Prostate Cancer

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Systemic and Tumor-Directed Therapy for Oligometastatic Prostate Cancer


Condition: Newly Diagnosed Oligometastatic Prostate Cancer

Intervention:

  • Procedure: radical prostatectomy
  • Radiation: stereotactic body radiotherapy
  • Drug: Leuprolide
  • Drug: apalutamide
  • Drug: abiraterone

Purpose: This is a trial for patients with newly diagnosed metastatic prostate cancer with 5 or fewer sites of metastases. The trial involves surgery (removal of the prostate), six months of hormone therapy, and stereotactic body radiotherapy to the sites of metastasis.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03298087

Sponsor: VA Office of Research and Development

Primary Outcome Measures:

  • Measure: PSA<0.05ng/mL
  • Time Frame: 6 months after recovery of testosterone
  • Safety Issue:

Estimated Enrollment: 28

Study Start Date: December 1, 2017

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Biopsy confirmed diagnosis of prostate adenocarcinoma (primary small cell carcinoma of the prostate is not allowed, however adenocarcinoma with neuroendocrine differentiation is allowed)
  2. Age 18
  3. Presence of 1-5 visible metastases (by NaF PET-CT or PSMA PET-CT including diagnostic CT of the chest, abdomen, and pelvis)
  4. At least one metastasis must be M1a-b
  5. Visceral metastases are not allowed
  6. Patients may have any number of pelvic nodal metastases (but largest must be <2 cm)
  7. Metastases must be amenable to treatment with SBRT
  8. Biopsy of one metastasis must be attempted, unless unsafe to perform. If biopsy is not diagnostic, or unsafe to perform, then a secondary imaging modality (for example, MRI) must also be consistent with metastatic disease (unless PSMA PET-CT was used as initial staging).
  9. Patient must be fit to undergo radical prostatectomy, SBRT to all visible sites of metastases, ADT,
  10. Total testosterone >200 ng/dL prior to ADT (optimal time to measure total testosterone is between 8 and 9 am)
  11. Adequate performance status (ECOG 0-1)
  12. Clinical laboratory values at screening:
  13. Hemoglobin 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
  14. Platelet count 100,000 x 109/ L independent of transfusion and/or growth factors within 3 months prior to randomization
  15. Serum albumin 3.0 g/dL
  16. GFR 45 mL/min
  17. Serum potassium 3.5 mmol/L
  18. Serum total bilirubin 1.5 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)
  19. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5 ULN
  20. Medications known to lower the seizure threshold (see list under prohibited medications) must be discontinued or substituted at least 4 weeks prior to study entry.

Exclusion Criteria:

  1. Any evidence of spinal cord compression (radiological or clinical)
  2. Prior pelvic malignancy
  3. Prior pelvic radiation
  4. Concurrent malignancy aside from superficial skin cancers or superficial bladder tumors
  5. Inability to undergo prostatectomy, radiotherapy, or ADT
  6. Primary small cell carcinoma of the prostate (prostate adenocarcinoma with neuroendocrine differentiation is allowed)
  7. Inflammatory bowel disease or active collagen vascular disease
  8. History of any of the following:
  9. Seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1year to randomization, brain arteriovenous malformation, Schwannoma, meningioma, or other benign CNS or meningeal disease which may require treatment with surgery or radiation therapy)
  10. Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomization
  11. Current evidence of any of the following:
  12. Uncontrolled hypertension
  13. Gastrointestinal disorder affecting absorption
  14. Active infection (eg, human immunodeficiency virus [HIV] or viral hepatitis)
  15. Any chronic medical condition requiring a higher dose of corticosteroid than 10 mg prednisone/prednisolone once daily
  16. Any condition that in the opinion of the investigator would preclude participation in this study
  17. Concomitant strong CYP3A4 inducers. (If a strong CYP3A4 inducer must be co-administered, abiraterone acetate dose frequency will be adjusted).
  18. Treatment with CYP2D6 substrates that have a narrow therapeutic index. If an alternative treatment cannot be used, a dose reduction of the CYP2D6 substrate may be considered.
  19. Baseline severe hepatic impairment (ChildPugh Class B & C)
  20. Presence of visceral metastases (i.e., stage M1c)

Contact:

  • Nicholas G Nickols, MD PhD
  • (310) 478-3711

Location:

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • West Los Angeles California 90073 United States

View trial on ClinicalTrials.gov


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Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer


Condition: Castration Levels of Testosterone, Metastatic Prostatic Adenocarcinoma, Stage IV Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage IVB Prostate Cancer AJCC v8

Intervention:

  • Drug: Abiraterone
  • Drug: Bicalutamide
  • Drug: Degarelix
  • Drug: Docetaxel
  • Drug: Flutamide
  • Drug: Goserelin Acetate
  • Drug: Histrelin Acetate
  • Drug: Leuprolide Acetate
  • Drug: Nilutamide
  • Procedure: Orchiectomy
  • Drug: Prednisone
  • Other: Quality-of-Life Assessment
  • Radiation: Radiation Therapy
  • Procedure: Radical Prostatectomy
  • Drug: Triptorelin

Purpose: This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03678025

Sponsor: Southwest Oncology Group

Primary Outcome Measures:

  • Measure: Overall survival (OS)
  • Time Frame: From date of randomization to date of death due to any cause, assessed up to 8 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Media OS
  • Time Frame: From date of randomization to date of death due to any cause, assessed up to 8 years
  • Safety Issue:
  • Measure: Rate of symptomatic local progression
  • Time Frame: Up to 8 years
  • Safety Issue:
  • Measure: Progression-free survival (PFS)
  • Time Frame: From date of randomization to date of first documentation of progression, or death due to any cause, assessed up to 8 years
  • Safety Issue:

Estimated Enrollment: 1273

Study Start Date: September 17, 2018

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate. Patients with pure small cell carcinoma* (SCC), sarcomatoid, or squamous cell carcinoma are not eligible. (*morphology must be consistent with SCC; synaptophysin or chromogranin positive by immunohistochemical staining is insufficient to diagnose SCC).
  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have an intact prostate. No prior local therapy for prostate adenocarcinoma is allowed (e.g., brachytherapy, high-intensity focused ultrasound [HIFU], cryotherapy, laser ablative therapies). Any prior therapy for benign conditions, such as obstruction, are acceptable (e.g., transurethral resection of the prostate, greenlight laser ablation, microwave ablation).
  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients must have evidence of metastatic disease on technetium bone scan and computed tomography (CT) or magnetic resonance imaging (MRI) within 42 days prior to starting standard systemic therapy. Metastatic disease that is detected by positron emission tomography (PET) scan only (sodium fluoride [NaF], prostate-specific membrane antigen [PSMA], anti-1-amino-3-18F-fluorocyclobutane-1-carboxylic acid [FACBC], carbon [C]11) but not conventional imaging (technetium [Tc]99 bone scan, CT or MRI) or solitary metastases by conventional imaging, must be confirmed histologically or cytologically.
  • STEP 1 REGISTRATION: DISEASE-RELATED CRITERIA: Patients with known brain metastases are not eligible. Brain imaging studies are not required for eligibility if the patient has no neurologic signs or symptoms suggestive of brain metastasis. If brain imaging studies are performed, they must be negative for disease.
  • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received no more than 28 weeks of standard systemic therapy (SST). SST is defined as current National Comprehensive Cancer Network (NCCN) guidelines for metastatic prostate cancer.
  • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not have progressed while on SST.
  • STEP 1 REGISTRATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients with oligometastatic prostate cancer may receive metastasis directed therapy to up to four sites of disease prior to randomization.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a complete physical examination and medical history within 28 days prior to registration.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA documented prior to initiation of SST and within 28 days prior to registration. Any additional PSAs measured while receiving SST should be recorded.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone lab documented within 28 days prior to randomization. Any additional testosterone labs measured while receiving SST should be recorded as well as pretreatment initiation if available.
  • STEP 1 REGISTRATION: CLINICAL/LABORATORY CRITERIA: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, adequately treated stage 0, I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
  • STEP 1 REGISTRATION: SPECIMEN SUBMISSION CRITERIA: Patients must be offered the opportunity to participate in translational medicine studies and specimen banking for future studies.
  • STEP 1 REGISTRATION: QUALITY OF LIFE CRITERIA: Patients who can complete Patient-Reported Outcome instruments in English, Spanish or French, must participate in the quality of life studies.
  • STEP 1 REGISTRATION: REGULATORY CRITERIA: Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
  • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have no evidence of disease progression during the 28 weeks of SST by PSA measure, bone scan and CT or MRI or symptomatic deterioration (as defined by physician discretion) within 28 days prior to randomization.
  • STEP 2 RANDOMIZATION: DISEASE-RELATED CRITERIA: Patients must have consultation with a urologist and have surgically resectable disease regardless of definitive treatment intent or randomization.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must have received between 22 and 28 weeks of SST as measured from the date of first hormonal therapy or surgical castration. SST is defined by current NCCN guidelines for metastatic prostate cancer.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients must not be planning to receive docetaxel after randomization.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Any toxicities from SST must have resolved to =< grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) prior to randomization.
  • STEP 2 RANDOMIZATION: PRIOR/CONCURRENT THERAPY CRITERIA: Patients may have received elective metastasis directed therapy to oligometastatic sites (=< 4 sites). All treatment must be completed prior to randomization.
  • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a PSA performed within 28 days prior to randomization.
  • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a testosterone < 50 ng/dL within 28 days prior to randomization.
  • STEP 2 RANDOMIZATION: CLINICAL/LABORATORY CRITERIA: Patients must have a Zubrod performance status of 0 ? 1 within 28 days prior to randomization.

Contact:

  • Dana Sparks, MAT
  • 2106148808 Ext. 1004

Location:

  • MD Anderson Cancer Center
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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Cystoprostatectomy Versus Radiotherapy Combined With Androgen Deprivation Therapy for the Treatment of Clinical T4 Prostate Cancer With Bladder Invasion: a Multicentre, Prospective, Open, Randomized Clinical Trial


Condition: Prostate Cancer

Intervention:

  • Procedure: Cystoprostatectomy
  • Radiation: external beam radiotherapy

Purpose: Prostate cancer is the most common male cancer in global, which accounts for 19% of the total and poses great hazards to male health. Unfavorable factors including prostatic specific antigen (PSA) >20 ng/ml, Gleason score >8, and T3/4 are significantly associated with biological recurrence, metastatic progression and poor survival in prostate cancer. In clinical T4(cT4) prostate cancer with bladder invasion patients, symptoms of hematuria, urinary urgency, bladder outlet and ureteral obstruction, and pelvic pain led to a poor quality of life. Radical prostatectomy is crucial for the multimodal treatment of prostate cancer, but limited proof demonstrated enough advantages of the surgery in T4 tumor with bladder invasion. Radical prostatectomy could hardly meet both demands of local tumor control and urinary function. Treatment trends suggest that patients with T4 prostate cancer be treated with radiotherapy combined with androgen deprivation therapy (ADT). However, surgery enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Cystoprostatectomy offers an option of surgical treatment for T4 prostate cancer with bladder invasion,which can well remove the bladder and urethra, decrease the risk of positive surgical margins and avoid urination complications. There is no consensus regarding optimal treatment of T4 prostate cancer and no evidence of oncological outcomes of cystoprostatectomy from clinical trials. A randomized clinical trial comparing two multimodal treatment regimens of cystoprostatectomy and radiotherapy for T4 prostate cancer with bladder invasion is therefore warranted.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03482089

Sponsor: Tongji Hospital

Primary Outcome Measures:

  • Measure: Overall survival (OS)
  • Time Frame: 10 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Biochemical progression-free survival (BPFS)
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: Cancer-specific survival (CSS)
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: Functional Assessment of Cancer Therapy-General (FACT-G) score
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: Functional Assessment of Cancer Therapy-Prostate (FACT-P) score
  • Time Frame: 10 years
  • Safety Issue:
  • Measure: complications
  • Time Frame: 10 years
  • Safety Issue:

Estimated Enrollment: 70

Study Start Date: June 12, 2018

Eligibility:

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

Inclusion Criteria:

  1. Age ≤75, at the time of randomization
  2. Newly diagnosed primary prostatic adenocarcinoma confirmed by pathological examination of biopsy;diagnosed within 6 months prior to randomization
  3. Untreated for surgery, radiotherapy, or androgen deprivation therapy
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0- 2; American Standards Association (ASA) classification I-III
  5. A life expectation of at least 10 years
  6. Tumor stage (T, M, N): Clinical T4N0M0 with bladder invasion (confirmed by MRI)
  7. Eligible for either treatment of cystoprostatectomy or radiotherapy
  8. Signed informed consent should be obtained from both the patient or one authorized legal relative.

Exclusion Criteria:

  1. Patients with a history of other cancer diagnoses except non-melanoma skin cancer
  2. Patients with pelvic surgery
  3. Patients with severe systemic diseases
  4. severe kidney function -glomerular filtration rate (GFR) < 30 ml/min or elevated liver transaminases above > 10 upper limit of normal (ULN)
  5. Patients who are not able comply with scheduled follow-up visits and examinations with the consideration of patients' physical or mental condition

Contact:

  • Zhiqiang Chen, M.D.,Ph.D
  • 008613995512271

Location:

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan Hubei 430030 China

View trial on ClinicalTrials.gov


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Cytoreductive Prostatectomy Versus Cytoreductive Prostate Irradiation as a Local Treatment Option for Metastatic Prostate Cancer: a Multicentric Feasibility Trial


Condition: Prostate Cancer Metastatic

Intervention:

  • Procedure: radical prostatectomy
  • Radiation: Whole pelvis radiotherapy

Purpose: According to the guidelines of the European Association of Urology (EAU), the first-line treatment for newly diagnosed mPC consists of immediate castration with the addition of docetaxel or abiraterone acetate. As seen in other well-known solid tumours - such as ovarian, colon and renal cancer - local treatment (LT) of the primary tumour could lead to a survival benefit compared to standard of care (SOC). Several retrospective studies have suggested a survival benefit of local treatment of the primary tumour with SOC versus SOC only in mPC. These patients also have less local symptoms of their disease, which has a major impact on quality of life (QoL). Several prospective studies have already been set up to compare either surgery or radiotherapy with the SOC. In expectation of their results and because randomization seems challenging, the investigators want to set up a trial to evaluate the feasibility of randomization between both local treatment groups.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03655886

Sponsor: University Hospital, Ghent

Primary Outcome Measures:

  • Measure: Feasibility of randomization between both treatment arms as assessed by the randomized proportion
  • Time Frame: 48 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: castration-resistant free survival
  • Time Frame: 48 months
  • Safety Issue:

Estimated Enrollment: 86

Study Start Date: August 15, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Male ≥18y
  • Histologically proven PC
  • Newly diagnosed metastatic PC as assessed by standard imaging (CT and bone scintigraphy)
  • ECOG 0-1 (2 if related to local PC symptoms)
  • Eligible for local treatment
  • Written informed consent and able and willing to comply with protocol requirements

Exclusion Criteria:

  • Previous systemic treatment for PC except ADT started within 3 months before randomization
  • Previous radiotherapy to the pelvis interfering with prostate irradiation
  • Previous surgery in the pelvis interfering with radical prostatectomy
  • Symptoms related to metastatic lesions, persisting for at least 2 weeks after initiation of ADT
  • Metastatic brain disease, leptomeningeal disease or imminent spinal cord compression
  • Previous or current malignant disease which is likely to interfere with LoMP II treatment or assessment
  • Psychological disorder intervening with understanding the information or the informed consent

Location:

  • University Hospital Ghent
  • Ghent Belgium

View trial on ClinicalTrials.gov


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A Randomized Phase 2 Trial of Immediate vs. Delayed Anti-CTLA4 Blockade Following Sipuleucel-T Treatment for Prostate Cancer Immunotherapy


Condition: Prostate Cancer

Intervention:

  • Drug: SipT Treatment
  • Drug: Ipilimumab

Purpose: The purpose of this study is to find out what effects taking ipilimumab, as an immediate or delayed treatment, following completion of sipuleucel-T (SipT) treatment, has on patients and their prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01804465

Sponsor: University of California, San Francisco

Primary Outcome Measures:

  • Measure: Impact of the timing of ipilimumab administration on PAP/PA2024specific immune responses by SipT
  • Time Frame: Up to 20 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Prostate Specific Antigen (PSA) Measurements (patient response to therapy)
  • Time Frame: Up to 3 weeks
  • Safety Issue:
  • Measure: Radiographic Clinical Responses
  • Time Frame: Up to 6 months
  • Safety Issue:
  • Measure: Modulation of Effector and Regulatory T Cells
  • Time Frame: Up to 20 weeks
  • Safety Issue:
  • Measure: Safety assessment of combining ipilimumab with SipT
  • Time Frame: up to 3 weeks
  • Safety Issue:

Estimated Enrollment: 54

Study Start Date: January 2014

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically confirmed, metastatic prostate adenocarcinoma (positive bone scan and/or measurable disease on CT scan and/or MRI of the abdomen and pelvis). 2. Progressive disease after androgen deprivation, as defined by PSA Working Group 2 and/or RECIST criteria. Patients must have disease progression by one or both of the following:
  • For patients with measurable disease, progression is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions or the appearance of one or more new lesions, as per RECIST criteria version 1.1.
  • For patients with no measurable disease, a positive bone scan and elevated PSA will be required. PSA evidence for progressive prostate cancer consists of a PSA level of at least 2 ng/ml, which has risen on at least 2 successive occasions, at least 1 week apart. If the confirmatory PSA value is not greater than the screening PSA value, then an additional test for rising PSA will be required to document progression.
  • If no prior orchiectomy has been performed, patients must remain on LHRH agonist or antagonist (e.g. degarelix) therapy. Patients who are receiving an antiandrogen as part of primary androgen ablation must demonstrate disease progression following discontinuation of the antiandrogen, defined as two consecutive rising PSA values, obtained at least two weeks apart, or documented osseous or soft tissue progression. At least one of the PSA values must be obtained at least four weeks (flutamide) or six weeks (bicalutamide or nilutamide) after discontinuation. 3. Laboratory requirements:
  • Absolute neutrophil count (ANC) ≥ 1500/μL
  • Bilirubin < 1.5 x ULN
  • Hemoglobin ≥ 8 g/dL
  • PSA ≥ 2 ng/mL
  • Platelets ≥ 100,000/μL
  • AST and ALT less than or equal to 2.5 x ULN
  • Creatinine clearance ≥ 60mL/min by the Cockcroft Gault equation
  • Testosterone less than or equal to 50 ng/dL 4. Eastern Cooperative Oncology Group (ECOG) performance status 0
  • 1 and life expectancy ≥ 12 weeks. 5. At least 18 years of age or older. 6. Patients receiving any other hormonal therapy, including any dose of megestrol acetate (Megace), Proscar (finasteride), any herbal product known to decrease PSA levels (e.g. Saw Palmetto, PC-SPES), or any systemic corticosteroid, must discontinue the agent for at least four weeks prior to study treatment. Progressive disease as defined above must be documented after discontinuation of any hormonal therapy (with the exception of a LHRH agonist). 7. Prior radiation therapy must be completed ≥ 4 weeks prior to enrollment and the patient must have recovered from all toxicity. Prior radiopharmaceuticals (strontium, samarium) must be completed ≥ 8 weeks prior to enrollment. 8. Because of the unknown potential risk to a gamete and/or developing embryo from these investigational therapies, patients must agree to use adequate contraception (barrier method for males) for the duration of study participation, and for three months after discontinuing therapy.

Exclusion Criteria:

  • 1. Prior chemotherapy for prostate cancer, with the exception of neoadjuvant chemotherapy, because of the potential effect of chemotherapy on the immune system. 2. Prior sipuleucel-T treatment or investigational immunotherapy. 3. Prostate cancer pain requiring regularly scheduled narcotics. 4. Current treatment with systemic steroid therapy (inhaled/topical steroids are acceptable). Systemic corticosteroids must be discontinued for at least 4 weeks prior to first treatment. 5. History of autoimmune disease including, but not limited to:
  • Systemic lupus erythematosis (SLE), scleroderma, CREST syndrome, rheumatoid arthritis
  • Inflammatory bowel disease, celiac disease, primary biliary cirrhosis, autoimmune hepatitis
  • Dermatomyositis, polymyositis, giant cell arteritis
  • Autoimmune hemolytic anemia (AIHA), cryoglobulinemia, antiphospholipid antibody syndrome (APLS)
  • Diabetes mellitus type I, myasthenia gravis, Grave's disease
  • Wegener's granulomatosis or other vasculitis
  • A history of Hashimoto's thyroiditis, psoriasis, or eczema, any of which has been inactive for at least one year, or isolated Raynaud's phenomenon is acceptable 6. Known central nervous system or visceral metastases. 7. Medical or psychiatric illness that would, in the opinion of the investigator, preclude participation in the study or the ability of patients to provide informed consent for themselves. 8. Cardiovascular disease that meets one of the following: congestive heart failure (New York Heart Association Class III or IV), active angina pectoris, or recent myocardial infarction (within the last 6 months). 9. Concurrent or prior malignancy except for the following:
  • Adequately treated basal or squamous cell skin cancer
  • Adequately treated stage I or II cancer from which the patient is currently in complete remission
  • Any other cancer from which the patient has been disease-free for 5 years 10. Known HIV or other history of immunodeficiency disorder. 11. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or medical (e.g. infectious) illness. 12. Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of AEs, such as a condition associated with frequent diarrhea. 13. A history of prior treatment with ipilimumab or prior CD137 agonist or CTLA-4 inhibitor or agonist.

Contact:

  • Paula Dutton
  • 415-885-7871

Locations:

  • University of California San Francisco
  • San Francisco California 94115 United States
  • The University of Texas MD Anderson Cancer Center
  • Houston Texas 77030 United States

View trial on ClinicalTrials.gov


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Phase II Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations (TRIUMPH)


Condition: Prostate Cancer Metastatic

Intervention:

  • Drug: Rucaparib

Purpose: The aim of this research is to find out if the study drug rucaparib leads to lowering of PSA levels in men with metastatic prostate cancer that has not yet been treated with androgen deprivation therapy (also referred to as metastatic hormone sensitive prostate cancer) and who have an inherited mutation in a gene involved in repairing DNA damage. The research will also examine if rucaparib is safe in individuals with metastatic prostate cancer. Prior research studies have shown that drugs like rucaparib can be of benefit to patients with advanced metastatic prostate cancer who are resistant to androgen deprivation therapy AND who carry a mutation in a DNA repair gene. We are studying if rucaparib will be an effective treatment for these patients earlier in their treatment course (for example, prior to the start of medicines that lower testosterone level). It is unknown whether rucaparib will have the same benefit in men with metastatic prostate cancer carrying a mutation in a DNA repair gene, prior to the use of medicines that lower your testosterone level.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03413995

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Primary Outcome Measures:

  • Measure: Response Rate(PSA)to rucaparib for pts with met. hormone sensitive prostate ca harboring germline mutation in homologous recombination DNA repair gene. Measured by decline in PSA to 50% of baseline, confirmed w/second measurement at least 4 weeks apart.
  • Time Frame: 4 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: PSA progression-free survival, defined as a time from initiation of rucaparib therapy until PSA increase of 25 %, confirmed with another measurement at least 3 weeks later
  • Time Frame: 6 months
  • Safety Issue:
  • Measure: Progression-free survival, defined as time from initiation of rucaparib therapy to radiographic or clinical progression or death, whichever comes first.
  • Time Frame: 2 years
  • Safety Issue:
  • Measure: Objective response rate, defined as the proportion of patients achieving a complete or partial response in target lesions found on radiographic scans
  • Time Frame: 2 years
  • Safety Issue:

Estimated Enrollment: 30

Study Start Date: September 10, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.
  • Males aged 18 years of age and above
  • Histological or cytologic proof of adenocarcinoma of the prostate
  • Germline mutation in one or more homologous recombination DNA-repair genes (BRCA1, BRCA2, ATM, CHEK2, NBN, RAD50, RAD51C, RAD51D, PALB2, MRE11, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, FANCM) as documented by a clinical CLIA-grade, genetic test (including but not limited to Invitae, Color Genomics, etc)
  • All patients must be ineligible for or have declined androgen deprivation therapy (ADT)-based systemic treatment
  • Absolute PSA ≥2.0 ng/ml at screening.
  • Radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 8 weeks.
  • Serum testosterone ≥ 100 ng/dl.
  • Participants must have normal organ and bone marrow function measured within 28 days prior to administration of study treatment as defined below:
  • Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (Serum Glutamic Oxaloacetic Transaminase (SGOT)) / Alanine aminotransferase (ALT) (Serum Glutamic Pyruvate Transaminase (SGPT))
  • Participants must have creatinine clearance estimated using the Cockcroft-Gault equation of ≥51 mL/min:
  • Estimated creatinine clearance = (140-age [years]) x weight (kg) serum creatinine (mg/dL) x 72
  • ECOG Performance Status <2
  • Participants must have a life expectancy ≥ 12 months.
  • Male participants and their partners, who are sexually active and of childbearing potential, must agree to the use of two highly effective forms of contraception in combination [see appendix E for acceptable methods], throughout the period of taking study treatment and for 6 months after last dose of study drug to prevent pregnancy in a partner.

Exclusion Criteria:

  • Current active second malignancy (history of non-melanoma skin cancers and superficial bladder cancers are allowed)
  • Prior ADT in the past 6 months. Prior ADT in context of neoadjuvant/adjuvant primary is allowed; prior ADT for biochemical recurrence is also allowed, as long as no ADT has been administered in past 6 months and testosterone has recovered (>100 ng/dl). The total duration of prior ADT should not exceed 24 months.
  • Prior oral anti-androgen (e.g. bicalutamide, nilutamide, enzalutamide, apalutamide), or androgen synthesis inhibitor (e.g. abiraterone, orteronel) in the past 6 months is not permitted. 5-alpha reductase inhibitor therapy (e.g. finasteride, dutasteride) is allowed, as long as subject has been stable on medication for past 6 months.
  • Presence of visceral (i.e. lung or liver) metastases >3cm in long-axis dimension.
  • Pain due to bone metastases requiring narcotic analgesics.
  • Prior treatment with intravenous chemotherapy.
  • Use of any prohibited concomitant medications (Appendix B: Medications With the Potential for Drug-Drug Interactions) within the prior 2 weeks.
  • Involvement in the planning and/or conduct of the study (applies to both Clovis Oncology staff and/or staff at the study site)
  • Previous enrollment in the present study
  • Participation in another clinical study with an investigational product during the last 1 month.
  • Any previous treatment with a PARP inhibitor, including rucaparib.
  • Resting ECG with QTc > 480 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome
  • Persistent toxicities (>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia.
  • Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
  • Major surgery within 2 weeks of starting study treatment, and patients must have recovered from any effects of any major surgery.
  • Poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 6 months) myocardial infarction, uncontrolled major seizure disorder, extensive interstitial bilateral lung disease, or any psychiatric disorder that prohibits obtaining informed consent.
  • Unable to swallow orally administered medication or gastrointestinal disorders likely to interfere with absorption of the study medication.
  • Immunocompromised patients, e.g., patients who are known to be serologically positive for HIV. Known active hepatitis (i.e. Hepatitis B or C) due to risk of transmitting the infection through blood or other body fluids
  • Known hypersensitivity to rucaparib or any of the excipients of the product.
  • Whole blood transfusions in the last 30 days prior to entry to the study.

Contact:

  • Mark Markowski, MD
  • 410-614-0567

Location:

  • Johns Hopkins Hospital
  • Baltimore Maryland 21205 United States

View trial on ClinicalTrials.gov


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A Clinical Research of CAR T Cells Targeting EpCAM Positive Cancer


Condition: Colon Cancer, Esophageal Carcinoma, Pancreatic Cancer, Prostate Cancer, Gastric Cancer, Hepatic Carcinoma

Intervention:

  • Biological: CAR-T cell immunotherapy

Purpose: The purpose of this study is to evaluate the safety and efficacy of EpCAM-specific CAR T Cells infusion for EpCAM positive Cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03013712

Sponsor: First Affiliated Hospital of Chengdu Medical College

Primary Outcome Measures:

  • Measure: Toxicity profile of the EpCAM targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
  • Time Frame: up to 24 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Survival time of anti-EpCAM CAR T cells in vivo
  • Time Frame: up to 24 months
  • Safety Issue:
  • Measure: Anti-tumor efficacy of CAR-T therapy by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
  • Time Frame: up to 24 months
  • Safety Issue:

Estimated Enrollment: 60

Study Start Date: January 2017

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 18 Years maximum 80 Years
  • Gender: All

Inclusion Criteria:

  • 1. Relapsed or refractory EpCAM positive cancer. 2. KPS > 60. 3. Life expectancy>3 months. 4. Gender unlimited, age from 18 years to 80 years. 5. Assessable lesions with a minimum size of 10mm by CT scan or MRI. 6. Acceptable organ function Hematology:
  • Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim.
  • White blood cell (WBC) (> 2000/mm^3).
  • Platelet count greater than 50,000/mm^3.
  • Hemoglobin greater than 9.0 g/dl. 7. No other serious diseases(autoimmune disease, immunodeficiency etc.). 8. Adequate cardiac function (LVEF ≥ 40%). 9. No other tumors. 10. Patients volunteer to participate in the research.

Exclusion Criteria:

  1. Allergic to cytokines.
  2. Uncontrolled active infection.
  3. Acute or chronic GVHD.
  4. MODS.
  5. Treated with T cell inhibitor.
  6. HIV affected.
  7. Pregnancy.

Contact:

  • Yan Zhou, PhD
  • +86-18981941992

Location:

  • IEC of Chengdu Medical College
  • Chendu 610500 China

View trial on ClinicalTrials.gov


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