States
  • Site US10006
  • Shreveport Louisiana 71106 United States
  • Site US10025
  • Hanover Maryland 21076 United States
  • Site US10001
  • Towson Maryland 21204 United States
  • Site US10032
  • Boston Massachusetts 02111 United States
  • Site US10008
  • Troy Michigan 48084 United States
  • Site US10069
  • Lincoln Nebraska 68516 United States
  • Site US10044
  • Omaha Nebraska 68114 United States
  • Site US10067
  • Omaha Nebraska 68130 United States
  • Site US10039
  • Englewood New Jersey 07631 United States
  • Site US10049
  • Morristown New Jersey 07962 United States
  • Site US10043
  • Voorhees New Jersey 08043 United States
  • Site US10068
  • Brooklyn New York 11215 United States
  • Site US10050
  • Cheektowaga New York 14225 United States
  • Site US10030
  • Garden City New York 11530 United States
  • Site US10028
  • Poughkeepsie New York 12601 United States
  • Site US10021
  • Syracuse New York 13210 United States
  • Site US10022
  • Syracuse New York 13210 United States
  • Site US10047
  • Gastonia North Carolina 28053 United States
  • Site US10020
  • Winston-Salem North Carolina 27157 United States
  • Site US10045
  • Cleveland Ohio 44195 United States
  • Site US10015
  • Middleburg Heights Ohio 44130 United States
  • Site US10053
  • Oklahoma City Oklahoma 73104 United States
  • Site US10063
  • Bala-Cynwyd Pennsylvania 19004 United States
  • Site US10052
  • Lancaster Pennsylvania 17604 United States
  • Site US10014
  • Warwick Rhode Island 02886 United States
  • Site US10019
  • Myrtle Beach South Carolina 29572 United States
  • Site US10011
  • Nashville Tennessee 37209 United States
  • Site US10056
  • Dallas Texas 75231 United States
  • Site US10036
  • Houston Texas 77027 United States
  • Site US10035
  • San Antonio Texas 78229 United States
  • Site US10058
  • Richmond Virginia 23235 United States
  • Site US10041
  • Burien Washington 98166 United States
  • Site US10023
  • Seattle Washington 98101 United States
  • Site US10017
  • Milwaukee Wisconsin 53226 United States
  • Site CA15005
  • Abbotsford British Columbia V2S 3N6 Canada
  • Site CA15004
  • Halifax Nova Scotia B3H 2Y9 Canada
  • Site CA15001
  • Toronto Ontario M4N3M5 Canada
  • Site CA15003
  • Toronto Ontario M5G2M9 Canada

View trial on ClinicalTrials.gov


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Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study


Condition: Prostate Cancer

Intervention:

  • Device: MRI-guided Transurethral Ultrasound Ablation

Purpose: A prospective, multi-center, single-arm study, planned in 110 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02766543

Sponsor: Profound Medical Inc.

Primary Outcome Measures:

  • Measure: Safety Endpoint - Incidence of treatment-emergent adverse events
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Efficacy Endpoint - Proportion of patients achieving a PSA nadir ≤ 25% of the pre-treatment baseline value.
  • Time Frame: 1 year
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Erectile Dysfunction Endpoint
  • Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
  • Safety Issue:
  • Measure: Erection Firmness Endpoint
  • Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
  • Safety Issue:
  • Measure: Urinary Incontinence Endpoint
  • Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
  • Safety Issue:
  • Measure: PSA Nadir Endpoint
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: PSA Stability Endpoint
  • Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
  • Safety Issue:
  • Measure: Prostate Volume Endpoint
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: Prostate Biopsy Endpoint
  • Time Frame: 1 year
  • Safety Issue:
  • Measure: IPSS Endpoint
  • Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
  • Safety Issue:
  • Measure: IIEF Endpoint
  • Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
  • Safety Issue:
  • Measure: EPIC Endpoint
  • Time Frame: At each visit post treatment throughout the total study follow-up - (1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years).
  • Safety Issue:
  • Measure: Targeting Accuracy Endpoint
  • Time Frame: During treatment
  • Safety Issue:
  • Measure: CE-MRI Endpoint
  • Time Frame: Immediately after treatment
  • Safety Issue:
  • Measure: mpMRI Endpoint
  • Time Frame: 1 year
  • Safety Issue:

Estimated Enrollment: 110

Study Start Date: September 21, 2016

Phase: Phase 2

Eligibility:

  • Age: minimum 45 Years maximum 80 Years
  • Gender: Male

Inclusion Criteria:

  1. Male, age 45 to 80 years
  2. Biopsy-confirmed adenocarcinoma of the prostate. Biopsy (minimum 10 cores) obtained ≥ 6 weeks and ≤ 6 months before treatment, or at the discretion of PI.
  3. Clinical stage ≤ T2b
  4. Gleason score ≤ 3 + 4
  5. PSA ≤ 15 ng/ml
  6. Eligible for MRI [Form GCP-10131]
  7. Eligible for general anesthesia (ASA category ≤ 3)
  8. Prostate volume ≤ 90 cc, on Baseline MRI
  9. Prostate size ≤ 5.0 cm in sagittal length, and ≤ 6.0 cm in axial diameter, on Baseline MRI
  10. Life expectancy ≥ 10 years Exclusion Criteria:
  11. Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
  12. Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
  13. Prior definitive treatment of prostate cancer
  14. Prior transurethral resection of the prostate (TURP)
  15. Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
  16. Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound
  17. Cysts > 1 cm in largest diameter, on Baseline MRI
  18. Bleeding disorder (INR > ULN and PTT > ULN)
  19. Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not

Exclusion Criteria:

  1. Evidence (including Baseline MRI and bone scan) of extracapsular extension, sphincter involvement, seminal vesicle invasion, lymph node invasion or metastases
  2. Suspected tumour on Baseline MRI within 3 mm of the prostatic urethra, or in the prostate apex within 3 mm from the sphincter plane
  3. Prior definitive treatment of prostate cancer
  4. Prior transurethral resection of the prostate (TURP)
  5. Use of 5-alpha reductase inhibitors (5-ARIs) or hormone therapy within 3 months prior to the baseline visit. Baseline PSA must be established after a minimum of 3 months following 5-ARIs discontinuation. Additionally, use of 5-ARIs is not permitted following treatment during the study follow-up period.
  6. Prostate calcifications > 1 cm in largest diameter, on Baseline Ultrasound
  7. Cysts > 1 cm in largest diameter, on Baseline MRI
  8. Bleeding disorder (INR > ULN and PTT > ULN)
  9. Abnormal coagulation and current anticoagulant therapy. Patients whose anticoagulation therapy can be temporarily reversed within 7 days prior to treatment are eligible. Platelet inhibitors (ie: ASA) and heparin are not exclusion criteria.
  10. Acute unresolved Urinary Tract Infection (UTI)
  11. Interest in future fertility
  12. History of any other malignancy other than skin cancer, or low grade bladder cancer which has been completely resected, within the previous 2 years. Patients that have had curative treatment of a previous malignancy and no recurrence of that malignancy within the past 2 years will be allowed.
  13. Patients with peripheral arterial disease with intermittent claudication or Leriches Syndrome
  14. Patients with diabetes who have evidence of complications from their diabetes, such as end organ sequelae of diabetes or Hemoglobin A1c > 7%.
  15. History of any major rectal or pelvic surgery or radiotherapy
  16. History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)
  17. Documented clinical prostatitis requiring therapy within 6 months prior to Treatment
  18. History of urethral and bladder outlet disorders, including urethral stricture disease, urethral diverticulae, bladder neck contracture, urethral fistulae, urethral stenting, urethral sling, urethroplasty or chronic indwelling urethral catheter
  19. Patients with artificial urinary sphincter or any penile implant
  20. Severe neurogenic bladder
  21. Untreated bladder stones
  22. History of acute urinary retention within the last 12 months
  23. Active untreated gross hematuria for any cause
  24. Post Void Residual (PVR) bladder volume > 250 mL
  25. Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder, sometimes referred to as "ball valve" median lobe, determined on Baseline MRI
  26. Any prostate related investigational therapy within 6 months of Visit 1
  27. History of Parkinson's disease or multiple sclerosis
  28. History of drug abuse
  29. Known infectious disease including HIV positivity or AIDS-related illness, HBV and HCV
  30. Current unilateral or bilateral hydronephrosis
  31. Allergy or contraindications to administration of the GI anti-spasmodic drug:
  32. Patients in the USA: Glucagon
  33. Patients in Canada and Europe: Buscopan (Hyoscine)
  34. Contraindications to administration of gadolinium-based MRI contrast agent (e.g. Magnevist), such as chronic, severe kidney disease, acute kidney injury, history of Sickle Cell Disease, history of anemia, or intolerance/allergy to the contrast agent
  35. Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results

Contact:

  • Goldy Singh
  • 647.476.1350 Ext. 403

Locations:

  • University of California Los Angeles
  • Los Angeles California 90095 United States
  • University of Chicago
  • Chicago Illinois 60637 United States
  • Indiana University
  • Indianapolis Indiana 46202 United States
  • Johns Hopkins Medicine
  • Baltimore Maryland 21231 United States
  • William Beaumont Hospital
  • Royal Oak Michigan 48073 United States
  • Vanderbilt University Medical Center
  • Nashville Tennessee 37232 United States
  • University of Texas Southwestern Medical Center
  • Dallas Texas 75390-9105 United States
  • London Health Sciences Centre
  • London Ontario N6C 2R5 Canada
  • Sunnybrook Health Sciences Centre
  • Toronto Ontario M4N 3M5 Canada
  • University Hospital of Cologne
  • Cologne 50937 Germany
  • Universitätsklinikum Heidelberg (University of Heidelberg, Dept of Urology)
  • Heidelberg 69120 Germany
  • Radboud University Medical Center
  • Nijmegen 6500 Netherlands
  • Clinica Universidad de Navarra
  • Pamplona Navarra 31008 Spain
  • ResoFus Alomar (Hospital Universitari De Bellvitge)
  • Barcelona 08029 Spain

View trial on ClinicalTrials.gov


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Cognitive Effects of Androgen Receptor (AR) Directed Therapies for Advanced Prostate Cancer


Condition: Castration-Resistant Prostatic Cancer, Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer, Hormone-Refractory Prostate Cancer

Intervention:

  • Biological: GnRH agonist/antagonist
  • Drug: Prednisone
  • Drug: Abiraterone Acetate
  • Drug: Enzalutamide

Purpose: This clinical trial studies cognitive function in men with prostate cancer treated with androgen receptor directed therapies such as abiraterone acetate and enzalutamide. The investigators use MRI imaging (non-invasive, non-contrast) to see whether there are changes in brain structure or activity related to treatment that may be related to changes in cognitive function. The investigators are also looking for genetic variations that might make patients more or less sensitive to cognitive changes during treatment for prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03016741

Sponsor: Vanderbilt-Ingram Cancer Center

Primary Outcome Measures:

  • Measure: Cognitive function defined by overall Cogstate score and Cogstate module scores for each domain
  • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Quality of life assessed using European Organization for Research and Treatment of Cancer quality of life questionnaire-C30 (EORTC QLQ C-30)
  • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
  • Safety Issue:
  • Measure: Fatigue assessed using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT- Fatigue)
  • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
  • Safety Issue:
  • Measure: Subjective measure of cognitive function by FACT-Cog
  • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
  • Safety Issue:
  • Measure: Depression by Patient Health Questionnaire (PHQ-9)
  • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
  • Safety Issue:
  • Measure: Instrumental activities of daily living by Texas Functional Living Scale
  • Time Frame: Measured at baseline, 3 months, 6 months, and 12 months
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: March 31, 2017

Phase: Phase 4

Eligibility:

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

Inclusion Criteria:

  • Have pathologic diagnosis of prostate cancer and have received treatment with GnRH agonist or antagonist therapy for at least 3 months prior to enrollment
  • Willing and able to complete survey questionnaires in English with or without assistance through the duration of the study
  • Life expectancy >= 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Ability to understand and the willingness to sign a written informed consent document written in English that is approved by an institutional review board
  • TREATMENT ARM PATIENTS
  • Have castration-resistant metastatic disease (mCRPC) defined by the following:
  • Castrate serum testosterone level =< 50 ng/dL (1.7 nmol/L)
  • Bilateral orchiectomy or maintenance on androgen ablation therapy with GnRH agonist or antagonist throughout the study (including the follow-up period)
  • Serum prostate specific antigen (PSA) progression, defined as two consecutive increases in PSA over a previous reference value within 6 months prior to enrollment, with each progression measurement at least 1 week apart
  • Willing and medically able to receive treatment with first-line AR directed therapy with abiraterone acetate or enzalutamide as determined and prescribed by the primary physician
  • Patients may have received the following prior AR directed therapy >= 24 months prior to enrollment: bicalutamide, ketoconazole; prior to enrollment, patients may have received treatment with abiraterone acetate or enzalutamide for no more than 7 days before completing baseline studies
  • Patients may have received chemotherapy for hormone-sensitive metastatic prostate cancer only, but it must not have lasted for more than 6 months; at least 12 months must have elapsed since completion of chemotherapy
  • Patients may have received prior radiation therapy or surgery; however, at least 60 days must have elapsed since completion of radiation therapy or surgery and patient must have only grade 2 or less adverse effects at the time of registration
  • Patients must be able to take oral medication
  • CONTROL PATIENTS
  • Control patients must be expected to stay on GnRH agonist or antagonist therapy for high-risk localized, biochemical recurrent or hormone-sensitive metastatic prostate cancer for the entire 12 months of the study; examples of eligible patients include long-term androgen deprivation therapy (ADT) use after definitive external beam radiation for high-risk localized prostate cancer, long-term ADT use after prostatectomy for lymph node positive disease, long-term ADT use for biochemical recurrence or elevated PSA post-prostatectomy, or long-term ADT use for hormone sensitive metastatic prostate cancer; control patients should not expect to receive additional treatments for their prostate cancer during the 12 months of the study, including but not limited to additional salvage or adjuvant radiation, surgery, chemotherapy, or other intervention; if these interventions are expected, enrollment should be delayed until after the intervention; unexpected changes in treatment, including the use of medications for mCRPC, are completely acceptable and at the discretion of the treating physician; questions regarding the eligibility of control patients should be directed to the principal investigator (PI)

Exclusion Criteria:

  • Prior treatment with enzalutamide or abiraterone acetate for > 7 days prior to enrollment and completion of baseline tests
  • Receipt of chemotherapy for prostate or other cancer within the past 12 months with residual cognitive deficits, or receipt of chemotherapy for mCRPC; patients/physicians planning treatment with chemotherapy during the 12 month period of the investigation are also ineligible
  • History of cognitive impairment or dysfunction, including a history of dementia, Alzheimer's disease, stroke with residual cognitive deficits, cognitive dysfunction related to alcohol or substance abuse, or cognitive dysfunction related to prior treatment for any cancer
  • Patients with a seizure history, history of recurrent falls, or known brain metastases are excluded from this clinical trial because of their poor prognosis and because of their heightened risk of seizure or progressive cognitive and/or neurologic dysfunction that would confound the evaluation
  • Uncontrolled intercurrent illness including, but not limited to, uncontrolled diabetes, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations/substance abuse that would limit compliance with study requirements
  • Patients with a "currently active" second malignancy other than non-melanoma skin cancers are not eligible; patients are not considered to have a "currently active" malignancy if they have completed all therapy and are now considered without evidence of disease for 1 year; patients with cognitive dysfunction related to treatment of another malignancy, including a history of "chemo-brain", are ineligible
  • Patients taking psychotropic medications or illicit drugs that may alter cognition, concentration, or behavior; appropriate treatment by a licensed provider with medications for depression or anxiety, including but not limited to selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and standard dose benzodiazepines at a stable dose, is permitted
  • Control patients cannot have a diagnosis of mCRPC

Contact:

  • VICC Clinical Trials Information Program
  • 800-811-8480

Location:

  • Vanderbilt-Ingram Cancer Center
  • Nashville Tennessee 37232 United States

View trial on ClinicalTrials.gov


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A Phase 1/2 Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Seviteronel in Subjects With Castration-Resistant Prostate Cancer


Condition: Castration-resistant Prostate Cancer, CRPC

Intervention:

  • Drug: Seviteronel: given orally once daily in 28 day cycles

Purpose: The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics and activity of Seviteronel, a lyase-selective inhibitor of CYP17, in patients with castration-resistant prostate cancer (CRPC).

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02012920

Sponsor: Innocrin Pharmaceutical

Primary Outcome Measures:

  • Measure: Proportion of subjects who have ≥50% PSA decline at any time on study from the start of treatment with seviteronel.
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Median time to radiographic disease progression evaluated by computerized tomography (CT scan) or magnetic resonance imaging (MRI) and radionuclide bone scans by RECIST 1.1
  • Time Frame: 10 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Radiographic response rate by RECIST 1.1 & PCWG3. Safety of seviteronel with or without concurrent glucocorticoid administration
  • Time Frame: 10 months
  • Safety Issue:

Estimated Enrollment: 200

Study Start Date: December 2011

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1.18 years of age or older 2. Able to provide written informed consent or have their legal representatives provide written informed consent 3. Documented histological or cytological evidence of adenocarcinoma of the prostate. Subjects whose pathology reports are no longer available may be enrolled if, in the opinion of the investigator, the subject has a clinical course consistent with prostatic adenocarcinoma 4. ECOG Performance Status of 0 or 1 5. Undergone orchiectomy, or have ongoing LHRH analogue therapy prior to C1D1. Subjects on LHRH analogues should remain on these agents for the duration of the study 6. Castrate levels of testosterone less than or equal to 50 ng/dl (or 1.7 nmol/L) and have progressive disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values greater than or equal to 1 week between each assessment. The PSA value at the Screening visit must be greater than or equal 2ng/mL with or without: Soft tissue disease progression defined by RECIST 1.1 at Screening or less than or equal to 28 days of C1D1. Measurable disease is not required for entry. Lymph nodes greater than or equal to 1.5cm (short axis) are considered measurable disease bone disease progression defined by greater than or equal 2 new lesions on bone scan at Screening, or less than or equal 28 days of C1D1 7. Have received abiraterone and/or enzalutamide. Subject must have received either abiraterone or enzalutamide for greater than or equal to 12 weeks. Other second generation CYP17 inhibitors/androgen receptor antagonists including but not limited to TAK-700 (orteronel), TOK-001 (galeterone) may have been taken in place of abiraterone and ARN-509 (apalutamide) may have been taken in place of enzalutamide. 8. Adequate hematopoietic function as evidenced by:
  • WBC greater than or equal to 3,000/μl
  • ANC greater than or equal to 1,500/μl
  • Platelet count greater than or equal to 100,000/μl
  • HGB greater than or equal to 10 g/dl and not transfusion dependent 9. Adequate liver function, including all the following:
  • Total serum bilirubin less than or equal to 2.0 x ULN unless the subject has documented Gilbert syndrome;
  • Aspartate and alanine aminotransferase (AST & ALT) less than or equal to 3.0 x ULN or less than or equal to 5.0 x ULN if subject has liver metastasis;
  • Alkaline phosphatase less than or equal to 3.0 x ULN or less than or equal to 5 x ULN in case of bone metastasis and/or hepatic metastasis 10. Subjects must have adequate renal function as evidenced by a serum creatinine of less than or equal to 2.0 mg/dl 11. Potassium (K+) greater than or equal to 3.5 mEq/l 12. Subject and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period and for 3 months after final study drug administration.
  • Two acceptable forms of birth control include: 1. Condom (barrier method of contraception), and 2. One of the following: 1. Oral, injected or implanted hormonal contraception 2. Placement of an intrauterine device (IUD) or intrauterine system (ISU) 3. Additional barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. 4. Vasectomy or surgical castration greater than or equal to 6 months prior to Screening. 13. Able to swallow study medication 14. Able to comply with study requirements

Exclusion Criteria:

  1. Each subject eligible to participate in this study must not have any of the following:
  2. Received sipuleucel-T (Provenge ®) treatment within 28 days of C1D1
  3. Received 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or dutasteride (AVODART®) within 28 days of C1D1
  4. Received any investigational agent less than or equal to 28 days of C1D1
  5. Received palliative radiotherapy less than or equal to 2 weeks of C1D1
  6. Symptomatic CNS metastases
  7. History of another invasive malignancy less than or equal to 3 years of C1D1
  8. A QTcF interval of greater than 470 msec; if the Screening ECG QTcF interval is greater than 470 msec, it may be repeated, and if repeat less than or equal to 470 msec, the subject may be enrolled
  9. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes, second degree or third degree atrioventricular heart block without a permanent pacemaker in place)
  10. Started a bone modifying agent (e.g. bisphosphonates, denosumab) less than or equal to 28 days of C1D1 (note: ongoing bone modifying agents administered less than 28 days are allowed)
  11. Any medical condition that could preclude subject participation in the study, pose an undue medical hazard, or which could interfere with study results
  12. Class III or IV Congestive Heart Failure (CHF) as defined by the New York Heart Association (NYHA) functional classification system within the previous 6 months
  13. A history of loss of consciousness or transient ischemic attack less than or equal to 12 months of C1D1
  14. Known active HIV, Hepatitis B, or Hepatitis C infections
  15. Known or suspected hypersensitivity to seviteronel, or any components of the formulation
  16. Any other condition which in the opinion of the investigator would preclude participation in the study

Contact:

  • Lisa Franklin
  • 919-695-9493

Locations:

  • Urology Centers of Alabama
  • Homewood Alabama 35209 United States
  • H. Lee Moffitt Cancer and Research Institute
  • Tampa Florida 33612 United States
  • First Urology, PSC
  • Jeffersonville Indiana 47130 United States
  • Wichita Urology
  • Wichita Kansas 67226 United States
  • Urology Cancer Center
  • Omaha Nebraska 68130 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 86169 United States
  • North Shore Hematology Oncology Associates
  • East Setauket New York 11733 United States
  • NY Cancer and Blood Specialists
  • The Bronx New York 10469 United States
  • Duke Cancer Institute at Cary: Medical Oncology
  • Cary North Carolina 27518 United States
  • Duke University Medical Center
  • Durham North Carolina 27710 United States
  • Gabrail Cancer Center Research
  • Canton Ohio 44718 United States
  • Urologic Consultants of Southeastern Pennsylvania
  • Bala-Cynwyd Pennsylvania 19004 United States
  • Charleston Hematology Oncology Associates
  • Charleston South Carolina 29414 United States
  • Carolina Urologic Research Center
  • Myrtle Beach South Carolina 29572 United States
  • Urology Clinics of North Texas
  • Dallas Texas 75231 United States
  • University of Texas MD Anderson Cancer Center
  • Houston Texas 77030 United States
  • Virginia Oncology Associates
  • Norfolk Virginia 23502 United States
  • University of Wisconsin Carbone Cancer Center
  • Madison Wisconsin 53792 United States
  • Alexandria Hospital, Department of Oncology
  • Athens 11528 Greece
  • Kantonsspital St Gallen, Onkologie/ Hamatologie
  • St Gallen CH-9007 Switzerland
  • The Royal Marsden Hospital - Institute of Cancer Research
  • Sutton Surrey United Kingdom

View trial on ClinicalTrials.gov


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Prospective Study of Apalutamide and Abiraterone Acetate iN ChemoTHerapy-Naïve mEn With mCRPC Stratified by Race


Condition: Prostate Cancer

Intervention:

  • Drug: ARN-509
  • Drug: Abiraterone Acetate
  • Drug: Prednisone

Purpose: The primary goal is to prospectively estimate the median PFS of African American and Caucasian men with mCRPC taking apalutamide, abiraterone acetate, and prednisone. Secondary objectives include: PSA kinetics: to determine the duration of PSA response, time to nadir, and percent of men who achieve a PSA < 0.1; Radiographic assessments: to estimate the rate of objective response and incidence of bone flares; Safety (NCI CTC v4.0) and tolerability, particularly incidence and grade of hypertension in the two populations. This is a non-comparative pilot open-label, parallel arm, multicenter study of apalutamide and abiraterone acetate in African American and Caucasian men with mCRPC. It is anticipated that 3 additional sites will be needed to accrue 100 subjects (50 African American and 50 Caucasian) over a 24 month accrual period. The study agents will be administerd at the following doses: apalutamide 240mg orally once daily, abiraterone acetate 1000mg orally once daily, and prednisone 5 mg BID in 4-week cycles throughout the treatment period. Fifty (50) patients will be enrolled in each group (AA and Caucasians). The proportion of patients who experience PSA decline of 30%, 50% and 90% will be estimated with exact 95% confidence intervals based on the binomial distribution will be computed. In addition, post therapy changes in PSA will be explored as a continuous outcome. The Kaplan-Meier product limit method will be used to estimate the rPFS, biochemical PFS and overall survival distributions.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03098836

Sponsor: Daniel George, MD

Primary Outcome Measures:

  • Measure: Median radiographic progression free survival (PFS)
  • Time Frame: every 12 weeks, up to 2 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Change in PSA response
  • Time Frame: every 4 weeks, up to 2 years
  • Safety Issue:
  • Measure: Time to PSA nadir
  • Time Frame: every 4 weeks, up to 2 years
  • Safety Issue:
  • Measure: Percent of men who achieve a PSA < 0.1
  • Time Frame: every 4 weeks, up to 2 years
  • Safety Issue:
  • Measure: Change in radiologic response rates
  • Time Frame: every 12 weeks, up to 2 years
  • Safety Issue:
  • Measure: Number of adverse events
  • Time Frame: up to 2 years
  • Safety Issue:

Estimated Enrollment: 100

Study Start Date: July 10, 2017

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Male, age ≥ 18 years 2. Karnofsky performance status ≥ 70 (Appendix 1) 3. Life expectancy of ≥ 12 months as determined by treating investigator 4. Written Authorization for Use and Release of Health and Research Study Information (HIPAA authorization per institutional requirements) 5. Willing/able to adhere to the prohibitions and restrictions specified in this protocol 6. Willing to take abiraterone acetate on an empty stomach, and should be able to swallow tablets whole, without crushing/chewing tablets. Must have the ability to swallow, retain, and absorb oral medication. 7. Medications known to lower the seizure threshold (see list under prohibited meds, appendix 2) must be discontinued or substituted at least 4 weeks prior to study entry 8. 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. Abstinence is an acceptable method of birth control. 9. Adequate bone marrow function as shown by: ANC ≥ 1.0 x 109/L, Platelets ≥ 100 x 109/L, Hb≥9 g/dL, (independent of transfusion and/or growth factors within 3 months prior to randomization) 10. Serum potassium ≥ 3.5 mEq/L 11. Serum albumin of ≥ 3.0 g/dl 12. AST/SGOT and ALT/SGPT <2.5 x Institutional Upper Limit of Normal (ULN) 13. Serum total bilirubin ≤ 1.5 x Institutional ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible) 14. GFR ≥45 mL/min 15. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Histologic variants of prostate cancer comprising of >50% of the tumor including neuroendocrine features and small cell carcinoma of the prostate are excluded. 16. Radiographic evidence of metastatic disease based on RECIST 1.1 Criteria 17. Ongoing ADT using an LHRH agonist (e.g. leuprolide, goserelin) or antagonist (e.g. degarelix) must continue on therapy unless prior bilateral orchiectomy has been performed. 18. Screening serum testosterone must be <50 ng/dL. 19. PSA ≥ 2.0 ng/mL 20. Evidence of castration resistant disease on ADT as evidenced by one of the following:
  • Absolute rise in PSA of 2.0 ng/mL or an increase >25% from the nadir, minimum 2 consecutive rising PSA levels with an interval of ≥ 1 week between each PSA level, OR
  • 2 consecutive PSA levels 50% or greater above the PSA nadir achieved on ADT and separated at least 1 week apart, OR
  • CT or MRI based evidence of disease progression (soft tissue, nodal or visceral disease progression) according to PCWG3 criteria or RECIST 1.1 criteria, OR
  • At least 1 new bone scan lesion as compared to the most immediate prior radiologic studies. 21. A minimum of 2 weeks elapsed off of antiandrogen therapy prior to start of study drug (i.e. flutamide, nilutamide, bicalutamide.) 22. A minimum of 2 weeks elapsed off of sipuleucel-T and radiation therapy prior to start of study drug 23. A minimum of 4 weeks from any major surgery prior to start of study drug. 24. Self-reported race of either African American or Caucasian. 25. Ability to understand and the willingness to sign a written informed consent document. If the subject is unable to understand the consent due to comorbidity, such as Alzheimer's disease, consent by a legally authorized representative and assent by the subject will be obtained.

Exclusion Criteria:

  • 1. Prior treatment with abiraterone acetate, enzalutamide, apalutamide (ARN-509), galaterone (TOK-001), orteronel (TAK-700), or similar agent 2. Active infection or other medical condition that would make prednisone/prednisolone (corticosteroid) use contraindicated 3. Active or symptomatic infection including HIV, viral hepatitis or chronic liver disease 4. Any chronic medical condition requiring a higher dose of corticosteroid than 5mg prednisone/prednisolone bid 5. Have known allergies, hypersensitivity, or intolerance to abiraterone acetate, apalutamide or prednisone or their excipients. 6. Pathological finding consistent with small cell carcinoma of the prostate 7. Symptomatic liver or visceral organ metastasis 8. Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of the study agents 9. Known brain metastasis 10. Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC 11. Previously treated with ketoconazole for prostate cancer for greater than 7 days 12. Prior systemic treatment with an azole drug (e.g. fluconazole, itraconazole) within 4 weeks of Cycle 1, Day 1. 13. Uncontrolled hypertension (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg). Patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment 14. Poorly controlled diabetes, FBS ≥200 mg/dL 15. History of pituitary or adrenal dysfunction 16. Symptomatic Atrial Fibrillation, or other symptomatic cardiac arrhythmia 17. Other malignancy, except non-melanoma skin cancer, with a ≥ 30% probability of recurrence within 24 months 18. History of any of the following:
  • Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 6 months of randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
  • 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 first dose of study drug. Venous thrombolic events within 6 months are permitted IF they are not attributed to prostate cancer (in the opinion of the treating physician). 19. Avoid concomitant strong CYP3A4 inducers during abiraterone acetate treatment. 20. Avoid co-administration of abiraterone acetate with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate 21. Baseline moderate or severe hepatic impairment (Child Pugh Class B & C) 22. Use of herbal products that may decrease PSA levels (i.e., saw palmetto) refer to section 8.3.1 23. Administration of an investigational therapeutic within 30 days prior to Cycle 1, Day 1 24. Any condition which, in the opinion of the investigator, would preclude participation in this trial

Contact:

  • Julia Rasmussen, MS, BSN
  • 919-681-1030

Locations:

  • Duke Cancer Center Cary
  • Cary North Carolina 27518 United States
  • Duke University Medical Center
  • Durham North Carolina 27710 United States

View trial on ClinicalTrials.gov


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Phase III Randomized Trial Comparing Short Course Androgen Deprivation Therapy and Ultra-Hypofractionated SBRT Versus SBRT Alone For Intermediate Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Drug: Degarelix
  • Radiation: stereotactic body radiosurgery (SBRT)

Purpose: Stereotactic body radiation therapy (SBRT) is a very precise form of radiation therapy that allows the physician to deliver more radiation dose in a single session. Because of this, the number of radiation sessions can be reduced from the typical 45-48 sessions, as in conventional daily session radiation, to 5 sessions given every other day over a week and a half. Giving the radiation at a higher dose during each treatment may be more effective in killing the prostate cancer cells than the standard way of using external radiation therapy where a small amount of radiation is given over many sessions. Androgen Deprivation Therapy (ADT) or hormonal therapy is one of the methods to treat intermediate risk prostate cancer. This therapy works by reducing the level of testosterone and stopping them from affecting your cancer. The ADT used in this study is known as Degarelix. Degarelix is an approved medication that reduces the body's production of testosterone; this medication is usually given to all men with intermediate risk prostate cancer getting external radiation. This study is a randomized study to find out whether combining stereotactic (also known as precision) radiation to the prostate cancer combined with a short course of Degarelix will result in a greater likelihood of killing the cancer in the prostate compared to stereotactic radiation therapy given alone. It has been shown that the combination of radiation with medications that interfere with testosterone production and its effects makes prostate cancer cells more sensitive to the radiation.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03056638

Sponsor: Memorial Sloan Kettering Cancer Center

Primary Outcome Measures:

  • Measure: number of patients with a positive biopsy
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 200

Study Start Date: March 28, 2017

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Biopsy proven intermediate risk prostate cancer, which includes patients with any one of the following variables:
  • Gleason 7 disease
  • PSA 10-20 ng/ml
  • Clinical T2b-T2c disease Note: Patients who only have radiographic evidence of T3 disease (i.e. extracapsular extension, or seminal vesical invasion radiographically) will not be excluded.
  • Serum testosterone ≥ 240 ng/dL determined within 2 months prior to enrollment
  • At least 4 weeks must have elapsed from major surgery
  • KPS ≥ 80%
  • Prostate size as determined on MRI to be < 90 cc. Prostate size can be determined on CT scan if MRI is not available.
  • 18 years of age or older
  • IPSS ≤ 20
  • Patient must be available for follow-up. After 2 years of follow-up following post-treatment biopsy, telephone-based follow-up will be acceptable
  • Laboratory test findings within 8 weeks of randomization:
  • Adequate hepatic function with serum bilirubin ≤ 1.5 times the upper institutional limits of normal (ULN), ALT and AST ≤ 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin
  • Adequate renal function with serum creatinine ≤ 1.5 x ULN
  • Adequate hematologic function with absolute neutrophil counts ≥ 1,500 cell/mm3 and platelets ≥ 100,000 cells/mm3 and hemoglobin value ≥ 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value ≥ 9 g/dL with blood transfusions are allowed)

Exclusion Criteria:

  • CT or MRI evidence of metastatic disease to the bone.
  • Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT
  • Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior TURP or greenlight PVP which would be allowed)
  • History of another malignancy within the previous 3 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years
  • Patients with Crohn's disease or ulcerative colitis

Contact:

  • Michael Zelefsky, MD
  • 212-639-6802

Locations:

  • Baptist Alliance MCI
  • Miami Florida 33143 United States
  • Memorial Sloan Kettering Basking Ridge
  • Basking Ridge New Jersey 07920 United States
  • Memorial Sloan Kettering Monmouth
  • Middletown New Jersey 07748 United States
  • Memorial Sloan Kettering Commack
  • Commack New York 11725 United States
  • Memorial Sloan Kettering Westchester
  • Harrison New York 10604 United States
  • Memorial Sloan Kettering Cancer Center
  • New York New York 10065 United States
  • Memorial Sloan Kettering Rockville Centre
  • Rockville Centre New York 11570 United States

View trial on ClinicalTrials.gov


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