Prostate Cancer

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A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR)


Condition: Prostate Cancer

Intervention:

  • Drug: Apalutamide
  • Drug: Androgen deprivation
  • Radiation: Salvage radiation therapy
  • Drug: Docetaxel

Purpose: The purpose of this study is to describe the rate of 3-year progression free survival in men with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and apalutamide, AND who have had testosterone recovery to >100 ng/dl at 36 months. The hypothesis is that AR inhibition with apalutamide added to standard salvage external beam radiation with androgen deprivation therapy, as well as the addition of 6 cycles of docetaxel, will further prolong progression free survival.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03311555

Sponsor: Tian Zhang, MD

Primary Outcome Measures:

  • Measure: Progression-free survival (PFS) at 36 months (3 years)
  • Time Frame: 36 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Proportion of subjects with a PSA of <0.1 ng/mL and testosterone recovery
  • Time Frame: 12 months
  • Safety Issue:
  • Measure: Proportion of subjects with a PSA of <0.1 ng/mL and testosterone recovery
  • Time Frame: 24 months
  • Safety Issue:
  • Measure: Proportion of subjects with a PSA of <0.1 ng/mL and testosterone recovery
  • Time Frame: 36 months
  • Safety Issue:
  • Measure: Biochemical progression-free survival
  • Time Frame: 36 months
  • Safety Issue:
  • Measure: Median PSA nadir value
  • Time Frame: 36 months
  • Safety Issue:
  • Measure: Time to Testosterone recovery
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: Percent of subjects with Adverse Events as assessed by CTCAE v4.0
  • Time Frame: up to 36 months
  • Safety Issue:
  • Measure: Percentage of patients completing all treatments
  • Time Frame: 36 weeks
  • Safety Issue:

Estimated Enrollment: 42

Study Start Date: March 28, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically-confirmed diagnosis of prostate adenocarcinoma. Variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate, are not permitted. 2. Gleason sum of 7 (with pT3 disease or positive margins or positive nodes [4 or fewer]), 8, 9, or 10 based on the radical prostatectomy specimen 3. PSA relapse within 4 years of prostatectomy defined by persistently detectable or rising PSA after surgery. 4. Evidence of disease recurrence or progression as evidenced by a PSA > 0.20. This requires 2 consecutive rises in PSA, at least 1 week apart, over the post-prostatectomy nadir OR one PSA value above 0.20 ng/mL IF the patient failed to achieve a post-prostatectomy nadir of < 0.2 ng/mL. 5. Age ≥ 18 years 6. Karnofsky performance status ≥ 80 7. Adequate laboratory parameters
  • Adequate bone marrow function: ANC ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hb >9g/dL
  • AST/SGOT and ALT/SGPT ≤ 2.5 x Institutional Upper Limit of Normal (ULN)
  • Serum bilirubin ≤ 1.5 x Institutional ULN (In subjects with Gilbert's syndrome, if total bilirubin is > 1.5xULN, measure direct and indirect bilirubin and patient is eligible if direct bilirubin ≤ 1.5xULN).
  • Glomerular filtration rate (either estimated or calculated from 24-hour urine collection) ≥ 45 mL/min
  • Serum potassium ≥3.5 mmol/L 8. A minimum of 4 weeks from any major surgery prior to Cycle 1 Day 1. 9. Ability to swallow, retain, and absorb oral medication. 10. Ability to understand and the willingness to sign a written informed consent document. 11. Must use a condom if having sex with a pregnant woman. 12. Male patient 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.

Exclusion Criteria:

  • 1. Radiographic evidence of metastatic disease. Patients with node-positive disease (≤4 positive nodes) at the time of radical prostatectomy are eligible. Patients with pelvic nodes less than 1.5 cm by short axis at the time of screening are eligible. Patients with any enlarged lymph nodes in the retroperitoneum or above the aortic bifurcation or with pelvic nodes ≥ 1.5 cm must be excluded. 2. PSA ≥ 4.0 ng/mL. 3. Testosterone level ≤ 100 ng/dL. 4. More than 1 month of prior hormone exposure or hormone exposure within 30 days of enrollment (up to 1 month of prior LHRH agonist and/or anti-androgen therapy as neoadjuvant therapy prior to prostatectomy is allowed). Prior enzalutamide, apalutamide, ketoconazole, abiraterone, or TAK700 for prostate cancer are prohibited. Prior antiandrogen therapy (including but not limited to bicalutamide, flutamide, nilutamide, enzalutamide, and apalutamide) and prior estrogen therapy (including estrogen patch) are not allowed. All investigational agents are prohibited within 30 days of enrollment. 5. The following medications are prohibited within 2 weeks of enrollment and while on study drug:
  • 5 α-reductase inhibitors (finasteride, dutasteride);
  • Biologic or other agents with anti-tumor activity against prostate cancer;
  • Systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone; oPremedication with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone is permitted prior to docetaxel infusions.
  • Androgens (testosterone, dihydroepiandrosterone [DHEA], etc.) 6. Prior immunotherapy including sipuleucel-T. 7. Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents) 8. History of solid organ or stem cell transplantation. 9. History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, prior head or traumatic brain injury with loss of consciousness, prior or current space-occupying lesion in the brain). Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit. 10. Known or suspected brain metastasis or active leptomeningeal disease. 11. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol. 12. 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 enrollment 13. Sustained uncontrolled hypertension (>150/90 average over 1 week) despite optimal medical management 14. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of apalutamide or increase the risk of radiation (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease). 15. Patients who have received prior prostate or pelvic radiotherapy, including external beam or brachytherapy. 16. Patients who have not recovered from side effects of prior systemic therapy prior to Cycle 1 Day 1. 17. Use of medications known to lower the seizure threshold within 4 weeks prior to study entry. 18. Patients unable or unwilling to abide by the study protocol or cooperate fully with the investigator.

Contact:

  • Julie Rasmussen, MS, RN, 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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Paired CAP: Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer


Condition: Elevated PSA, Prostate Cancer

Intervention:

  • Device: Targeted biopsy

Purpose: This is a pilot study to determine cancer detection rate of conventional/systematic versus targeted biopsy methods in diagnosis of potentially lethal prostate cancer. This is a diagnostic trial using each patient as his own control.

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02425228

Sponsor: Jonsson Comprehensive Cancer Center

Primary Outcome Measures:

  • Measure: Detection of clinically significant cancer
  • Time Frame: one DAY
  • Safety Issue:

Estimated Enrollment: 300

Study Start Date: December 4, 2014

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Eligibility:

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

Inclusion Criteria:

  • Men undergoing a first-time prostate biopsy driven by PSA elevation to rule out cancer.
  • PSA 2.5
  • 20 ng/mL
  • Prostate volume 20
  • 100 cc
  • No prior ablation or TURP
  • Able to tolerate MRI
  • T1c suspect
  • Signed informed consent

Exclusion Criteria:

  • Any prior prostate biopsy
  • Active bleeding disorder or concurrent use of coumadin or any other anticoagulant, unless anticoagulation can be temporarily stopped for at least 7 days before and 7 days after the biopsy
  • Any prostate ablative procedure, including transurethral resection, photovaporization, or electrovaporization
  • Any contraindication to MRI (contrast allergy, severe claustrophobia, MRI-incompatible prosthesis) ,
  • Palpable prostate mass lesion (i.e., Stage >T1c suspected)
  • Any condition that would preclude the subject from getting the required biopsy as stated in the protocol

Contact:

  • Alan Pantuck, M.D.
  • (310) 794-7700

Locations:

  • UCLA
  • Los Angeles California 90095 United States
  • University of California Los Angeles
  • Los Angeles California 90095 United States

View trial on ClinicalTrials.gov


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PSMA-directed endoRadiothErapy of Castration-reSISTant Prostate Cancer (RESIST-PC). A Phase II Clinical Trial


Condition: Metastatic Castration Resistant Prostate Cancer

Intervention:

  • Drug: Lu177-PSMA-617

Purpose: Studies will assess safety and efficacy of 177Lu-PSMA-617 in patients with metastatic castration resistant prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03042312

Sponsor: Endocyte

Primary Outcome Measures:

  • Measure: Determination of number of patients responding to therapy measured by comparison of baseline to follow-up decline in tumor marker level (PSA) ≥50% at 12 weeks.
  • Time Frame: 48 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Determination of the progression-free survival (PFS) measured from the start of therapy until death or PSA progression.
  • Time Frame: 48 months
  • Safety Issue:
  • Measure: Determination of maximum PSA decline
  • Time Frame: 48 months
  • Safety Issue:

Estimated Enrollment: 72

Study Start Date: July 12, 2017

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Prostate cancer proven by histopathology
  2. Unresectable metastases
  3. Progressive disease, both docetaxel naive and docetaxel treated.
  4. Castration resistant disease with confirmed testosterone level ≤50 ng/ml under prior androgen deprivation therapy (ADT)
  5. Positive 68Ga-PSMA-11 PET/CT (positron emission computed tomography ) or diagnostic 177Lu-PSMA-617 scintigraphy
  6. ECOG 0-2
  7. Sufficient bone marrow capacity as defined by WBC (white blood cell ) ≥2.500/μl, PLT (platelet) count ≥100.000/μl, Hb≥9.9 g/dl and ANC≥1500 mm3 for the first cycle and WBC≥2.000/ μl,PLT count ≥75.000/μl, Hb≥8.9 g/dl and ANC≥1000 mm3 for the subsequent cycles
  8. Signing of the Informed Consent Form
  9. Patients enrolling in this trail should have received either Enzalutamide or Abiraterone

Exclusion Criteria:

  1. Less than 6 weeks since last myelosuppressive therapy (including Docetaxel, Cabazitaxel, 223Ra, 153Sm) or other radionuclide therapy.
  2. Glomerular Filtration Rate (GFR) <40 ml/min
  3. Serum creatinine > 1.5 ULN
  4. AST and ALT>5xULN
  5. Urinary tract obstruction or marked hydronephrosis
  6. Diffuse bone marrow involvement confirmed by super-scans

Locations:

  • David Geffen School of Medicine at UCLA
  • Los Angeles California 90095 United States
  • Excel Diagnostics and Nuclear Oncology Center
  • Houston Texas 77042 United States

View trial on ClinicalTrials.gov


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VISION: An International, Prospective, Open Label, Multicenter, Randomized Phase 3 Study of 177Lu-PSMA-617 in the Treatment of Patients With Progressive PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)


Condition: Prostate Cancer

Intervention:

  • Drug: 177Lu-PSMA-617
  • Other: Best supportive/best standard of care

Purpose: The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone. Key secondary objectives are an arm-to-arm comparison of the following: - Radiographic progression-free survival (rPFS) - Response Evaluation Criteria in Solid Tumors (RECIST) response - Time to a first symptomatic skeletal event (SSE) Additional Secondary Objectives: - Safety and tolerability of 177Lu-PSMA-617 - Health-related quality of life (HRQoL; EQ-5D-5L, FACT-P and Brief Pain Inventory - Short Form (BPI-SF)) - Health economics - Progression-free survival (PFS) (radiographic, clinical, or prostate-specific antigen [PSA] progression-free survival) - Biochemical response as measured by PSA. Alkaline phosphatase [ALP] levels and lactate dehydrogenase [LDH] levels will also be measured.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03511664

Sponsor: Endocyte

Primary Outcome Measures:

  • Measure: Overall Survival
  • Time Frame: Every 6-8 weeks until end of treatment and every 3 months during long term follow up [up to 24 months
  • Safety Issue:

Estimated Enrollment: 750

Study Start Date: May 23, 2018

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • To qualify for enrollment, patients must meet the following criteria: 1. Patients must have the ability to understand and sign an approved ICF. 2. Patients must have the ability to understand and comply with all protocol requirements. 3. Patients must be ≥18 years of age. 4. Patients must have an ECOG performance status of 0 to 2. 5. Patients must have a life expectancy >6 months. 6. Patients must have histological, pathological, and/or cytological confirmation of prostate cancer. 7. Patients must have a positive 68Ga-PSMA-11 PET/CT scan, as determined by the sponsor's central reader. 8. Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (<50 ng/dL or <1.7 nmol/L). 9. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone). 10. Patients must have been previously treated with at least 1, but no more than 2 previous taxane regimens. A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a patient has received only 1 taxane regimen, the patient is eligible if: 1. The patient is not willing to receive a second taxane regimen, or 2. The patient's physician deems him unsuitable to receive a second taxane regimen (e.g. frailty assessed by geriatric or health status evaluation or intolerance). 11. Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria: 1. Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL. 2. Soft-tissue progression defined as an increase ≥20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions. 3. Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 PCWG3 criteria, Scher et al 2016). 12. Patients must have≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤28 days prior to beginning study therapy. 13. Patients must have recovered to ≤ Grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.). 14. Patients must have adequate organ function: 1. Bone marrow reserve:
  • White blood cell (WBC) count ≥2.5 x 109/L (2.5 x 10^9/L is equivalent to 2.5 x 10^3/µL and 2.5 x K/µL and 2.5 x 10^3/cumm and 2500/µL) OR absolute neutrophil count (ANC) ≥1.5 x 10^9/L (1.5 x 10^9/L is equivalent to 1.5 x 10^3/µL and 1.5 x K/µL and 1.5 x 10^3/cumm and 1500/µL)
  • Platelets≥ 100 x 10^9/L (100 x 10^9/L is equivalent to 100 x 10^3/µL and 100 x K/µL and 100 x 10^3/cumm and 100,000/µL)
  • Hemoglobin≥ 9 g/dL (9 g/dL is equivalent to 90 g/L and 5.59 mmol/L) 2. Hepatic:
  • Total bilirubin ≤1.5 x the institutional upper limit of normal (ULN). For patients with known Gilbert's Syndrome ≤ 3 x ULN is permitted
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤3.0 x ULN OR ≤5.0 x ULN for patients with liver metastases 3. Renal:
  • Serum creatinine ≤1.5 x ULN or creatinine clearance ≥50 mL/min 15. Albumin >3.0 g/dL (3.0 g/dL is equivalent to 30 g/L) 16. Patients on a stable bisphosphonate or denosumab regimen for ≥30 days prior to randomization are eligible. 17. HIV-infected patients who are healthy and have a low risk of AIDS-related outcomes are included in this trial. For patients who have partners of childbearing potential: 18. Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 3 months after last study drug administration.

Exclusion Criteria:

  • Patients who meet any of the following criteria will be excluded from the study: 1. Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation within 6 months prior to randomization. Previous PSMA-targeted radioligand therapy is not allowed. 2. Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to day of randomization. 3. Any investigational agents within 28 days prior to day of randomization. 4. Known hypersensitivity to the components of the study therapy or its analogs. 5. Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy. 6. Transfusion within 30 days of randomization. 7. Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast). 8. A superscan as seen in the baseline bone scan. 9. Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression. 10. Concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant co-morbid conditions that in the opinion of the investigator would impair study participation or cooperation. 11. Diagnosed with other malignancies that are expected to alter life expectancy or may interfere with disease assessment. Patients with adequately treated non-melanoma skin cancer, superficial bladder cancer and patients with prior history of malignancy who have been disease free for more than 3 years are eligible.

Contact:

  • Richard Messmann, MD
  • 765-476-1070

Locations:

  • UCLA
  • Los Angeles California 90095-7370 United States
  • IU Melvin and Bren Simon Cancer Center
  • Indianapolis Indiana 46202 United States
  • Tulane Cancer Center
  • New Orleans Louisiana 70112 United States
  • Mayo Clinic
  • Rochester Minnesota 55905 United States
  • GU Research Network/ Urology Cancer Center
  • Omaha Nebraska 68130 United States
  • New Mexico Oncology & Hematology Consultants
  • Albuquerque New Mexico 87109 United States
  • Precision Cancer Research/ Dayton Physicians Network
  • Kettering Ohio 45409 United States
  • Excel Diagnostics & Nuclear Oncology Center
  • Houston Texas 77042 United States

View trial on ClinicalTrials.gov


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Prospective National Post-marketing Surveillance for the Investigation of the Efficacy and Safety of SpaceOAR™ to Maintain Space Between the Rectum and Prostate During Radiation Therapy


Condition: Prostate Cancer Patients Treated by Radiotherapy

Intervention:

  • Device: SpaceOAR™ implantation

Purpose: A treatment with SpaceOAR™ hydrogel does reduce late toxicity Grad 2 and Grad 3 of radiation therapy in prostate cancer patients

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01999660

Sponsor: CS Diagnostics GmbH

Primary Outcome Measures:

  • Measure: the rectal complication rate (late toxicity)
  • Time Frame: 6 months and yearly for 5 years thereafter
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Quality of Life
  • Time Frame: 6 months and for 5 years yearly thereafter
  • Safety Issue:

Estimated Enrollment: 250

Study Start Date: November 2013

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Eligibility:

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

Inclusion Criteria:

  • Patient is suffering from pathologically confirmed T1-T2, N0, M0 prostate adenocarcinoma.
  • Patient is intended to receive radiation therapy (3D-computerized radiotherapy, intensity-modulated radiotherapy, and/or brachytherapy) and this will be the first prostate or pelvic radiation therapy.
  • Patient is intended to receive SpaceOAR™ Gel therapy.
  • The patient is official patient of the clinical investigator in the study centre.
  • Patient agrees to fully participate in the clinical trial and give informed consent in writing.

Exclusion Criteria:

  • Anatomic abnormality, physical or pathological condition precluding the implantation.
  • Failure in the wall of the perineum room (with the risk that the hydrogel escapes).
  • History of prostate surgery or local prostate cancer therapy.
  • Rectal injury before implantation of SpaceOAR™ Gel or history of or active inflammatory rectal disease such as Crohn's disease or ulcerative colitis.
  • History of or current perirectal or anal disease or surgery such as prolapsed or bleeding haemorrhoids or fistula.
  • Compromised immune system (e.g., HIV/acquired immunodeficiency syndrome, auto¬immune disease or immunosuppressive therapy).
  • Platelet count, partial thromboplastin time, or white blood cell count out of normal laboratory range.
  • Contraindication for safe MRI and CT scans.
  • Patient is not able to fully participate in this study including the follow-up (e.g. for mental or geographical reasons, or patient is intravenous drug user or has strong potential for non-compliance to medical regimes).
  • Patient is mentally unable to understand the nature, aims, or possible consequences of the clinical investigation.
  • Patient has restricted legal capacity.
  • Patient did participate in another clinical investigation during the last 3 months.
  • Patient has revoked the consent.

Contact:

  • Eike G. Fischer, Dr.
  • +49 241 4500 358

Location:

  • Clinic for Radiooncology and Radiotherapy, Evangelical Clinics Gelsenkirchen
  • Gelsenkirchen NRW 45879 Germany

View trial on ClinicalTrials.gov


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HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer


Condition: Prostate Cancer

Intervention:

  • Drug: Relugolix
  • Drug: Leuprolide Acetate

Purpose: The purpose of this study is to determine the benefit and safety of relugolix 120 mg orally once daily for 48 weeks on maintaining serum testosterone suppression to castrate levels (<=50 ng/dL [1.7 nmol/L] in patients with androgen-sensitive advanced prostate cancer.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03085095

Sponsor: Myovant Sciences GmbH

Primary Outcome Measures:

  • Measure: Sustained Castration Rate
  • Time Frame: 48 weeks
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Castration Rate by Visit
  • Time Frame: 1, 2, and3 weeks
  • Safety Issue:

Estimated Enrollment: 915

Study Start Date: March 3, 2017

Phase: Phase 3

Eligibility:

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

Key Inclusion Criteria:

  1. Has histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate;
  2. Is a candidate for, in the opinion of the investigator, at least 1 year of continuous androgen deprivation therapy for the management of androgen-sensitive advanced prostate cancer with one of the following clinical disease state presentations:
  3. Evidence of biochemical (PSA) or clinical relapse following local primary intervention with curative intent, such as surgery, radiation therapy, cryotherapy, or high-frequency ultrasound and not a candidate for salvage treatment by surgery (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy); or
  4. Newly diagnosed androgen-sensitive metastatic disease; or
  5. Advanced localized disease not suitable for local primary surgical intervention with curative intent (radiotherapy, cryotherapy, or high frequency ultrasound are allowed after 2 months of androgen deprivation therapy);
  6. Has a serum testosterone at the Screening visit of ≥ 150 ng/dL (5.2 nmol/L);
  7. Has a serum PSA concentration at the Screening visit of > 2.0 ng/mL (2.0 μg/L), or, when applicable, post radical prostatectomy of > 0.2 ng/mL (0.2 μg/L) or post radiotherapy, cryotherapy, or high frequency ultrasound > 2.0 ng/mL (2.0 μg/L) above the post interventional nadir;
  8. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at initial screening and at baseline.

Key Exclusion Criteria:

  1. In the investigator's opinion, is likely to require chemotherapy or surgical therapy for symptomatic disease management within 2 months of initiating androgen deprivation therapy;
  2. Previously received GnRH analog or other form of androgen deprivation therapy (estrogen or antiandrogen) for > 18 months total duration. If androgen deprivation therapy was received for ≤ 18 months total duration, then that therapy must have been completed at least 3 months prior to baseline. If the dosing interval of the depot is longer than 3 months, then the prior androgen deprivation therapy must have been completed at least as long as the dosing interval of the depot;
  3. Previous systemic cytotoxic treatment for prostate cancer (eg: taxane-based regimen);
  4. Metastases to brain per prior clinical evaluation;
  5. Scheduled for major surgery after baseline;
  6. History of surgical castration.

Contact:

  • Clinical Trials at Myovant
  • 650-278-8743

Locations:

  • Homewood
  • Homewood Alabama 35209 United States
  • Anchorage
  • Anchorage Alaska 99503 United States
  • Tucson
  • Tucson Arizona 85741 United States
  • San Diego
  • San Diego California 92120 United States
  • Denver
  • Denver Colorado 80211 United States
  • Pompano Beach
  • Pompano Beach Florida 33060 United States
  • Jeffersonville
  • Jeffersonville Indiana 47130 United States
  • Des Moines
  • Des Moines Iowa 50266 United States
  • Wichita
  • Wichita Kansas 67226 United States
  • Towson
  • Towson Maryland 21204 United States
  • Troy
  • Troy Michigan 48084 United States
  • Omaha
  • Omaha Nebraska 68130 United States
  • Las Vegas
  • Las Vegas Nevada 89135 United States
  • Brick
  • Brick New Jersey 08724 United States
  • Lawrenceville
  • Lawrenceville New Jersey 08648 United States
  • Albuquerque
  • Albuquerque New Mexico 87109 United States
  • Brooklyn
  • Brooklyn New York 11215 United States
  • Garden City
  • Garden City New York 11530 United States
  • New York
  • New York New York 10029 United States
  • Plainview
  • Plainview New York 11803 United States
  • Poughkeepsie
  • Poughkeepsie New York 12601 United States
  • Syracuse
  • Syracuse New York 13210 United States
  • Durham
  • Durham North Carolina 27710 United States
  • Winston-Salem
  • Winston-Salem North Carolina 27157 United States
  • Cincinnati
  • Cincinnati Ohio 45212 United States
  • MiddleBurg Heights
  • Middleburg Heights Ohio 44130 United States
  • Toledo
  • Toledo Ohio 43614 United States
  • Oklahoma City
  • Oklahoma City Oklahoma 73104 United States
  • Lancaster
  • Lancaster Pennsylvania 17604 United States
  • Myrtle Beach
  • Myrtle Beach South Carolina 29572 United States
  • Nashville
  • Nashville Tennessee 37209 United States
  • Dallas
  • Dallas Texas 75231 United States
  • San Antonio
  • San Antonio Texas 78229 United States
  • Virginia Beach
  • Virginia Beach Virginia 23462 United States
  • Camperdown
  • Camperdown New South Wales 2050 Australia
  • Darlinghurst
  • Darlinghurst New South Wales 2010 Australia
  • Tweed Heads
  • Tweed Heads New South Wales 2485 Australia
  • Wahroonga
  • Wahroonga New South Wales 2076 Australia
  • Cairns
  • Cairns Queensland 4870 Australia
  • Redcliffe
  • Redcliffe Queensland 4020 Australia
  • Geelong
  • Geelong Victoria 3220 Australia
  • Linz
  • Linz A-4010 Austria
  • Salzburg
  • Salzburg 5020 Austria
  • Edegem
  • Edegem Antwerpen 2650 Belgium
  • Gent
  • Gent Oost-Vlaanderen 9000 Belgium
  • Leuven
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  • Itabuna
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  • Salvador
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  • Salvador
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  • Teresina
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  • Natal
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  • Ijuí
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  • Passo Fundo Rio Grande Do Sul 99010-260 Brazil
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  • Porto Alegre Rio Grande Do Sul 90035-903 Brazil
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  • Porto Alegre
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  • Porto Alegre
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  • Joinville
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  • São Paulo
  • São Paulo 01406 Brazil
  • Calgary
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  • Seoul
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  • Seoul
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  • Seoul
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  • Valencia
  • Valencia 46009 Spain
  • Orebro
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  • Malmo
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  • Stockholm
  • Stockholm Sodermandlands Ian Sweden
  • Uppsala
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  • Kaohsiung
  • Kaohsiung Taiwan
  • Taipei
  • Taipei 112 Taiwan
  • Taipei
  • Taipei 11490 Taiwan
  • Taipei
  • Taipei Taiwan
  • Wirral
  • Wirral Cheshire CH63 4JY United Kingdom
  • Glasgow
  • Glasgow Glasgow City G12 0YN United Kingdom
  • Scunthorpe
  • Scunthorpe North Lincolnshire DN157BH United Kingdom
  • Aberdeen
  • Aberdeen AB25 2ZN United Kingdom
  • Aberdeen
  • Aberdeen AB252ZN United Kingdom
  • Nottingham
  • Nottingham NG5 1PB United Kingdom
  • Plymouth
  • Plymouth PL6 8DH United Kingdom
  • Plymouth
  • Plymouth PL68DH United Kingdom
  • Wrexham
  • Wrexham United Kingdom

View trial on ClinicalTrials.gov


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TheraP: A Randomised Phase 2 Trial of 177Lu-PSMA617 Theranostic Versus Cabazitaxel in Progressive Metastatic Castration Resistant Prostate Cancer (ANZUP Protocol 1603)


Condition: Cancer of the Prostate, Metastatic Cancer

Intervention:

  • Other: 177Lu-PSMA617
  • Drug: Cabazitaxel

Purpose: This open label, randomised, stratified, 2-arm, multicentre, phase 2 trial aims to determine the activity and safety of Lu-PSMA vs cabazitaxel in men with progressive metastatic castration resistant prostate cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03392428

Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Primary Outcome Measures:

  • Measure: Prostate Specific Antigen response rate (PSA RR)
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Pain Response (PPI and Analgesic Score)
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Objective Tumour Response Rate
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Progression free survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: PSA progression free survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Pain progression free survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Radiographic progression free survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Health-related quality of life
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Overall survival
  • Time Frame: Through study completion, on average 4 years
  • Safety Issue:
  • Measure: Frequency and severity of adverse events
  • Time Frame: From first study dose to 12 weeks after completing study treatment
  • Safety Issue:

Estimated Enrollment: 200

Study Start Date: January 29, 2018

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Male aged 18 or older with metastatic adenocarcinoma of the prostate defined by:
  • Documented histopathology of prostate adenocarcinoma OR
  • Metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) 2. Castration-resistant prostate cancer (defined as disease progressing despite castration by orchiectomy or ongoing Luteinizing Hormone-Releasing Hormone (LHRH) analog 3. Progressive disease with rising PSA on 3 consecutive measurements, and PSA ≥ 20 ng/mL 4. Target or non-target lesions according to RECIST 1.1 5. Prior treatment with docetaxel 6. Significant PSMA avidity on 68Ga-PSMA PET/CT, defined as a minimum uptake of SUVmax 20 at a site of disease, and SUVmax > 10 at sites of measurable disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact) 7. ECOG Performance status 0 to 2 8. Assessed by a medical oncologist as suitable for chemotherapy with cabazitaxel 9. Adequate renal function: • Cr Cl ≥ 40mL/min (Cockcroft-Gault formula) 10. Adequate bone marrow function:
  • Platelets ≥ 100 x10 billion /L
  • Hb ≥ 90g/L (no red blood cell transfusion in last 4 weeks)
  • Neutrophils > 1.5 x10 billion/L 11. Adequate liver function:
  • Bilirubin < 1.5 x upper limit of normal (ULN) (or if bilirubin is between 1.5-2x ULN, must have a normal conjugated bilirubin)
  • AST or ALT ≤ 2.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases) 12. Estimated life expectancy > 12 weeks 13. Study treatment both planned and able to start within 21 days of randomisation 14. Willing and able to comply with all study requirements, including all treatments (cabazitaxel or Lu-PSMA); and, the timing and nature of all required assessments 15. Signed, written informed consent

Exclusion Criteria:

  1. Prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components
  2. Site(s) of disease that are FDG positive with minimal PSMA expression defined as FDG intensity > 68Ga-PSMA activity OR 68Ga-PSMA SUVmax < 10
  3. Sjogren's syndrome
  4. Prior treatment with cabazitaxel or Lu-PSMA
  5. Contraindications to the use of corticosteroid treatment
  6. Active malignancy other than prostate cancer
  7. Concurrent illness, including severe infection that may jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety
  8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse
  9. Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception

Contact:

  • Trial Coordinator
  • 61295625363

Locations:

  • Liverpool Hospital
  • Liverpool New South Wales 2170 Australia
  • St Vincent's Hospital
  • Sydney New South Wales 2010 Australia
  • Royal North Shore Hospital
  • Sydney New South Wales 2065 Australia
  • Calvary Mater Newcastle Hospital
  • Waratah New South Wales 2298 Australia
  • Royal Brisbane and Womens Hospital
  • Brisbane Queensland 4029 Australia
  • Royal Adelaide Hospital
  • Adelaide South Australia 5000 Australia
  • Peter MacCallum Cancer Centre
  • Melbourne Victoria 3008 Australia
  • Austin Hospital
  • Melbourne Victoria 3084 Australia
  • Monash Moorabbin Hospital
  • Moorabbin Victoria 3165 Australia
  • Fiona Stanley Hospital
  • Murdoch Western Australia 6450 Australia
  • Sir Charles Gairdner Hospital
  • Nedlands Western Australia 6009 Australia

View trial on ClinicalTrials.gov


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