Prostate Cancer

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A Phase 2 Study of a Checkpoint Inhibitor in Men With Progressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation


Condition: Metastatic Castration Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04104893

Sponsor: VA Office of Research and Development

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Subject must be 18 years of age or older at the time the Informed Consent is signed.
  • The subject (or legally acceptable representative if applicable) must provide written informed consent for the trial.
  • Pathologic diagnosis of prostate cancer of adenocarcinoma or small cell histology.
  • Metastatic disease as documented by technetium-99m (99mTc) bone scan or metastatic lesions by computed tomography (CT) or magnetic resonance imaging (MRI) scans (visceral or lymph node disease). CT-portion of FDG-PET/CT or scan may be used for eligibility. NaF PET-CT is an alternative to 99mTc bone scan. If lymph node metastasis is the only evidence of metastatic disease, it must be 1.5 cm in short axis and above the level of the iliac bifurcation. Imaging studies for the purpose of determining eligibility must be completed within 60 days of Day 1.
  • Progressive castration resistant prostate cancer as defined by serum testosterone < 50 ng/mL and one of the following:
  • PSA progression confirmed per Prostate Cancer Clinical Trials Working Group (PCWG3),
  • Radiographic progression of soft tissues according to Response Evaluation Criteria in Solid Tumors, version 1.1 (iRECIST 1.1) modified based on PCWG3, or radiographic progression of bone according to PCWG3.
  • Prior use of a novel AR signaling inhibitor for 4 weeks, including abiraterone acetate plus prednisone/prednisolone, enzalutamide, apalutamide, and/or darolutamide. NOTE: These AR signaling inhibitors may have been used for mCSPC, M0CRPC, and/or mCRPC.
  • Ongoing surgical or medical castration, with testosterone levels of <50 ng/dL. If the subject is being treated with GnRH analogs (subject who has not undergone bilateral orchiectomy), this therapy must have been initiated at least 30 weeks prior to initiation of pembrolizumab and must be continued throughout the study.
  • ECOG PS grade of 0-1.
  • Metastatic lesion that is amenable to biopsy and performed within 180 days of Day 1.
  • dMMR or CDK12-/- as determined by somatic tumor DNA NGS.
  • Either monoallelic or biallelic inactivation of CDK12 on NGS is considered sufficient for eligibility purposes.
  • MMR genes include: MLH1, MSH2, MLH3, PMS1, MSH6, and PMS2.
  • dMMR is established by MSI-H on NGS. However, for "weak" MMR genes, inclusive of PMS2 and MSH6, monoallelic inactivation will be allowed for eligibility purposes if and only if there is at least MSI-low or hypermutation that is concomitantly present.
  • If there is biallelic inactivation of "strong" MMR genes (MLH1 and MSH2), then patients must manifest MSI-H. However, if the tumor DNA utilized for MSI analysis was obtained > 6 months prior to NGS, then the NGS should be repeated to determine if MSI-H has developed. Monoallelic inactivation of "strong" MMR genes will be allowed if MSI-H is present; in this scenario, it is presumed that biallelic inactivation is present but the second inactivating event was not detected due to technical issues such as low sensitivity for copy loss.
  • Adequate organ function:
  • Hemoglobin (hgb) > 9.0 g/dL,
  • Absolute neutrophil count (ANC) > 1500/ uL,
  • Platelets > 100,000/ uL,
  • Total bilirubin 1.5 x ULN OR direct bilirubin ULN for participants with total bilirubin levels >1.5 x ULN
  • ALT and AST 2.5 x ULN ( 5 x ULN for participants with liver metastases) (Child-Pugh class A and B allowed; Child-Pugh class C is excluded).
  • Creatinine < (2.0 mg/dL) during screening evaluation (>2.0 is allowed if EGFR >30 mL/min/1.73 m2).
  • Subject must agree to use contraception during the treatment period plus an additional 120 days after the last dose of study treatment and must refrain from donating sperm during this period.

Exclusion Criteria:

  • Brain metastases.
  • Prior treatment with an anti-PD1, anti-PDL1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
  • Anti-neoplastic therapies for prostate cancer must be completed > 2 weeks prior to Day 1 (initiation of pembrolizumab); chemotherapy must be completed > 4 weeks prior to Day 1.
  • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks [could consider shorter interval for kinase inhibitors or other short half-life drugs] prior to [randomization /allocation]. Note: Participants must have recovered from all AEs due to previous therapies to Grade 1 or baseline. Participants with Grade 2 neuropathy may be eligible.
  • Herbal and non-herbal products that may decrease PSA levels other than medical castration and megestrol (up to 40 mg/day is allowed) for hot flashes.
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation ( 2 weeks of radiotherapy) to non-CNS disease.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • If a subject has undergone major surgery, they must have recovered adequately from the toxicities or complications from the intervention within 4 weeks prior to starting therapy.
  • History of non-prostate active malignancy requiring treatment in the 24 months prior to Day 1 except for non-muscle invasive urothelial cancer and non-melanoma skin cancer.
  • Active infection or conditions requiring treatment with antibiotics.
  • Immunosuppressive doses of systemic medications, such as corticosteroids (doses > 10 mg/day prednisone or equivalent), within 2 weeks of Day 1.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Active autoimmune disease or a documented history of autoimmune disease that requires immunosuppressive medications within the last two years (e.g., chronic steroids, methotrexate, tacrolimus, etc.).
  • Active or chronic hepatitis B or hepatitis C disease as determined by hepatitis B surface antigen (HBsAg), hepatitis B core antibody, or hepatitis C antibody (anti-HCV) positivity at screening. If positive, further testing of quantitative levels to rule out active infection is required.
  • History of positive test for human immunodeficiency virus (HIV). NOTE: Hepatitis B and C and HIV testing is NOT required during screening.
  • Vaccinated with a live vaccine within 30 days of enrollment.
  • Has severe hypersensitivity ( Grade 3) to pembrolizumab and/or any of its excipients.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Subject is planning to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.

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Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04122976

Sponsor: Bayer

Phase:

Eligibility:

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

Inclusion Criteria:

  • Men over the age of 18 years
  • Histologically or cytologically confirmed adenocarcinoma CRPC defined by disease progression despite ADT and may present as a confirmed rise in serum PSA levels (as defined by PCWG3: Rising PSA values at a minimum of 1-week intervals, and a baseline PSA value ≥ 1.0 ng/mL). For patients with a prior ARi treatment (Enzalutamide or Apalutamide), there is no baseline PSA value required
  • No evidence of metastasis based on conventional imaging. An imaging assessment needs to be obtained prior to the 1st dose of darolutamide. For patients with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC, M0 status with no evidence of disease progression should be confirmed within 3 months of ARi discontinuation
  • Decision to initiate treatment with darolutamide was made as per investigator's routine treatment practice prior to enrollment in the study
  • Signed informed consent
  • Life expectancy of ≥3 months
  • For a patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for less than one year, all toxic effects from prior use of any ARi treatment have to be resolved at the time of enrollment and prior to the 1st dose of darolutamide

Exclusion Criteria:

  • Participation in an investigational program with interventions outside of routine clinical practice
  • Contraindications according to the local marketing authorization
  • Previous treatment with darolutamide (more than 3 days prior to enrollment)
  • Patient with a prior ARi treatment (Enzalutamide or Apalutamide) for nmCRPC for more than one year

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Oligomet-DK. National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients


Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04086290

Sponsor: Peter Busch Østergren

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Age 18 years or older and willing and able to provide informed consent;
  2. Stage cT1 ≤ cT3b, Clinical resectable
  3. Gleason score ≥ 6
  4. M1
  5. ≤ 3 bone metastases localized to the spine, pelvis or humeral/femoral bones as evaluated by 68Ga-PSMA PET/CT and magnetic resonance imaging (MRi)
  6. Absence of PSMA uptake in retroperitoneal lymph nodes, (outside the anatomical region of extended pelvic lymph node dissection as described in the European Association of Urology (EAU) guidelines.
  7. No visceral metastasis
  8. Metastases suitable for stereotactic body radiotherapy
  9. Non symptomatic bone lesions
  10. Eligible for surgery

Exclusion Criteria:

  1. Prior curative intended treatment for prostate cancer
  2. Prior androgen deprivation therapy (ADT)
  3. History of another invasive cancer within 3 years of screening, with the exception of fully treated cancers with a remote probability of recurrence. The medical monitor and investigator must agree that the possibility of recurrence is remote for exceptions.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status > 1
  5. Evaluated not able to fulfil the study protocol.
  6. Contraindications against MRI

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DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04136353

Sponsor: University of Sydney

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • 1. Men aged 18 years and older, with pathological diagnosis of adenocarcinoma of the prostate 2. EITHER planned for primary RT and judged to be at very high risk for recurrence based on any of the following:
  • Grade Group 5, OR
  • Grade Group 4 AND one or more of the following: clinical T2b-4 OR MRI with seminal vesicle invasion OR extracapsular extension OR PSA* > 20ng/mL, OR
  • Pelvic nodal involvement (involvement of lymph nodes (LNs) at or below the bifurcation of the aorta into the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or pathologically confirmed (PSMA PET alone is not considered enough if ≤ 10mm) OR Post-radical prostatectomy ≤ 365 days prior to randomisation and planned for RT with PSA* ≥ 0.1 ng/mL that has risen or remained stable (within ≤ 0.05 ng/mL) since a previous level at least 1 week earlier, judged to be at very high risk for recurrence based on any of the following:
  • Grade Group 5, OR
  • Grade Group 4 AND pT3a or higher, OR
  • Pelvic nodal involvement (involvement of LNs at or below the bifurcation of the aorta into the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or pathologically confirmed (PSMA PET alone is not considered enough if ≤ 10mm) * This PSA level must be measured within 60 days prior to randomisation. However, if a participant has already commenced endocrine therapy (ET) for prostate cancer, this PSA level must be measured within 180 days prior to commencing ET. 3. Adequate bone marrow function: Haemoglobin ≥ 100g/L, white cell count (WCC) ≥ 4.0x109/L, absolute neutrophil count (ANC) ≥ 1.5x109/L and platelets > 100 x 109/L 4. Adequate liver function: alanine aminotransferase (ALT) < 2 x upper limit of normal (ULN) and total bilirubin < 1.5 x ULN, (or if total bilirubin is between 1.5
  • 2 x ULN, they must have a normal conjugated bilirubin) 5. Adequate renal function: calculated creatinine clearance > 30 mL/min (Cockroft-Gault) 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0
  • 1 7. Study treatment both planned and able to start within 7 days after randomisation 8. Willing to complete health-related quality of life (HRQL) questionnaires UNLESS is unable to complete because of literacy or limited vision 9. Willing and able to comply with all study requirements, including standard of care treatment such as EBRT, timing and/or nature of required assessments 10. Signed, written informed consent

Exclusion Criteria:

  • 11. Prostate cancer with predominant non-adenocarcinoma features (sarcomatoid or spindle cell or neuroendocrine small cell or squamous cell components or other non-adenocarcinoma) 12. Involvement of LNs by conventional CT imaging superior to the common iliac artery bifurcation, and/or outside the pelvis (distant LNs). LN involvement is defined by histopathological confirmation, or by a short axis measurement > 10mm on standard imaging (CT or MRI, but not PET). 13. Evidence of metastatic disease. Minimum imaging requirements to exclude metastatic disease are diagnostic quality imaging of both the pelvis and the abdomen (CT or MRI), chest (CXR or CT), and a whole body radioisotope bone scan (WBBS).
  • If endocrine therapy (ET) had not started, imaging must be within 60 days prior to randomisation.
  • If ET has been started, imaging must have been performed no more than 60 days prior to starting ET and no more than 30 days after starting ET and prior to randomisation. 14. PSA > 100 ng/mL at any time 15. Any prior use of new generation potent AR inhibition (abiraterone, enzalutamide, apalutamide, darolutamide or similar agents). 16. Prior endocrine therapy for prostate cancer except for the following which are allowed:
  • (i) LHRHA and/or (ii) a first-generation nonsteroidal antiandrogen (NSAA) are allowed if commenced no more than 90 days before randomisation. If an NSAA has been used, it must be stopped before starting study treatment with darolutamide/placebo; and
  • Prior use of 5-alpha reductase inhibitor is allowed and if used it must be stopped before starting study treatment with darolutamide/placebo 17. Bilateral orchidectomy 18. Prior pelvic brachytherapy or other radiotherapy that would result in an overlap of radiotherapy fields that would preclude the required RT 19. History of
  • Loss of consciousness or transient ischemic attack or stroke within 6 months prior to randomisation, or
  • Significant cardiovascular disease within 6 months prior to randomisation: including myocardial infarction, unstable angina, congestive heart failure (NYHA grade II or greater), ongoing arrhythmias of Grade > 2 (CTCAE v5.0), thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism), coronary artery bypass graft. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed. 20. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of darolutamide, including difficulty swallowing tablets 21. History of another malignancy within 5 years prior to randomisation except for those malignancies treated with curative intent with a predicted risk of relapse of less than 10% including but not limited to non-melanoma carcinoma of the skin; or adequately treated, non-muscle-invasive urothelial carcinoma of the bladder (i.e. Tis, Ta and low grade T1 tumours). All such cases with a history of malignancy within the last 5 years are to be discussed with study team before randomisation. Melanoma in-situ and other adequately treated in-situ neoplasms are not considered malignancies for the purposes of eligibility assessment. 22. Concurrent illness, including severe infection that might jeopardise the ability of the participant to undergo the procedures outlined in this protocol with reasonable safety (HIV infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant darolutamide) 23. 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 24. Patients who are sexually active with women of child-bearing potential and not willing/able to use medically acceptable and highly effective forms of contraception during study treatment and for at least 4 weeks after completion of study treatment. Contraception must include:
  • Condom use (also required if sexual partner is pregnant), and
  • Additional birth control with low failure rate (less than 1% per year) when used consistently and correctly. E.g. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, true sexual abstinence. True sexual abstinence will only be an acceptable form of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study treatment, and withdrawal are not acceptable methods of contraception. 25. Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases 26. Major surgery within 21 days prior to randomisation 27. Patients with history of hypersensitivity to the study treatment

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Identifying the Optimal Biopsy Scheme at MRI Target Biopsy


Condition: Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04183699

Sponsor: IRCCS San Raffaele

Eligibility:

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

Inclusion Criteria:

  • Male patients, aged between 18 and 80 years old with suspicion of prostate cancer
  • Presence of a positive mpMRI of the prostate (visible lesion PI-RADS ≥ 3)
  • Serum PSA ≤ 20ng/ml
  • Suspected stage ≤ T2 on rectal examination (organ confined prostate)
  • Fit to undergo a prostate biopsy
  • Able to understand and willing to sign a written informed consent document

Exclusion Criteria:

  • Prior positive prostate biopsy
  • Prior treatment of the prostate
  • Prostate volume <30 ml at mpMRI of the prostate
  • More than one lesion at mpMRI of the prostate
  • Contraindication to prostate biopsy

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An Open Label, Randomized, Phase III Study, Evaluating the Efficacy of a Combination of Apalutamide With Radiotherapy and LHRH Agonist in High-risk Postprostatectomy Biochemically Relapsed Prostate Cancer Patients


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04181203

Sponsor: UNICANCER

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  1. Patients must have signed a written informed consent form prior to any trial specific procedures
  2. Age ≥18 years old and ≤80 years old
  3. Histologically confirmed diagnosis of prostate adenocarcinoma treated primarily with radical prostatectomy
  4. Pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx])
  5. Tumor stage pT2, pT3 or pT4* (*only in case of bladder neck involvement)
  6. Patients should have no clinical and radiological signs (18FCH-PET CT-scan or 68Ga-PSMA-PET CT-scan) of metastatic disease. Patients with a local relapse detected on PET CT-scan can be randomized
  7. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  8. PSA ≥0.2 ng/mL at the time of randomization with an elevation of PSA over three consecutive assays. PSA increases over a 1-month interval minimum
  9. At least 3 months between radical prostatectomy and randomization.
  10. High-risk features as defined by at least one of these characteristics: PSA at relapse >0.5 ng/mL or Gleason score >7 or tumor stage pT3b or resection margins R0 or PSA doubling time ≤6 months
  11. Adequate renal function: serum creatinine <1.5 x upper limit of normal (ULN) or a calculated corrected creatinine clearance ≥60 mL/min according to the Cockcroft-Gault formula, creatinemia <2 ULN
  12. Adequate hepatic function: total bilirubin ≤1.5 x ULN (unless documented Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x ULN
  13. Patients with QTc prolongation <500 ms, inclusion should considered after close benefit/risk assessment and cardiologist advice
  14. Patients with female partners of reproductive potential should agree to use effective contraceptive method during treatment period and for 3 months after the last dose of apalutamide or for 6 months after the last fraction of radiotherapy
  15. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
  16. Patients must be affiliated to the Social Security System

Exclusion Criteria:

  1. Histologically proven lymph nodes involvement at initial lymphadenectomy: pN1, pN2, pN3
  2. Previous treatment with hormone therapy for prostate cancer
  3. Histology other than adenocarcinoma
  4. Surgical or chemical castration
  5. Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has been cured for at least 5 years
  6. Previous pelvic radiotherapy
  7. History of Inflammatory bowel disease or any malabsorption syndrome or conditions that would interfere with enteral absorption
  8. Uncontrolled hypertension (defined as systolic blood pressure (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
  9. Clinically significant history of liver disease consistent with Child-Pugh class B or C
  10. History of seizure or condition that may pre-dispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
  11. Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to study entry
  12. Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g pulmonary embolism, cerebrovascular accident including transient ischemic attacks) or clinically significant ventricular arrhythmias within 6 months prior to randomization
  13. Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (e.g, heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval >500 ms at baseline
  14. Medications known to prolong QTc
  15. Known hypersensitivity to apalutamide or to any of its components
  16. Galactosemia, Glucose-galactose malabsorption or lactase deficiency
  17. Inability or willingness to swallow oral medication
  18. Individual deprived of liberty or placed under the authority of a tutor
  19. Patients already included in another therapeutic trial with an experimental drug or having been given an experimental drug within the 30 days before inclusion

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A Phase II Study of the Addition of Opaganib to Androgen Antagonists in Patients With Prostate Cancer Progression on Enzalutamide or Abiraterone


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04207255

Sponsor: Medical University of South Carolina

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Patient must have mCRPC. Each patient must have:
  • Tissue diagnosis documented by pathology report, or clinic note attesting to same.
  • Radiographically-demonstrated metastases
  • Patients must have adenocarcinoma, or ductal carcinoma, or combinations of these two entities 2. Voluntary, signed and dated, institutional review board (IRB)-approved informed consent form in accordance with regulatory and institutional guidelines. 3. Documented progression during treatment with enzalutamide or abiraterone, as determined by the enrolling investigator. 4. Testosterone level documented to be less than 50ng/ 5. 18 years of age or older. 6. ECOG performance status of 0-2. 7. Acceptable liver function:
  • Bilirubin ≤ 1.5 times upper limit of normal (CTCAE Grade 1 baseline)
  • AST (SGOT) & ALT (SGPT) ≤ 3 x ULN (CTCAE Grade 1 baseline)
  • Subjects with Gilbert's syndrome may be included if the total bilirubin is <3x ULN and the direct bilirubin is within normal limits 8. Acceptable kidney function indicated by serum creatinine ≤ 1.5 X ULN (CTCAE Grade 1 baseline) 9. Acceptable hematologic status:
  • Absolute neutrophil count ≥ 1000 cells/mm3,
  • Platelet count ≥ 75,000 (plt/mm3) (CTCAE Grade 1 baseline)
  • Hemoglobin ≥ 9.0 g/dL. 10. Fasting blood glucose of <165mg/dL 11. Urinalysis: no clinically significant abnormalities 12. International normalized ratio (INR) ≤1.7 13. Well-controlled blood pressure as determined by the treating investigator 14. Patients requiring narcotic analgesics must be on stable doses for at least 2 weeks prior to study entry.

Exclusion Criteria:

  1. New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on ECG.
  2. Underlying psychiatric disorder requiring hospitalization within the last two years.
  3. Clinically significant neurological disorder (Parkinson's disease, dementia, multiple sclerosis), as determined by the enrolling investigator.
  4. Active, uncontrolled bacterial, viral or fungal infection, requiring systemic therapy.
  5. Treatment with radiation therapy, surgery, or investigational therapy within 28 days prior to registration.
  6. Unwillingness or inability to comply with procedures required in this protocol.
  7. Serious nonmalignant disease that could compromise protocol objectives in the opinion of the Investigator.
  8. Patients who are receiving coumadin, apixaban, argatroban or rivaroxaban. Patients who are receiving other drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes that cannot be stopped at least 7 days or 5 half-lives (whichever is longer) before starting treatment with opaganib may be treated on this study with careful monitoring for toxic effects or loss of efficacy of the relevant drug. A list of commonly used drugs that are sensitive substrates of CYP450 1A2, 3A4, 2C9, 2C19 or 2D6, or strong inhibitors or inducers of all major CYP450 isozymes with the half-life of each drug identified, is included as an Appendix C.
  9. Patients who are currently participating in any other clinical trial of an investigational product.
  10. Other primary malignancy requiring systemic treatment within past 5 years except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancer.
  11. Any other mental incapacitation or psychiatric illness that would preclude study participation, as determined by the enrolling investigator.
  12. Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.

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Postoperative Hypofractionated Radiation Therapy and Hormonal Therapy in Patients With Prostate Cancer: A Phase II Trial


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04249154

Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically proven high risk (any of the following risk factors: surgical positive margins; extra-capsular extension; seminal vesicle involvement, Gleason score >7) adenocarcinoma of the prostate after a radical prostatectomy as primary treatment (adjuvant group), with pathologically negative lymph nodes dissection or clinically negative lymph nodes by imaging [pelvic and abdominal computed tomography (CT) scan, or magnetic resonance imaging (MRI)]. Lymphadenectomy is not mandatory. Any type of prostatectomy will be permitted. For this group of patients, the PSA level at time of entry must be below 0.4 ng/ml
  • Histologically proven adenocarcinoma after a radical prostatectomy with pathologically negative lymph nodes (lymphadenectomy is not mandatory) or clinically negative lymph nodes by imaging (pelvic and abdominal CT scan, or MRI or) and evidence of biochemical failure (defined as two consecutives rises of the PSA, at any PSA level). PSA upper limit post-prostatectomy must be below 2.0 ng/ml (salvage group). Any type of prostatectomy will be permitted
  • Negative bone metastases proven by bone scan. The use of proton emission tomography (PET) fluoride is allowed
  • History and physical examination (including digital rectal exam) within 90 days prior of registration
  • Adequate marrow reserve defined as: Hemoglobin ≥ 10 g/dl (patients may be transfused in order to achieve this level); Platelets ≥ 100 000 cells/mm3 and a white blood cell count of ≥ 4000 cells/ml3
  • AST or ALT <2 x the upper limit of normal
  • PSA and testosterone levels within one month of registration Age ≥ 18
  • Zubrod Performance Status 0-1
  • Patients must sign a study-specific consent form

Exclusion Criteria:

  • Previous exposure to androgen deprivation
  • Chemotherapy before or after prostatectomy
  • Prior pelvic radiotherapy
  • Previous malignancies (except non-melanomatous skin cancer) unless disease-free >5 years
  • Severe, active medical condition that makes the use of any of the therapies of the study not recommended

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Developing and Testing an Interactive Decision Aid for Newly Diagnosed Prostate Cancer Patients


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04260737

Sponsor: Reykjavik University

Eligibility:

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

Inclusion Criteria:

  • Newly diagnosed with localized prostate cancer.

Exclusion Criteria:

  • Reads and understands Icelandic
  • Can give informed consent

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Prospective Randomized Trial to Evaluate the Prognostic Role of Lymphnode Dissection in Men With Prostate Cancer Treated With Radical Prostatectomy (Predict-Study)


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04269512

Sponsor: Martini-Klinik am UKE GmbH

Eligibility:

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

Inclusion Criteria:

  • localized intermediate risk prostate cancer (intermediate risk (PSA> 10 ng / ml
  • 20 ng / ml or Gleason score 7 or cT category 2b)
  • scheduled for open radical prostatectomie or DaVinci prostatectomie

Exclusion Criteria:

  • American Society of Anesthesiology Classification> 3
  • Existing contraindications for performing a lymph node dissection
  • Neoadjuvant hormone therapy

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Prebiopsy Magnetic Resonance Imaging in Men With Suspicion of Prostate Cancer - A Multi-centre Trial on Clinical Utility of IMPROD bpMRI in a Shared Decision Making Setting


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04287088

Sponsor: Turku University Hospital

Eligibility:

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

Inclusion Criteria:

  • Age: 18 years or older
  • Language spoken: Finnish
  • Clinical suspicion of prostate cancer, based on: serum level of PSA from 2,5 ng/ml to 20 ng/ml and/or abnormal digital rectal examination according to the referral physician
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

  • previous diagnosis of prostate cancer
  • any contraindications for MRI
  • any other conditions that might compromise patient's safety, based on the clinical judgment of the responsible urologist
  • bilateral hip prosthesis

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A Phase I/II Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib in Patients With Metastatic Castration-resistant Prostate Cancer Following Standard of Care Treatment


Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04060394

Sponsor: Laekna Limited

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Patients, males ≥18 years of age, must be able to provide written informed consent. 2. Patients must have documented histological or cytological evidence of adenocarcinoma of the prostate (excluding neuroendocrine differentiation or small cell histology). 3. Patients must have radiographic evidence of metastatic disease for mCRPC based on the 'Guideline of American Urological Association for Prostate Cancer' before study enrollment. (https://www.auanet.org/guidelines/prostate-cancer-castration-resistant11 guideline) 4. For PTEN and PIK3CA/AKT status test: Phase I: The PTEN/PIK3CA/AKT status test is optional and the result could be either positive, negative, undetermined or invalid. Phase II: Patients will be allowed to enroll regardless of the biomarker status, medical monitor review is necessary before enrollment. The biomarker status tests will be performed with the following order. The biomarker results of all enrolled patients will be used for retrospective analysis purposes.
  • Patients that have a documentation of "PTEN LOSS" and/or PTEN/PIK3CA/AKT alteration from a previous test on either tissue or liquid biopsy (e.g., IHC or next generation sequencing NGS), no further biomarker tests are needed in this study.
  • Patients who have PTEN or PI3KPIK3CA/AKT alteration status reported other than "PTEN LOSS", "PIK3CA/AKT alterations" or never completed any PTEN/PIK3CA/AKT test before, could either provide the archival tumor samples collected at any time before study enrollment or do a fresh core tumor biopsy.
  • As the last option, patients can perform a liquid biopsy for PTEN LOSS and PTEN/PIK3CA/AKT alteration tests by NGS of cfDNA if they have no archival tissue to provide, no tumor lesion for biopsy or a fresh biopsy is not feasible. 5. Patients must have progressive disease based on the PCWG3 criteria:
  • Patients who progressed based solely on total PSA rising, should have had a sequence of rising values on 3 consecutive occasions of at least 1-week intervals (if the third measurement is not greater than the second measurement, a fourth measurement at least a week apart must be taken and must be greater than the second measurement) and should have 2.0 ng/mL minimum level for entry. Note: Patient must have had a prior PSA response, followed by documented PSA progression on prior hormone treatment.
  • Patients who have documented disease progression per RECIST 1.1 are eligible independent of PSA.
  • Patients with bone only progression according to PCWG3 (i.e., bone scan showing appearance of ≥2 new lesions). 6. Patients must have castration levels of testosterone (<50 ng/dL or 1.7 nmol/L). Note: Patients must have undergone androgen deprivation therapy (ADT), such as orchiectomy, or have been on luteinizing hormone releasing hormone (LHRH) agonists or antagonists, for at least 3 months prior to study enrollment. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study. 7. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2. 8. Patients must have adequate hematopoietic function by local laboratory within the 28 days before enrollment, as evidenced by:
  • Absolute neutrophil count ≥1,500/μL
  • Platelet count ≥75,000/μL
  • Hemoglobin ≥9 g/dL 9. Note: Criteria must be met without growth factors or transfusion within 10 days prior to the screening lab tests. Total serum bilirubin ≤1.5 × ULN within the 28 days before enrollment (in patients with known Gilbert's syndrome, total bilirubin ≤3 × ULN with direct bilirubin ≤1.5 × ULN). 10. Aspartate aminotransferase and alanine aminotransferase ≤2.5 × ULN except for patients with tumor involvement of the liver who must have AST and ALT ≤5 × ULN within the 28 days before enrollment. 11. Patients must have adequate renal function as evidenced by a serum creatinine of ≤1.5 × ULN for the reference laboratory or creatinine clearance ≥30 mL/min within the 28 days before enrollment (calculated from Cockcroft-Gault formula or 24-hour urine collection). 12. Serum potassium ≥3.5 mmol/L and < ULN within the 28 days before enrollment. 13. Fasting plasma glucose (fasting is defined as no caloric intake for at least 8 hours):
  • ≤126 mg/dL for those patients without a pre-existing diagnosis of Type 1 or Type 2 diabetes mellitus
  • ≤167 mg/dL for those patients with a pre-existing diagnosis of Type 2 diabetes mellitus AND glycosylated haemoglobin (HbA1C) ≤8% 14. Phase I: Patients who have mCRPC progressed or are intolerant after receiving at least 1 prior treatments of any anti-androgen (such as abiraterone, enzalutamide, apalutamide, or any other AR antagonists that are approved later), and/or chemotherapy. Patients must have at least 3 weeks of treatment of any antiandrogen and/or completed at least 4 Cycles of docetaxel or cabazitaxel treatment before their screening visit. Phase II: Patients who have mCRPC progressed or are intolerant after receiving 1-3 prior standard treatments for mCSPC, or nmCRPC, or mCRPC, including at least one second-generation antiandrogen treatment (i.e., abiraterone, enzalutamide, apalutamide, or darolutamide), and no more than one chemotherapy. Patients must have at least 3 weeks of treatment of any antiandrogen and/or completed at least 3 Cycles of docetaxel or cabazitaxel treatment and/or at least 3 injections of R223 and/or at least 2 injections of sipuleucel-T to be counted as one prior therapy. Patient's current diagnosis at screening must be mCRPC. 15. Concomitant use of bisphosphonates and other bone supportive agents is allowed if the dose and renal function have been stable for at least 12 weeks before enrollment and no related ≥Grade 2 side effects are present for at least 4 weeks prior to study drug treatment. The minimum washout period is 4 weeks for prostate cancer therapy (cytotoxic, biologics, antiandrogens, etc.) before enrollment, starting from the day the therapies were stopped. 16. Patients with a female partner of childbearing potential must agree to use condoms plus an additional contraceptive method to avoid conception until the end of relevant systemic exposure plus 90 days following the Clinical Trial Facilitation Group contraception guideline from September 2014. 17. Patient should be suitable for oral medication and should not have any known gastrointestinal diseases that may interfere with drug absorption. 18. Life expectancy of at least 6 months.

Exclusion Criteria:

  • 1. Major surgery within 28 days before study treatment and/or have not adequately (Grade 1) recovered from the adverse effects of any major surgical procedures before study treatment. 2. Patients that received other second-line ADT (including but not limited to ketoconazole and amino glutethimide) within 6 weeks before enrollment. 3. Patients who have completed sipuleucel-T (Provenge®) treatment within 6 weeks of enrollment. 4. Patients who have received antiandrogens such as flutamide (EULEXIN®), bicalutamide (CASODEX®), or nilutamide (NILANDRON®) for >3 months must be off treatment for 6 weeks prior to enrollment and should demonstrate a continued rise in PSA after withdrawal. 5. Patients who have received Radium Ra 223 dichloride (XOFIGO®) must be off therapy for 7 weeks prior to enrollment or Samarium Sm 153 lexidronam (QUADRAMET®) must be off therapy for at least 2 weeks prior to enrollment. 6. Patients that are currently receiving increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent, other than the following: daily use of up to 10 mg prednisone (or equivalent) or low-dose steroid for the control of nausea and vomiting, topical steroid, or inhaled steroid use. 7. Patients who require potassium-wasting diuretics. 8. Patients who have received any investigational agent beyond those indicated for the treatment of prostate cancer within 5 half-lives of the agent; if the half-life of the agent is not known, the patients must be off investigational therapy for 4 weeks prior to enrollment (whichever is shorter of the two should be preferred). 9. Patients who have received palliative and other radiotherapy for the target lesion within 4 weeks of study enrollment. 10. Patients with symptomatic or known central nervous system metastases from prostate cancer or who are at high risk for spinal cord compression, per investigator's judgment. 11. Patients with a history of hypothalamus, pituitary or adrenal insufficiency. 12. Patients with >grade 2 neuropathy at study enrollment. 13. History of another primary malignancy that is currently clinically significant or currently requires active intervention. 14. Inadequately controlled hypertension (eg, systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg) or hypotension (eg, systolic blood pressure ≤ 80 mmHg or diastolic blood pressure ≤50 mmHg) after up to 3 measurements with at least 5 minutes apart during 28 days before study enrollment. 15. Patients with active cardiac disease or a history of cardiac dysfunction including any of the following:
  • Severe or unstable angina pectoris or acute coronary syndrome or stroke within 6 months prior to study enrollment.
  • Symptomatic pericarditis.
  • Documented myocardial infarction or arterial thrombotic events within 6 months prior to study enrollment.
  • History of documented congestive heart failure (New York Health Association functional classification III to IV).
  • Documented history of cardiomyopathy.
  • Known left ventricular ejection fraction <50% as determined by multiple gated acquisition scan or echocardiogram within 28 days prior to enrollment.
  • History of clinically significant cardiac arrhythmias unsuitable to participate, as determined by the investigator. 16. Patients with a Fridericia-corrected QT (QTcF) interval of >470 msec on the screening ECG (using the QTcF formula), has a short/long QT syndrome, or history of QT prolongation/Torsades de Pointes, unless prolonged QTc interval is due to (right or left) bundle branch block and/or pacemaker rhythm. If wide QRS complex is present, cardiology consultation is required to assess the risk for Torsade de Pointes. 17. Patients with a history of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 10 days before enrollment, including but not limited to tuberculosis. 18. Patients who have active human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infections. 19. Patients that are currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP1A (including but not limited: α-Naphthoflavone, Furafylline, Omeprazole, Lansoprazole) and isoenzyme CYP3A (including but not limited: Itraconazole, Ketoconazole, Azamulin, Troleandomycin, Verapamil, Rifampicin). The patients must have discontinued moderate or strong inducers for at least 2 weeks prior to study enrollment and must have discontinued moderate or strong inhibitors for at least 1 week before study enrollment. Spironolactone Strong bile salt export pump (BSEP) inhibitors, grapefruit juice, herbal medicines such as St. John's wort, Kava, ephedra, gingko biloba, dehydroepiandrosterone, yohimbe, saw palmetto and ginseng should be discontinued. 20. Sexually active males not willing to use a condom during the whole course of the study and for 16 weeks after stopping treatment. Male patients must not father a child in this period. A condom is required to be used also by vasectomized men as well as during intercourse with a male partner in order to prevent delivery of the drug via seminal fluid. 21. Patients with any other medical, psychiatric, or social condition, including substance abuse, which in the opinion of the investigator, would preclude participation in the study. 22. Patients with a history of upper gastrointestinal bleeding or uncontrolled peptic disease in the previous 3 months which in Investigator's opinion may impact patient's participation in the study. 23. Patients have previously received AKT or PI3 kinase pathway or mTOR inhibitors

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Clinical Validation of ClarityDX Prostate as a Reflex Test to Prostate Specific Antigen (PSA) to Refine the Prediction of Clinically-significant Prostate Cancer


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03957252

Sponsor: Nanostics

Phase:

Eligibility:

  • Age: minimum 40 Years maximum 75 Years
  • Gender: Male

Inclusion Criteria:

  1. Males between 40-75 years of age;
  2. With and without family history of prostate cancer;
  3. No prior prostate cancer diagnosis and who are referred to have a prostate biopsy;
  4. PSA (Roche Cobas) results >/= 3ng/mL and collected within 6m of enrollment;
  5. Willing to permit provincial agencies (e.g. Alberta Health Services, Alberta Health, Netcare, Service Alberta) to disclose health-related information to study;
  6. Undergoing a diagnostic prostate biopsy; and
  7. Provided informed consent to participate in the study.

Exclusion Criteria:

  1. Unwilling to participate in the study;
  2. Unavailable for biopsy procedure in recruitment areas;
  3. Not undergoing a prostate biopsy;
  4. Prior diagnosis of cancer excluding non-melanoma skin cancer; and/or
  5. Under the age of 40 years of age or over the age of 75 years of age.

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A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04100018

Sponsor: Bristol-Myers Squibb

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histologic confirmation of adenocarcinoma of the prostate without small cell features
  • Current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (CT/MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy
  • Documented prostate cancer progression per Prostate Cancer Working Group (PCWG3) criteria within 6 months prior to screening
  • Chemotherapy-naïve for metastatic castration-resistant prostate cancer (mCRPC), with 1 to 2 prior second generation hormonal therapies in the recurrent non-metastatic setting and/or metastatic setting, and no more than 1 second generation hormonal therapy in the mCRPC setting. Must have progressed during or after second generation hormonal therapy or have documented intolerance to second generation hormonal therapy
  • Participants must meet one of the following criteria regarding tissue submission: Sufficient tumor samples from a newly obtained ("fresh") biopsy (obtained during screening); or archival tumor tissue in the form of formalin-fixed paraffin-embedded (FFPE) block or unstained tumor tissue slides. For participants with bone-only disease or inaccessible soft tissue lesions or if the biopsy procedure would pose an unacceptable clinical risk for the participant, submission of tumor tissue obtained from a fresh biopsy is not required.
  • Men must agree to follow specific methods of contraception, if applicable Exclusion Criteria:
  • Active brain metastases
  • Active, known, or suspected autoimmune disease
  • Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel Other protocol-defined inclusion/

Exclusion Criteria:

  • Active brain metastases
  • Active, known, or suspected autoimmune disease
  • Condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids or adrenal replacement steroid doses are permitted in the absence of active autoimmune disease
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
  • Prior treatment with docetaxel or other chemotherapy for mCRPC. Prior docetaxel for metastatic castration-sensitive prostate cancer is permitted if at least 12 months have elapsed from last dose of docetaxel Other protocol-defined inclusion/exclusion criteria apply

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SAABR: Single Arm Phase II Study of AR Targeted Therapy + Atezolizumab + GnRH Analog and Stereotactic Body Radiotherapy (SBRT) to the Prostate in Men With Newly Diagnosed Hormone-sensitive Metastatic Prostate Cancer


Condition: Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04262154

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Willing and able to provide or have a legally authorized representative to provide written informed consent and HIPAA authorization for the release of personal health information. A signed informed consent must be obtained before screening procedures are performed. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
  • Males 18 years of age and above
  • Untreated metastatic (M1a/b/c) hormone-sensitive prostate cancer documented by positive bone scan or metastatic lesion on CT or MRI; untreated is defined as having never received surgical, radiotherapeutic, or systemic therapy to the prostate for cancer for their prostate cancer. Note, 10 subjects who have had prior hormonal therapy (GnRH analog +/- first-generation anti-androgen such a bicalutamide) started up to 3 months prior to signing consent to the trial will be permitted to enroll onto the study if they have demonstrated a decline in PSA. Anti-androgens must be stopped prior to Cycle 1. Note: patients who have started bicalutamide (Casodex) with or without a GnRH analog must stop prior to being registered on trial
  • Biopsy-proven adenocarcinoma of the prostate
  • Eligible for SBRT per institutional guidelines
  • ECOG status of 0 or 1
  • Normal organ function with acceptable initial laboratory values within 14 days of treatment start: ANC ≥ 1,500 /µl Lymphocyte count ≥ 0.5 x 109/L (500/µL) Albumin ≥ 3.5 g/dL Hemoglobin ≥ 9 g/dL Platelet count ≥ 100,000 /µl Creatinine within institutional normal limits Potassium ≥ 3.5 mmol/L(within institutional normal range) Bilirubin ≤1.5 x ULN Patients with known Gilbert disease: serum bilirubin ≤3 x ULN) SGOT(AST), SGPT ≥ 2.5 ULN with the following exceptions: (ALT), and AST and (ALT), and Alkaline Phosphatase (ALP) Patients with documented liver metastases: AST and ALT ≤ 5 x ULN; Patients with documented liver or bone metastases: ALP ≤ 5 x ULN INR ≤ 1.5 x ULN
  • Subjects must agree to use a medically acceptable method of birth control (e.g., spermicide in conjunction with a barrier such as a condom) or sexual abstinence for the duration of the study, including 150 days after the last dose of study drug. Sperm donation is prohibited during the study and for 30 days after the last dose of study drug. Female partners must use hormonal or barrier contraception unless postmenopausal or abstinent.

Exclusion Criteria:

  • History of malignancy within 3 years prior to initiation of study treatment, except for malignancies with a negligible risk of metastasis of dead (e.g., 5-year OS rate >90%), such as non-melanoma skin carcinoma
  • Pathological finding consistent with pure small cell carcinoma of the prostate
  • Prostate volume > 80 cc
  • Known or suspected brain metastasis or active leptomeningeal disease
  • Uncontrolled tumor-related pain. Patients requiring pain medication must be on a stable regimen at study entry. Symptomatic lesions (e.g. bone metastases causing nerve impingement) amenable to palliative radiotherapy should be treated prior to enrollment. Patient should be recovered from effects of radiation. There is no required minimum recovery period. Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g.,epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment).
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (one monthly or more frequently).
  • Uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic BP ≥95 mmHg). Subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
  • Positive HIV test at screening
  • Active hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test and/or HBV PCR at screening. Patients currently treated with anti-viral therapy for HBV. Subjects with a past or resolved HBV infection, defined as having a negative HBsAg and HBV PCR test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study.
  • Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at screening. The HCV RNA test will be performed only for subjects who have a positive HCV antibody test.
  • History of adrenal dysfunction
  • Uncontrolled or symptomatic hypercalcemia (ionized calcium >1.5 mmol/L, calcium > 12 mg/dL or corrected serum calcium > ULN)
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:
  • Subjects with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone
  • Subjects with controlled Type 1 diabetes mellitus who are on an insulin regimen
  • Subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., subjects with psoriatic arthritis are excluded) are allowed provided all the following conditions are met:
  • Rash must cover < 10% of body surface area
  • Disease is well controlled at baseline and requires only low-potency topical corticosteroids
  • No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Active tuberculosis
  • Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, cerebrovascular accident, unstable arrhythmia or unstable angina) within 6 months prior to initiation of study treatment
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Prior allogeneic stem cell or solid organ transplantation
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 [IL-2]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-a agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:
  • Subjects who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Sponsor Principal Investigator approval has been obtained.
  • Subjects who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation
  • Known allergy or hypersensitivity to any component of the abiraterone or prednisone formulations
  • Any other disease, metabolic dysfunction, physical examination finding, clinical laboratory finding or situation that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the subject at high risk from treatment complications

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Hypofractionated Radiosurgery for Localised Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03795337

Sponsor: University Hospital Schleswig-Holstein

Eligibility:

  • Age: minimum 60 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • non-metastatic, histopathologically confirmed prostate carcinoma cT 1-3 N0 M0
  • Gleason-grade ≤7
  • Guideline-based staging
  • Age ≥ 60 years
  • PSA < 15 ng / ml
  • Volume of the prostate < 80 cm³
  • IPSS-Score ≤ 12
  • Written informed consent

Exclusion Criteria:

  • Age ≤ 60 years
  • History of prior pelvic radiotherapy
  • Contraindication to MRI or Fiducial marker implantation (e.g. allergy to gold),
  • Immunosuppressive therapy
  • Relevant comorbidity thought to adversely affect treatment compliance,
  • Legal incapacity or lack of informed consent

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Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04263025

Sponsor: Hackensack Meridian Health

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum 30 Years maximum 70 Years
  • Gender: Male

Inclusion Criteria:

  1. Male aged between 30 and 70 years old
  2. Primary diagnosis of organ confined prostate cancer
  3. Scheduled to undergo bilateral, nerve-sparing RARP
  4. Patient has ICIQ-SF score <6
  5. Patient has no erectile dysfunction (defined as IIEF-6 score ≥ 26)
  6. Patient is willing to return for all visits as defined in the protocol
  7. Patient is willing to follow the instruction of the Investigator
  8. Patient has provided written informed consent

Exclusion Criteria:

  1. Previous history of pelvic radiation
  2. Previous history of simple prostatectomy or transurethral prostate surgery
  3. Previous history of systemic therapy for prostate cancer
  4. Patient has neurogenic bladder
  5. Body weight less than 50 kg (110 pounds) or a body mass index greater than 40 kg/m2
  6. History of open pelvic surgery within 5 years except for hernia repair
  7. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period.
  8. Any neurologic disorder or psychiatric disorder (e.g., Parkinson's Multiple Sclerosis, etc.) that might confound postsurgical assessments
  9. Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
  10. Previous history of anaphylaxis or hypersensitivity to liposomal amphotericin- B

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ProBio: An Outcome-adaptive and Randomized Multi-arm Biomarker Driven Study in Patients With Metastatic Prostate Cancer


Condition: Metastatic Castration-resistant Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03903835

Sponsor: Karolinska Institutet

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • Man with metastatic castrate resistant prostate cancer (histologically confirmed prostate adenocarcinoma) and castrate levels < 50 ng/dl of serum
  • Distant metastatic disease documented by positive bone scan or metastatic lesions on CT or MRI
  • Adequate health as assessed by the investigator to receive all available treatments in the trial
  • ECOG/WHO (Eastern Cooperative Oncology Group/ World Health Organization) performance score 0-2
  • Adequate organ and bone marrow function
  • Albumin greater than or equal to 28 umol/L
  • Able to understand the patient information and sign written informed consent

Exclusion Criteria:

  • Other malignancies within 5 years except non-melanoma skin cancer
  • Within 6 months of randomization: myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke, TIA (transient ischemic attack), or congestive heart failure NYHA (New York Heart Association) class III or IV
  • Uncontrolled hypertension
  • Received systemic therapy (with the exception of standard ADT) prior to study inclusion, for the CRPC indication
  • Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
  • Unable to comply with study procedures
  • Current participation in another clinical trial that will be in conflict with the present study, administration of an investigational therapeutic or invasive surgical procedure within 28 days prior to study enrolment
  • Patients who are unlikely to comply with the protocol
  • Any condition or situation which, in the opinion of the investigator, would put the subject at risk, may confound study results, or interfere with the subjects participation in this study.
  • Any medical condition that would make use of the study treatments contraindicated, according to the SmPC, e.g. significant heart or liver disease.

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An Extended/Phase 2, Multi-Center, Randomized, Open-Label Study to Evaluate the Safety and Tolerability of GT0918 in Subjects With Metastatic Castrate Resistant Prostate Cancer (mCRPC) Who Failed Either Abiraterone or Enzalutamide


Condition: Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03899467

Sponsor: Suzhou Kintor Pharmaceutical Inc,

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  1. Signed informed consent obtained prior to any study-related procedure being performed.
  2. Subjects at least 18 years of age or older at the time of consent.
  3. Subjects with histologically confirmed metastatic castrate resistant prostate cancer (mCRPC) who progressed after abiraterone or enzalutamide.
  4. Ongoing androgen deprivation therapy with a luteinizing hormone-releasing hormone (LHRH) "super-agonist" or antagonist, or bilateral orchiectomy and serum testosterone level < 50 ng/dL (< 0.5 ng/mL, < 1.7 nmol/L) at screening.
  5. Metastatic disease documented by computed tomography (CT)/magnetic resonance imaging (MRI) or bone scan.
  6. Progressive disease despite hormonal treatment with abiraterone or enzalutamide, but not both. However, if either of these 2 drugs was used less than 3 months due to toxicity, the patient is eligible. One line of chemotherapy is eligible. Progressive disease is defined by 1 or more of the following criteria:
  7. Subjects with a rising prostate specific antigen (PSA) value > 2 ng/mL in at least 2 measurements, at least 1 week apart. If the confirmatory PSA value is less than the screening PSA value, then an additional test for the rising PSA is required to document progression.
  8. Subjects with measurable disease, progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  9. Subjects with metastatic bone disease, progression defined by 2 or more new lesions in a radionuclide bone scan.
  10. ECOG performance status of 0-1
  11. Screening blood counts of the following:
  12. Absolute neutrophil count ≥ 1500/μL
  13. Platelets ≥ 100,000/μL
  14. Hemoglobin > 9 g/dL (if asymptomatic).
  15. Screening chemistry values of the following:
  16. Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 × upper limit of the normal reference range (ULN)
  17. Total bilirubin ≤ 2 × ULN
  18. Creatinine ≤ 1.5 × ULN
  19. Albumin > 2.8 g/dL.
  20. At screening, life expectancy of at least 6 months.
  21. Subjects whose partners are women of childbearing potential (WOCBP) must use an adequate method of birth control while on study drug and for at least 3 months after discontinuation of study drug.
  22. Subject is willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria:

  1. Discontinuation of enzalutamide or abiraterone less than 3 weeks prior to the start of study medication.
  2. Prior chemotherapy, radiation, sipuleucel-T or other experimental immunotherapy less than 3 weeks prior to the start of study medication
  3. Prior chemotherapies more than 1 line.
  4. Ongoing acute treatment-related toxicity associated with a previous therapy greater than grade 1 except for grade 2 alopecia or neuropathy.
  5. History of impaired adrenal gland function (e.g., Addison's disease, Cushing's syndrome).
  6. Known gastrointestinal disease or condition that affects the absorption of proxalutamide.
  7. History of congestive heart failure New York Heart Association (NYHA) class III or IV or uncontrolled hypertension at screening.
  8. History or family history of long QT syndrome, or ECG corrected QT interval equal to and over 500 ms (CTCAE grade 2) at baseline.
  9. History of other malignancy within the previous 3 years, except basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer.
  10. Use of systemic glucocorticoid (e.g., prednisone, dexamethasone) within 14 days prior to the start of study medication. Inhaled or topical steroids are allowed.
  11. Co-administration of CYP3A4 ligands that serve as substrates or induce or inhibit the enzyme (See Appendix 4 for the list of medications).
  12. Prior use of any herbal products known to decrease PSA levels (e.g., PC-SPES or saw palmetto) within 30 days prior to the start of study medication.
  13. Major surgery within 30 days prior to the start of study medication.
  14. Blood transfusion (including blood products) within 1 week of screening.
  15. Serious persistent infection within 14 days prior to the start of study medication.
  16. Serious concurrent medical condition including CNS disorders.
  17. Previous history of difficulty swallowing capsules.
  18. Known hypersensitivity to GT0918 or its excipients (See Appendix 5 for drug details).
  19. Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.

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A Phase I Trial of Enzalutamide Plus the Glucocorticoid Receptor Antagonist CORT-125134 (Relacorilant) for Patients With Metastatic Castration Resistant Prostate Cancer (CRPC)


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03674814

Sponsor: University of Chicago

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically or cytologically confirmed prostate cancer with documented metastatic disease 2. Evidence of castrate testosterone level <50ng/dl (or surgical castration) 3. Evidence of disease progression:
  • 2 or more new lesions on bone scan or
  • Progressive disease on CT/MRI according to Response Evaluation Criteria in Solid Tumors 1.1 criteria or
  • Rising Prostate Specific Antigen (PSA): PSA evidence for progressive prostate cancer consists of a minimum PSA level of at least 2 ng/ml, which has subsequently risen on at least 2 successive occasions, at least 2 weeks apart. 4. Prior treatment with at least one line of potent androgen receptor signaling inhibitor (e.g. abiraterone, enzalutamide, apalutamide) in either castration-sensitive or castration-resistant setting. 5. Any prior therapy for castrate disease is acceptable except prior GR antagonist treatment (e.g. mifepristone or relacorilant). 6. Any other radiotherapy or radionuclide require 28-day washout prior to first dose of study drug. 7. Denosumab or zoledronic acid are allowed. 8. ECOG performance status ≤ 2. 9. Patients must have normal hepatic function as defined below:
  • Total bilirubin
  • AST(SGOT)/ALT(SGPT)
  • Albumin >/=3.0 g/dL 10. Patients must have normal bone marrow function as defined below:
  • Platelet count (plt) >/= 80,000 /microliter
  • Hemoglobin (Hgb) >/= 9 g/dL
  • Absolute neutrophil count (ANC) >/= 1500 11. Patients must have normal renal function as defined below:
  • GFR >/= 30 mL/min 12. Ability to understand and the willingness to sign a written informed consent document. 13. Patients with active Diabetes Mellitus on glucose lowering medications are eligible provided they agree to and are able to self-monitor daily blood glucose levels due to potential risk of lowering glucose levels on relacorilant. 14. 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. Two acceptable methods of birth control thus include the following:
  • Condom (barrier method of contraception); AND
  • One of the following is required: 1. Established use of oral, or injected or implanted hormonal method of contraception by the female partner; 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; 3. Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner; 4. Tubal ligation in the female partner; 5. Vasectomy or other procedure resulting in infertility (e.g., bilateral orchiectomy), for more than 6 months.

Exclusion Criteria:

  1. Therapy with other hormonal therapy, including any dose of megestrol acetate (Megace), finasteride (Proscar), dutasteride (Avodart), or any herbal product known to decrease PSA levels (e.g., saw palmetto and PC-SPES), or any systemic corticosteroid within 2 weeks prior to first dose of study drug. a.Patients who have been on systemic corticosteroids with prednisone equivalent of 10mg or greater for greater than 3 months immediately prior to participation in this study must have documented ability to tolerate cessation of corticosteroids prior to enrollment.
  2. Inability to swallow capsules or known gastrointestinal malabsorption.
  3. Evidence of visceral disease on imaging in a patient who is an appropriate candidate for cytotoxic chemotherapy (docetaxel or cabazitaxel).
  4. History of other malignancies, with the exception of: adequately treated non-melanoma skin cancer, adequately treated superficial bladder cancer, stage 1 or 2 malignancies who are without evidence of disease, or other cancers curatively treated with no evidence of disease for > 5 years from enrollment.
  5. Blood pressure that is not controlled despite > 2 oral agents (SBP >160 and DBP >90 documented during the screening period with no subsequent blood pressure readings >160/100).
  6. History of seizure disorder or active use of anticonvulsants. Medications used to treat neuropathic pain such as gabapentin or pregabalin are allowed.
  7. Documented history of or current brain metastases due to seizure risk
  8. Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled.
  9. Active psychiatric illness/social situations that would limit compliance with protocol requirements.
  10. NYHA class II, NYHA class III, or IV congestive heart failure (any symptomatic heart failure).
  11. Concurrent therapy with strong inhibitors or inducers of CYP3A4 or CYP2C8 (See Section 9.12below for list of strong inhibitor or inducers) due to concerning possible drug-drug interactions
  12. Presence of concurrent medical conditions requiring systemic glucocorticoids for immunosuppression (e.g. Autoimmune diseases, organ transplantation) that is active and has required glucocorticoids in the last 6 months.

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