Prostate Cancer

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Randomized Phase IB/II Study of Enzalutamide With and Without Ribociclib in Patients With Metastatic Castrate Resistant, Chemotherapy Naïve Prostate Cancer That Retains RB Expression


Condition: Hormone-Resistant Prostate Cancer, Metastatic Prostate Carcinoma, Prostate Carcinoma Metastatic in the Bone, Stage IV Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02555189

Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information. NOTE: HIPAA authorization may be either included in the informed consent or obtained separately. Consent and HIPPA authorization must be obtained prior to any screening procedures. 2. Males 18 years of age and above 3. Histological or cytological proof of prostate cancer 4. Documented progressive mCRPC based on at least one of the following criteria:
  • PSA progression defined as 25% increase over baseline value with an increase in the absolute value of at least 2 ng/mL that is confirmed by another PSA level with a minimum of a 1 week interval and a minimum PSA of 2 ng/mL.
  • Soft-tissue progression defined as an increase ≥ 20% in the sum of the LD of all target lesions based on the smallest sum LD since treatment started or the appearance of one or more new lesions.
  • Progression of bone disease (evaluable disease) or (new bone lesion(s)) by bone scan. 7) Have testosterone < 50 ng/dL. Patients must continue primary androgen deprivation with an LHRH analogue (agonist or antagonist) if they have not undergone orchiectomy 8) ECOG performance status of 0-1 9) Patients on long term (>6 months) anti-androgen therapy (e.g., flutamide, bicalutamide, nilutamide) will need to be off anti-androgen for 4 weeks (wash out period) and show evidence of disease progression off the anti-androgen. Patients that have been on an anti-androgen 6 months or less will need to discontinue anti-androgen therapy prior to enrollment (no wash out period required). 10) Patient has adequate bone marrow and organ function as defined by the following laboratory values:
  • Absolute neutrophil count ≥ 1.5 × 109/L.
  • Platelets (UNVPLT) ≥ 100 × 109/L.
  • Hemoglobin (HGB) ≥ 9 g/dl.
  • Potassium (K), total calcium (CA)(corrected for serum albumin), magnesium, sodium (NA) and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication.
  • INR ≤ 1.5.
  • Serum creatinine (CREAT) ≤ 1.5 mg/dL or creatine clearance > 50 mL/min.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN. If the patient has liver metastases, ALT and AST must still be ≤ 2.5 x ULN. Patients with liver metastases and AST/ALT above this limit will not be enrolled..
  • Total serum bilirubin ≤ 1.5 x ULN; or total bilirubin (TBILI) ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert's Syndrome. 11) The effects of ribociclib on the developing human fetus at the recommended therapeutic dose are unknown. Men must agree to use adequate contraception prior to enrollment, for the duration of study participation and for at least 3 months thereafter. 12) Must be able to take oral medication without crushing, dissolving or chewing tablets.

Exclusion Criteria:

  • 1. Prior exposure to abiraterone acetate or other specific CYP-17 inhibitors. Abiraterone acetate given in the castration-sensitive setting is permissible if stopped at least 6 months prior to initial protocol treatment. 2. Prior exposure to enzalutamide or other investigational AR directed therapy 3. Prior chemotherapy. 4. Prior isotope therapy with strontium-89, samarium or radium-223 within 12 weeks of enrollment. 5. Administration of antifungal agents (itraconazole, fluconazole, etc) within 4 weeks of enrollment or unrecovered AEs due to agents administered more than 4 weeks of enrollment. 6. History of pituitary or adrenal dysfunction, active or symptomatic viral hepatitis or chronic liver disease. 7. Known symptomatic brain metastases. 8. Use of any prohibited concomitant medications: immunotherapy, 5 alpha reductase inhibitors, spironolactone, diethylstilbestrol (DES), ketoconazole, newer medications targeting ARs. NOTE: Because of the potential for drug-drug interaction, the concurrent use of all other drugs, over-the-counter medications, or alternative therapies must be documented. The principal investigator should be alerted if the patient is taking any agent that interacts with CYP450 system. 9. Treatment-related toxicity from prior therapy > Grade 2. 10. Peripheral neuropathy > 2 11. History of hypersensitivity to ribociclib or compounds of similar chemical or biologic composition to ribociclib including to peanut and soy or other drugs formulated with polysorbate 80; or enzalutamide. All herbal, alternative and food supplements (i.e., PC-Spes, Saw Palmetto, St John Wort, etc.). They must be discontinued prior to enrollment. Patients may continue on a daily Multi-Vitamin, calcium and Vitamin D. 12. Planned surgery or radiation therapy during protocol treatment, 13. Hormonal-acting agents (including DES, aldosterone, and spironolactone but not including GnRH agonists or antagonists) are forbidden during the trial and must be stopped prior to enrollment. No washout period will be required for any of these agents. 14. Initiation of bisphosphonate/denosumab therapy during protocol treatment. Patients on stable doses of bisphosphonates or denosumab which have been started no less than 4 weeks prior to enrollment may continue on this medication. NOTE: Initiation of bisphosphonate/denosumab therapy will be allowed for the treatment of osteoporosis or prevention of skeletal-related events (SRE) during protocol treatment. 15. Patient has a concurrent malignancy or malignancy within 3 years of enrollment, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer. 16. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection). 17. Patient has a known history of HIV infection (testing not mandatory). 18. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). 19. Patient has clinically significant, uncontrolled heart disease and/or recent events including any of the following:
  • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to enrollment
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV)
  • Documented cardiomyopathy
  • Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening
  • History of any cardiac arrhythmias, eg., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality within 12 months prior to enrollment.
  • Family history of QTc prolongation or of unexplainable sudden death at <50 years of age.
  • On screening 12 lead ECG, any of the following cardiac parameters: bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec. Congenital long QT syndrome or family history of long QT syndrome.
  • Systolic blood pressure (SBP) >160 mmHg or <90 mmHg.
  • Bradycardia (heart rate < 50 at rest), by ECG or pulse, at screening 20. On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF >450 msec (using Fridericia's correction). All as determined by screening ECG (mean of triplicate ECGs) 21. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to enrollment:
  • Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges.
  • That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
  • That have a known risk to prolong the QT interval or induce Torsades de Pointes.
  • Herbal preparations/medications, dietary supplements 22. Patient is currently receiving or has received systemic corticosteroids within <2 weeks prior to enrollment, or who have not fully recovered from side effects of such treatment.
  • The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular) 23. Patient is currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed. 24. Patient who has participated in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer. 25. Patient who has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to enrollment, and who has not recovered to Grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom ≥ 30% of the bone marrow was irradiated. 26. Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
  • At least 4 weeks from prior therapy completion (including radiation and/or surgery) to enrollment
  • Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases 27. Patient has had major surgery within 14 days prior to enrollment or has not recovered from major side effects (tumor biopsy is not considered as major surgery). 28. Patient has not recovered from all toxicities related to prior anticancer therapies to NCI-CTCAE version 4.03 Grade <1 (Exception to this criterion: patients with any grade of alopecia are allowed to enter the study). 29. Patient with a Child-Pugh score B or C. 30. Patient has a history of non-compliance to medical regimen or inability to grant consent. 31. Sexually active males unless they use a condom during intercourse while taking the drug and for 30 days after stopping treatment and should not father a child in this period. A condom is required to be used by vasectomized men in order to prevent delivery of the drug via seminal fluid.

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A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03706365

Sponsor: Eli Lilly and Company

Phase: Phase 2/Phase 3

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate.
  • Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI).
  • Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following:
  • PSA progression
  • Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression
  • Have adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Exclusion Criteria:

  • Prior therapy with cytochrome P450 (CYP)17 inhibitors.
  • Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6 inhibitors.
  • Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer [mHSPC] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions.
  • Currently enrolled in a clinical study involving an investigational product.
  • Gastrointestinal disorder affecting the absorption or ability to swallow large pills.
  • Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).

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Imaging of the Prostate Gland Using High Field Strength 3T MRI


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01653093

Sponsor: Ohio State University Comprehensive Cancer Center

Eligibility:

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

Inclusion Criteria:

  • Patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (Gleason's score >= 7 and prostate-specific antigen [PSA] of > 10ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians
  • Written informed consent will be signed by the patients before the MRI based on the guidelines approved by the Ohio State University Institutional Review board
  • Patients must have an estimated glomerular filtration rate of >= 30 mL/min/1.73m^2 within six weeks of the MRI to be included in the study

Exclusion Criteria:

  • Patients with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)
  • Patients with any type of ferromagnetic bioimplant that could potentially be displaced or damaged
  • Patients that have vascular or aneurysm clips, or metallic staples from a surgical procedure
  • Patients with permanent tattoo eye liner (may contain metallic coloring)
  • Patients that may have shrapnel imbedded in their bodies, such as from war wounds, metal workers and machinists (metallic fragments in or near eyes), severe auto accident victims
  • Patients that exhibit noticeable anxiety and/or claustrophobia
  • Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher
  • Patients who have cardiac or known circulatory impairment, and/or the inability to perspire (poor thermoregulatory function)
  • Patients with an estimated glomerular filtration rate of < 30 mL/min/1.73m^2 within six weeks of the MRI
  • Acute or chronic severe renal insufficiency (estimated glomerular filtration rate < 30 mL/min/1.73m^2)
  • Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period

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IMPACT: Immunotherapy in Patients With Metastatic Cancers and CDK12 Mutations


Condition: Metastatic Castration Resistant Prostate Cancer, Metastatic Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03570619

Sponsor: University of Michigan Rogel Cancer Center

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Be ≥18 years of age as of date of signing informed consent.
  • Be willing and able to provide written informed consent for the study.
  • ECOG Performance Status of 0, 1 or 2 (Eastern Cooperative Oncology Group scoring system used to quantify general well-being and activities of daily life; scores range from 0 to 5 where 0 represents perfect health and 5 represents death.
  • Subjects must have a histologic or cytologic diagnosis of metastatic adenocarcinoma of the prostate without small cell histology OR another type of metastatic carcinoma.
  • All subjects, regardless of cancer type, must have a documented CDK12 aberration in tumor tissue.
  • Subjects with prostate cancer must have documented prostate cancer progression within six months prior to screening with PSA progression defined as a minimum of three rising PSA levels ≥ 1; 1 week between each assessment with a baseline PSA value at screening of ≥ 2 ng/mL.
  • Subjects with prostate cancer must have ongoing androgen deprivation with total serum testosterone < 50 ng/dL (or ≤ 0.50 ng/mL or 1.73 nmol/L)). If the subject is currently being treated with LHRH agonists (subjects who have not undergone an orchiectomy), this therapy must have been initiated at least 4 weeks prior to registration. This treatment must be continued throughout the study.
  • Subjects with non-prostate histologies must have RECIST 1.1-measurable cancer on computed tomography (CT) or magnetic resonance imaging (MRI) scans.
  • Subjects must have recovered to baseline or ≤ grade 1 toxicities related to any prior treatments unless AE(s) are clinically non-significant and/or stable.
  • Patients must be ≥ 2 weeks from most recent systemic therapy or most recent radiation therapy.
  • Women of childbearing potential must have a negative serum or urine pregnancy test within 28 days prior to registration.
  • Female and male subjects of reproductive potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 5 months (for women) and 7 months (for men) after the last dose of study therapy.
  • Adequate organ and marrow function

Exclusion Criteria:

  • Prior treatment with anti-PD-1/PD-L1 and anti-CTLA-4 is NOT allowed. Prior intravesical BCG therapy is allowed.
  • Treatment with any investigational agent or on an interventional clinical trial within 28 days prior to registration.
  • Prior or concurrent malignancy except for: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, localized or locally advanced prostate cancer definitively treated without recurrence or with biochemical recurrence only, or any other cancer fully treated or from which the subject has been disease-free for at least 2 years.
  • Autoimmune diseases such as rheumatoid arthritis. Vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed.
  • Need for systemic corticosteroids >10mg prednisone daily or equivalent alternative steroid (except physiologic dose for adrenal replacement therapy) or other immunosuppressive agents (such as cyclosporine or methotrexate) Topical and inhaled corticosteroids are allowed if medically needed.
  • Any history of organ allografts
  • Any history of HIV, hepatitis B or hepatitis C infection

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Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03436654

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 written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
  • Male aged 18 years and above
  • Serum testosterone of ≥150 ng/dL (For Cohorts A and B1, testosterone level requirement is exempted if they are already on ADT prior to treatment start. For Cohort B2, subjects will be considered eligible if their testosterone is currently ≥150 ng/dl).
  • Histologically confirmed adenocarcinoma of the prostate, who meet the following criteria: Cohort A
  • Clinically localized disease with histologically confirmed adenocarcinoma of the prostate with either ≥3 positive cores or 2 positive cores if >1cm in length with at least 50% tumor content WITH
  • With Gleason score 8-10 OR
  • Gleason 4+3 with one of the following features:
  • PSA ≥ 20 mg/mL within 2 months prior to diagnostic biopsy
  • MRI suspicious for radiographic ≥T3 disease (if urologist deems tumor is resectable at baseline); defined as >75% probability of extracapsular extension or seminal vesicle invasion in the opinion of the reading radiologist. OR
  • Gleason 3+4 or 4+3 and Oncotype DX Genomic Prostate Score of >40
  • With or without clinical N1 (size >1.5cm in the short axis) (Gleason score requirement can be omitted if node positive) OR Cohort B1
  • Newly diagnosed low-volume metastatic disease with either.
  • Bone metastases as documented by CT, MRI or radionuclide bone scan amenable to treatment with a maximum of 3 radiation isocenters* These lesions must have a structural correlate on CT or MRI to allow for adequate radiation targeting *(note:subjects with PET scans that show osseous metastases that would not be amenable to 3-isocenter radiation treatment are still eligible if conventional imaging shows osseous disease that can be treated with 3 radiation isocenters) And/or
  • Retroperitoneal nodes up to the level of the renal hilum with/without pelvic nodal metastasis >1.5cm in the short axis OR Cohort B2 (Cohort B2 expansion)
  • Biochemically persistent/recurrent disease (defined as PSA >0.2) after RP ± extended pelvic nodal dissection identified on PSMAb PET scans
  • PSMA PET evidence of M1a/M1b disease that could be covered in up to 3 radiation plans (note that the isocenter for planned prostate bed/pelvic nodal irradiation does not count towards the 3 isocenter limit)
  • No radiographic evidence of local or regional recurrence on imaging in subjects with prior salvage radiation to these areas.
  • Prior salvage radiotherapy is permitted. Prior metastasis-directed radiation is not permitted.
  • Castration sensitive disease
  • Multiple lesions within one isocenter may be permitted upon review by the sponsor's radiation oncologist
  • ECOG performance status of ≤ 1
  • Adequate bone marrow, hepatic and renal function, as evidenced within 28 days prior to treatment start by:
  • ANC ≥ 1500/µl
  • Hemoglobin ≥ 9g/dL
  • Platelet count ≥ 100,000/µl
  • Serum Creatinine GFR ≥30 mL/min
  • Porassium within institutional normal range
  • Total Bilirubin ≤ 1.5 x ULN (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible)
  • Albumin ≥ 3.0 g/dL
  • SGOT (AST) ≤ 2.5 x ULN
  • SGPT (ALT) ≤ 2.5 x ULN
  • Subjects must have a clinical T stage documented by the treating urologist/medical oncologist within 90 days prior to treatment start using the 7th edition AJCC staging system, recorded as the urologist's/medical oncologist's best clinical assessment of extent of local disease by digital rectal examination and/or available imaging studies such as transrectral ultrasound, CT scan, and/or MRI. Applicable to Cohort A and B1.
  • The primary tumor must be considered unresectable by RP based on initial imaging with gross negative margins as determined by a urologist and documented as such. (applicable to Cohorts A and B1 only)
  • Recovery of reversible effects of prior surgery (i.e., incisional pain, wound drainage) to Grade ≤1, and at least 4 weeks from prior surgery to treatment start. (biopsy excluded)
  • Able to swallow the study drug(s) whole as a tablet
  • Willing to take abiraterone acetate on an empty stomach; no food should be consumed at least one hour before and for at least two hours after the dose of abiraterone acetate is taken (Note: apalutamide does not have to be taken on an empty stomach.)
  • Agrees to use a condom (even men with vasectomies) and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug.
  • For Cohorts B1 and B2 only, biopsy confirmation of metastases (strongly encouraged; if safe and feasible at treating center)

Exclusion Criteria:

  • Prior treatment for prostate cancer including prior surgery (excluding TURP and subjects with rising PSA after RP), pelvic lymph node dissection, radiation therapy unless the subject is eligible for Cohort B2.
  • Prior cytotoxic chemotherapy or biologic therapy for prostate cancer
  • Up to 2 months of prior ADT with GnRH antagonist/agonist at time of treatment start. Bicalutamide given for ≤ 12 months at the time of registration as flare prevention is allowed. For Cohort B2, prior ADT and/or first generation anti-androgen treatment in the (neo)adjuvant and/or salvage setting in conjunction with radiation or surgery is allowed provided last effective dose of ADT and/or first generation anti-androgen is > 12 months prior to the on treatment date and total duration of prior therapy is 12 months or lesser, and their testosterone is currently >150ng/dL.
  • Prior exposure to ketoconazole (systemic), abiraterone acetate, enzalutamide or other agents targeting the AR signaling pathway
  • Concomitant therapy with any other experimental drug
  • Known brain, liver, lung or other visceral metastasis (except for retroperitoneal and / or pelvic nodal metastases as per inclusion criteria)
  • Prior prostate cancer metastasis-directed therapies
  • Currently active second malignancy or past history of malignancies diagnosed within the last 2 years that require active therapy and/or in remission with life expectancy of < 5 years, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, state I head and neck cancer, or stage I colorectal cancer
  • Significant medical condition other than cancer, that would prevent consistent and compliant participation in the study that would, in the opinion of the investigator, make this protocol unreasonably hazardous including but not limited to:
  • Any medical condition requiring a higher dose of corticosteroid than 10mg prednisone/prednisolone once daily
  • Active infection requiring systemic therapy
  • History of gastrointestinal disordered (medical disorders or extensive surgery) that may interfere with the absorption of the study agents
  • Uncontrolled hypertension (systolic BP ≥ 160 mmHg or diastolic BP ≥ 95 mmHg); subjects with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment (systolic BP < 160 mmHg or diastolic BP <95 mmHg)
  • Active or symptomatic viral hepatitis of chronic liver disease
  • Acute or chronic hepatitis B or hepatitis C infection. (Hepatitis B and C testing are not mandatory)
  • Presence of hepatitis B surface antibody is acceptable Human immunodeficiency virus (HIV)-positive subjects with 1 or more of the following: Not receiving highly active anti-retroviral therapy. A change in anti-retroviral therapy within 6 months of the start of screening (except if, after consultation with the principal investigator (PI) / sponsor, a change is made to avoid a potential drug-drug interaction with the study drug). Receiving anti-retroviral therapy that may interfere with the study drug(s) (consult the PI / sponsor for review of medication prior to enrollment). CD4 count < 350 cell/mm^3 at screening. An acquired immunodeficiency syndrome-defining opportunistic infection within 6 months of the start of screening.
  • History of pituitary or adrenal dysfunction
  • History of hypogonadism
  • Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class III or IV heart disease or cardiac ejection fraction measurement of <50% at baseline, or clinically significant ventricular arrhythmias within 6 months prior to treatment start.
  • History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness
  • Uncontrolled diabetes mellitus
  • History of inflammatory bowel disease
  • Baseline moderate and severe hepatic impairment (Child Pugh Class B & C)
  • Use of any prohibited concomitant medications within 14 days prior to treatment start, or use of prohibited concomitant medication listed in section 7.9.1 within the outlined windows NOTE: Medications known to lower the seizure threshold must be discontinued or substituted at least 4 weeks prior to treatment start
  • Pre-existing condition that warrants long-term corticosteroid use in excess of 10 mg prednisone/prednisolone daily
  • Known allergies, hypersensitivity or intolerance to apalutamide, abiraterone acetate, prednisone, or GBRH agonist or GNRH antagonist
  • Administration of an investigational therapeutic within 30 days of treatment start
  • Patients that cannot tolerate MRI
  • Any condition which, in the opinion of the investigator, would preclude participation in this trial

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Biomarker Study to Determine Frequency of DNA-repair Defects in Men With Metastatic Prostate Cancer


Condition: Metastatic Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03871816

Sponsor: Janssen Research & Development, LLC

Phase:

Eligibility:

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

Inclusion Criteria:

  • Diagnosis of metastatic (Stage IV) prostate cancer (PC), confirmed by either biopsy of a metastatic tumor site or history of localized disease supported by metastatic disease on imaging studies (that is [i.e.], clearly noted in hospital/clinical records)
  • Signed Informed consent form (ICF)
  • No condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (for example [e.g.], compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Willing to provide a saliva, blood, and/or archival tumor tissue sample for genomic analysis
  • No prior poly (adenosine diphosphate [ADP]-ribose) polymerase inhibitor (PARPi) for the treatment of prostate cancer
  • No prior DNA-repair gene defect test results from a Janssen sponsored interventional trial

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177Lu-PSMA-617 Therapy and Olaparib in Patients With Metastatic Castration Resistant Prostate Cancer


Condition: Metastatic Castration Resistant Prostate Cancer (mCRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03874884

Sponsor: Peter MacCallum Cancer Centre, Australia

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Patients must meet all of the following criteria for study entry: 1. Patient must be ≥ 18 years of age and must have provided written informed consent. 2. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell differentiation. 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (see Appendix 1). 4. Patients must have had at least one prior line of taxane (docetaxel) chemotherapy either in the hormone sensitive or castrate resistant setting unless the patient is deemed medically unsuitable for chemotherapy. If a patient has had docetaxel chemotherapy twice, this will be considered one line. 5. Patients must have progressed on a second generation AR targeted agent (e.g. enzalutamide, abiraterone and/or apalutamide). Determination of disease progression on second generation AR targeted agent will be made by the local investigator. 6. Patients must have progressive disease for study entry. This is defined by PCWG3 as any one of the following:
  • PSA progression: minimum of two rising PSA values from a baseline measurement with an interval of ≥ 1 week between each measurement. The PSA value at screening should be ≥ 10ng/ml.
  • Soft tissue or visceral disease progression as per RECIST 1.1 criteria (see Appendix 2)
  • Bone progression: ≥ 2 new lesions on bone scan (Appendix 2) 7. At least 3 weeks since the completion of surgery or radiotherapy prior to registration. Any clinically relevant sequelae from the surgery or radiotherapy must have improved to grade 1 prior to registration. 8. Prior surgical orchiectomy or chemical castration maintained on luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist). Patients without prior surgical castration must be currently taking and willing to continue luteinizing hormone-releasing hormone (LHRH) analogue (agonist or antagonist) therapy throughout the duration of study treatment. 9. Serum testosterone levels ≤ 50ng/dL (≤ 1.75nmol/L) within 28 days before registration. 10. Imaging evidence of metastatic disease documented with either bone scan or CT scan (Appendix 2). 11. Prior prostate cancer vaccine therapy, radiation therapy, systemic therapies, diethylstilboestrol (DES) or other estrogens, bicalutamide, flutamide or nilutamide are allowed up to 28 days prior to trial registration. Note: bicalutamide, flutamide or nilutamide must be discontinued within 4 weeks of registration. 12. Significant PSMA avidity on 68Ga/18F-PSMA PET/CT, defined as a minimum uptake of SUVmax 15 at a site of disease, and SUVmax > 10 at other sites of disease ≥10mm (unless subject to factors explaining a lower uptake, e.g. respiratory motion, reconstruction artefact). 13. Patients must have a life expectancy ≥ 24 weeks. 14. Patients must use a condom during treatment and for 3 months after the last dose of olaparib when having sexual intercourse with a pregnant woman or with a woman of childbearing potential. Female partners of male patients should also use a highly effective form of contraception (see section 11.7.4 for acceptable methods). 15. Patients must be willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled assessments including completing Patient Reported Outcomes (PRO) instruments. 16. Patients must have adequate bone marrow, hepatic and renal function documented within 28 days prior to registration, defined as:
  • Haemoglobin ≥ 100 g/L independent of transfusions (no red blood cell transfusion in last 8 weeks)
  • Absolute neutrophil count ≥ 1.5x109/L
  • Platelets ≥ 150 x109/L
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) except for patients with known Gilbert's syndrome where this applies for the unconjugated bilirubin.
  • Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤ 2.5 x ULN if there is no evidence of liver metastasis or ≤ 5 x ULN in the presence of liver metastases.
  • Albumin ≥ 30 g/L
  • Adequate renal function: patients must have creatinine clearance estimated of ≥ 51 mL/min using the Cockcroft-Gault equation or based on a 24 hour urine test to appendix 5). 17. Patients who are deemed by PSMA imaging to have readily accessible disease will be required to consent to 3 serial tumour biopsies
  • at screening, post combination treatment (at any time between weeks 2-4) and in the event of disease progression.

Exclusion Criteria:

  • Patients must not meet any of the following criteria for study entry: 1. Site(s) of disease that are FDG positive with low PSMA expression defined by PSMA SUVmax < 10. 2. Extensive marrow disease defined by a "Super Scan" on bone scintigraphy or diffuse marrow infiltration on PSMA PET. 3. Previous history or presence of brain metastases or leptomeningeal metastases. A scan to confirm the absence of brain metastases is not required if there is no clinical history of this. 4. Surgery or radiotherapy within < 3 weeks of registration (except for palliative reasons). Patients must have recovered from any effects of any major surgery. 5. Patients with symptomatic or impending cord compression unless appropriately treated beforehand and clinically stable for ≥ 4 weeks. 6. Any prior exposure to 177Lu-PSMA, cabazitaxel, platinums, PARP inhibitors, mitoxantrone or cyclophosphamide. 7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or psychiatric illness/social situations that is likely to impede participation and /or compliance in the study. 8. Persistent toxicities [Common Terminology Criteria for Adverse Event (CTCAE) ≥ grade 2] caused by previous cancer therapy, excluding alopecia. 9. Other malignancies within the previous 2-years other than basal cell or squamous cell carcinomas of skin or other cancers that are unlikely to recur within 24 months. 10. Previous history of interstitial lung disease or non-infectious pneumonitis. 11. Patients with a history or clinical features suggestive of myelodysplastic syndrome / acute myeloid leukaemia. 12. Patients unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with the absorption of the study medication. 13. Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTcF prolongation > 500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome. 14. Known hypersensitivity to olaparib or any of the excipients of olaparib. 15. Immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV1/2). Only need to check this if there is a clinical history. HIV-infected (HIV1/2 antibody-positive) patients may participate if they meet all the following eligibility requirements:
  • They must be on an anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on this same regimen; the most recent undetectable viral load must be within the past 12 weeks.
  • They must have a CD4 count ≥ 250 cells/µL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/µl over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy-induced bone marrow suppression.
  • For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/µl during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy.
  • They must have an undetectable viral load and a CD4 count ≥ 250 cells/µL within 7 days of enrolment.
  • They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months. 16. Patients with known active hepatitis (i.e. Hepatitis B or C). Only need to check this if there is a clinical history.
  • Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible.
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 17. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting olaparib is 2 weeks. 18. Concomitant use of known strong (e.g. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting olaparib is 5 weeks for phenobarbital and enzalutamide and 3 weeks for other agents. 19. Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT). 20. Participation in another clinical study with an investigational product or another systemic therapy administered in the last 3 weeks.

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A Phase 1/2 Study of Combination Olaparib and Radium-223 in Men With Metastatic Castration-Resistant Prostate Cancer With Bone Metastases (COMRADE)


Condition: Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03317392

Sponsor: National Cancer Institute (NCI)

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate
  • Participants must have castrate levels of serum testosterone < 50 ng/dL
  • Participants without orchiectomy must be maintained on luteinizing hormone releasing hormone (LHRH) agonist/antagonist; participants receiving prior docetaxel abiraterone, or next generation AR antagonist (enzalutamide, apalutamide, or darolutamide) for hormone sensitive disease are permitted
  • Participants must have progressive disease as defined by any of the following:
  • Castrate resistant disease as defined by PCWG-3 criteria; participants must have a rise in PSA on two successive determination at least one week apart and PSA levels >= 2 ng/mL (only the screening PS needs to be >= 2 ng/mL) and serum testosterone < 50 ng/dL
  • Soft tissue progression as defined by RECIST version 1.1
  • Bone disease progression as defined by PCWG-3 criteria including the development of two or more new lesions on bone scan
  • Participants must have >= 2 bone metastases by radiographic imaging and at least 1 lesion which has not been treated with prior radiation therapy
  • Participants must have tumor accessible for biopsy and be agreeable to baseline tumor biopsy; a metastatic focus is preferred but if not available and prostate is still intact prostate biopsy can be performed
  • Availability at the study site of formalin-fixed, paraffin-embedded (FFPE) archival tumor specimens, when available
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 80%)
  • White blood cell count (WBC) >= 3,000/mcL (within 28 days prior to administration of study treatment)
  • Absolute neutrophil count (ANC) >= 1,500/mcL (within 28 days prior to administration of study treatment)
  • Platelets >= 100,000/mcL (within 28 days prior to administration of study treatment)
  • Hemoglobin >= 10 g/dL (transfusions permitted) (within 28 days prior to administration of study treatment)
  • Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN) (within 28 days prior to administration of study treatment); for subjects with Gilbert's disease =< 3.0 mg/dL
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional ULN (within 28 days prior to administration of study treatment)
  • Creatinine clearance >= 51 ml/min as defined by Cockcroft-Gault equation (within 28 days prior to administration of study treatment)
  • Participants should be receiving an osteoclast targeting agent including either bisphosphonates or denosumab except in patients with contraindications as determined by the treating investigator including:
  • Hypocalcemia
  • Hypophosphatemia
  • Renal impairment including those with a glomerular filtration rate < 35 mL/min using the Cockcroft-Gault equation
  • Hypersensitivity to drug formulation
  • Dental condition or need for dental intervention that per the investigator would increase the risk of osteonecrosis of the jaw
  • The effects of olaparib and radium-223 on the developing human fetus are unknown; for this reason, men treated or enrolled on this protocol must agree to use adequate contraception and avoid sperm donation prior to the study, for the duration of study participation, and three months after discontinuation of olaparib and radium-223 administration
  • Human immunodeficiency virus (HIV)-positive with negative viral loads on stable antiretroviral regimen and CD4 count > 250 are eligible
  • Ability to understand and the willingness to sign a written informed consent document; patients with impaired decision-making who have a legal guardian (e.g., spouse) able to make informed decisions on behalf of the patient are eligible
  • Patients must be able to tolerate oral medications by mouth and not have a gastrointestinal illness that would preclude absorption of olaparib

Exclusion Criteria:

  • Pathology consistent with small cell carcinoma of the prostate
  • Presence of visceral metastases (liver, lung, brain, etc.) or malignant lymphadenopathy exceeding 4 centimeters (cm) in short diameter
  • Prior treatment with radium-223
  • Prior treatment with olaparib or other PARPi
  • Treatment with abiraterone, apalutamide, or darolutamide within 2 weeks of treatment initiation; treatment with cytotoxic chemotherapy within 3 weeks of treatment initiation; treatment with investigational prostate cancer directed therapy within 4 weeks of treatment initiation; treatment with enzalutamide within 4 weeks of treatment initiation
  • Prior hemibody external radiotherapy
  • Palliative radiation therapy to the bone or other sites within 2 weeks of treatment initiation
  • Participants who are receiving any other investigational agents
  • Imminent or established spinal cord compression based on clinical and/or imaging findings
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring need for intravenous anti-microbials, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Clinically significant medical condition defined as:
  • Cerebral infarction within 6 months of study treatment
  • Transient ischemic attack within 3 months of study treatment
  • Myocardial infarction within 6 months of study treatment
  • Uncontrolled angina within 3 months of study treatment
  • Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or subjects with history of congestive heart failure NYHA class 3 or 4 in the past, or history of anthracycline or anthracenedione (mitoxantrone) treatment, unless a screening echocardiogram or multi-gated acquisition scan performed within 3 months of the screening visit results in a left ventricular ejection fraction that is >= 45%
  • History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsade de pointes)
  • Prolonged corrected QT interval by the Fridericia correction formula on the screening electrocardiogram (ECG) > 470 msec (as determined on 2 or more time points within a 24 hour period if the first ECG demonstrates a prolonged corrected QT interval) or family history of long QT syndrome
  • History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place
  • Uncontrolled hypertension as indicated by a resting systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg at the screening visit
  • History of hypertensive emergency or encephalopathy within 6 months of study treatment
  • Deep venous thrombosis or pulmonary embolism within 3 months of study treatment
  • Major surgery within 4 weeks of study treatment; subjects with clinically relevant ongoing complications from prior surgery are not eligible
  • History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
  • Patient unable to swallow orally administered medication
  • History of bowel obstruction within 1 month of study treatment
  • History of abdominal fistula, intra-abdominal abscess, or gastrointestinal perforation within the 3 months of study treatment
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib or radium-223
  • Participants receiving strong CYP3A4/5 inducers or inhibitors are ineligible; dihydropyridine calcium-channel blockers are permitted for management of hypertension; the required washout period prior to starting olaparib is 2 weeks for CYP3A inhibitors; the required washout period prior to starting olaparib is 4 weeks for enzalutamide or phenobarbital and 3 weeks for other CYP3A inducers
  • Patients with known active hepatitis (i.e. hepatitis B or C) infection
  • Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
  • Patient having received prior allogenic bone marrow transplant or double umbilical cord blood transplantation
  • Individuals with a history of a different malignancy are ineligible except for the following circumstances:
  • Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy, or
  • Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: superficial bladder cancer, basal cell or squamous cell carcinoma of the skin

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Technical Success, Safety, and Short and Long-term Efficacy for MR-Guided Cryoablation of Prostate Bed Recurrences


Condition: Prostate Tumors

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01727284

Sponsor: Mayo Clinic

Eligibility:

  • Age: minimum 30 Years maximum 100 Years
  • Gender: Male

Inclusion Criteria:

  • Patients with "biopsy proven" soft tissue tumor recurrences of prostate fossa
  • Surgery is not a desirable alternative therapy at the time of enrollment
  • Radiation therapy has failed or not indicated or can be safely postponed
  • Tumor size is < 5 cm at its largest diameter
  • Tumor does not encompass the rectal wall or external urethral sphincter
  • Performance status is ECOG 2 or better in adults
  • Patient is able to undergo MRI

Exclusion Criteria:

  • Patients with pacemaker or defibrillator

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High Dose Rate Partial Prostate Brachytherapy as Salvage Treatment for Local Failures After Previous External Beam Radiotherapy


Condition: Recurrent Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03246802

Sponsor: British Columbia Cancer Agency

Eligibility:

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

Inclusion Criteria:

  • Age >45 and Life expectancy >10 years
  • Previous External Beam Radiotherapy (EBRT) dose up to 78Gray/39 fractions, 81 Gray/45 fractions or 70 Gray/28 fractions
  • > 3 year interval since EBRT
  • No late toxicity from prior EBRT > grade 2
  • Rising PSA post EBRT > nadir + 2 ng/ml but < 10 ng/ml
  • PSA Doubling time > 6 months
  • Negative staging with CT scan of the abdomen/pelvis and bone scan
  • Able to undergo multiparametric MRI with endorectal coil
  • Radiographic evidence of dominant intraprostatic lesion (DIL) as only area of recurrence (i.e unifocal recurrence) and corresponding to site of original disease
  • Biopsy confirmation of DIL with pathology review by British Columbia Cancer Agency GenitoUrinary pathologist (TB)
  • Willing to provide informed consent
  • History and physical examination within 90 days of registration
  • ECOG performance status 0-1 prior to registration
  • IPSS < 16, or adequate voiding study (post void residual < 100cc and peak flow rate > 10 cc/second).
  • No prior trans urethral prostatic resection
  • Recurrence suitable for implant with HDR brachytherapy as assessed on ultrasound simulation (maximum PTV ideally < 65% of prostate volume)
  • No history of inflammatory bowel disease or previous rectal surgery
  • Suitable for procedure under anesthesia, spinal or general
  • INR <2.5 and platelet count >75 x 109/L
  • Androgen Deprivation Therapy may be initiated at the discretion of the treating oncologist

Exclusion Criteria:

  • Not compliant with criteria above
  • Unable to give informed consent

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Phase I Trial of Image Guided Focally Dose Escalated Prostate SBRT for Locally Recurrent Prostate Cancer After Prior Radiotherapy


Condition: Prostate Cancer, Prosatatic Neoplasm

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03253744

Sponsor: National Cancer Institute (NCI)

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Patients must have histologically confirmed locally recurrent adenocarcinoma of the prostate after prior radiation (EBRT or brachytherapy).
  • PSA failure after definitive radiation as defined by the Phoenix criteria (PSA elevation at least 2 ng/dL above post-radiotherapy nadir)
  • Age greater than or equal to 18 years.
  • ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
  • Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients who are receiving any other investigational agents.
  • PSA greater than or equal to 20 ng/dL if no prior DCFPyL scan obtained (If PSA > 20 and DCFPyL obtained within 3 months prior to enrollment shows no evidence of metastatic disease, subjects may be included in the study)
  • Biochemical recurrence within one year of completion of radiotherapy
  • Need for chronic anticoagulation therapy (chronic low dose aspirin is not an exclusion)
  • Pre-existing and ongoing radiation-related grade 3 bowel or bladder toxicity
  • Inflammatory bowel disease
  • Active Lupus or Active scleroderma
  • Patients with distant metastatic disease (prostate adjacent adenopathy is not an exclusion)
  • Prior prostatectomy
  • Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results.
  • Subjects with severe claustrophobia that is unresponsive to oral anxiolytics
  • Other medical conditions deemed by the Principal Investigator (or associates) to make the subject unsafe or ineligible for protocol procedures
  • Subjects weighing > 350 lbs. (weight limit for scanner table), or unable to fit within the imaging gantry
  • Serum creatinine > 2 times the upper limit of normal
  • Total bilirubin > 2 times the upper limit of normal OR in patients with Gilbert s syndrome, a total bilirubin > 3.0.
  • Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal
  • Patients with positive Human Immunodeficiency Virus (HIV) status and currently requiring treatment with agents known to sensitize to irradiation, such as protease inhibitors.

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A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)


Condition: Small Cell Lung Cancer (SCLC), Follicular Lymphoma (FL), Castration Resistant Prostate Cancer (CRPC)

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03460977

Sponsor: Pfizer

Phase: Phase 1

Eligibility:

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

Key Inclusion Criteria:

  • Histological or cytological diagnosis of advanced / metastatic solid tumor with the following tumor types in individual study parts: Part 1A: Histologically / cytologically confirmed advanced/unresectable or metastatic SCLC, CRPC and FL that is refractory to or intolerable of standard treatment, or for which no curative treatment is available. Note for FL (Parts 1A and 1B) during the dose finding phase of study, follicular lymphoma patients must have exhausted all standard of care therapies. Part 1B: Histologically confirmed FL patients that have exhausted all curative therapies and have relapsed or refractory disease. Part 1C: Histological / cytological diagnosis of castration resistant prostate cancer. Received either abiraterone and/or enzalutamide treatment and has evidence of prostate cancer progression (per PWG3) Part 2A:
  • Histologically or cytologically confirmed treatment naïve extensive disease SCLC patients;
  • Histological / cytological diagnosis of castration resistant prostate cancer. Received either abiraterone and/or enzalutamide treatment and has evidence of prostate cancer progression (per PWG3) Part 2B: Histological / cytological diagnosis of castration resistant prostate cancer. Received abiraterone treatment and has evidence of prostate cancer progression (per PWG3)
  • Females and/or male patients age 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Adequate Bone Marrow Function
  • Adequate Renal Function
  • Adequate Liver Function
  • Serum pregnancy test (for females of childbearing potential) negative at screening, and negative serum or urine pregnancy test at baseline prior to treatment administration.

Exclusion Criteria:

  • Known symptomatic brain metastases requiring steroids or CNS involvement in FL. Previously diagnosed brain metastases are eligible if they have been treated and recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and are neurologically stable. Physiologic replacement doses of corticosteroids are permissible.
  • At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the SCLC patient).
  • Treatment with more than 2gm acetaminophen per day within 14 days of study entry and on study if required.
  • Chronic liver diseases.
  • History of alcohol abuse or binge drinking in the last 6 months prior to screening.
  • Radiation therapy within 4 weeks prior to study entry. Note, patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting.
  • Systemic anti cancer therapy
  • approved or investigational
  • within 4 weeks or 5 half-lives, whichever is shorter, prior to study entry, including antibody based agents. Prostate cancer patients in Part 2A must have not received more than 1 previous regimen of systemic chemotherapy in mCPRC setting and in Part 2B received not more than 1 previous regimen of chemotherapy in the mCSPC setting. Prostate cancer patients in Part 1C must not have received more than 2 previous regimens of chemotherapy in the mCRPC setting. SCLC cohorts must be chemotherapy naive for SCLC however may have received one cycle of chemotherapy after discussion with the sponsor.
  • Last anti hormonal therapy within 2 weeks prior to C1D1.
  • Prior stem cell transplant, autologous or allogenic, within 100 days prior to study enrollment or patients who experienced graft veses host disease or who require systemic immune suppressive therapy.
  • Prior irradiation to >25% of the bone marrow.
  • Active and clinically significant bacterial, fungal, or viral infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related illness.
  • Any of the following in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, arrhythmias (including sustained ventricular tachyarrhythmia and ventricular fibrillation), right bundle branch block and left anterior hemiblock (bifascicular block), unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism; ongoing cardiac dysrhythmias of NCI CTCAE Grade 2, atrial fibrillation of any grade, or QTcF interval >480 msec at screening.
  • Hypertension that cannot be controlled by medications (>150/100 mmHg despite optimal medical therapy).
  • Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC) or platinum compound.
  • Other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Pregnant female patients; breastfeeding female patients; fertile male patients and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 28days after the last dose of investigational product.
  • Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery. Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed.
  • Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors, including their administration within 10 days or 5 half lives of the CYP3A4/5 inhibitor, whichever is longer prior to first dose of investigational product.
  • Current use or anticipated need for drugs that are known strong CYP3A4/5 inducers, including their administration within 10 days or 5 half lives of the CYP3A4/5 inducer, whichever is longer prior to the first dose of investigational product.

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Multiparametric MRI for Assessing Radiotherapy Treatment Response of Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01607008

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility:

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

Inclusion Criteria:

  • Histologically-confirmed prostate cancer
  • Plan to undergo external radiation treatment of prostate cancer

Exclusion Criteria:

  • Patients who cannot undergo an MRIs
  • Patients who are allergic to gadolinium based contrast agent
  • Patients who have cardiac pacemaker or other electronic or metal implant
  • Patients who have chronic kidney disease

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A Randomized Clinical Trial of Exercise vs. Usual Care Among Men Opting for Active Surveillance for Prostate Cancer


Condition: Localized Prostate Cancer, Active Surveillance for Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02435472

Sponsor: University of California, San Francisco

Eligibility:

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

Inclusion Criteria:

  • ARM A and ARM B:
  • Histologically-documented localized (stage < T3) prostate adenocarcinoma
  • Patient has selected active surveillance as their management strategy for low- or low-intermediate risk prostate cancer as defined below
  • >= 10 core prostate biopsy completed prior to randomization with Gleason sum =< 6 with no pattern 4, or Gleason 3+4 in < 34% of all cores
  • Diagnostic or most recent prostate specific antigen (PSA) =< 15 ng/ml, or PSA density (PSAD) < 0.15
  • Low to moderate fitness level at baseline (to be assessed via interview with the exercise staff and through the CPET)
  • Clearance based on medical chart review and normal electrocardiogram (ECG) (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention
  • Able to achieve and complete an acceptable cardiopulmonary exercise test defined as follows: achieving peak or plateau in oxygen consumption concurrent with increased power output; a respiratory exchange ratio >= 1.1 or volitional exhaustion-rating of perceived exertion > 19
  • English-speaking
  • A priori, we will allow men with concurrent benign prostatic hyperplasia (prostate volume > 50 g) to have a PSA between 10-15 ng/ml; and include men with low volume Gleason 3+4 disease, because such men have similar outcomes on active surveillance to those with Gleason =< 3+3; also a priori, we will allow men with < than a 10 core biopsy at the discretion of the urologist if s/he classifies the patient as "low-risk" and a good candidate for active surveillance based on other favorable features (e.g., tumor molecular tests, prostate imaging, etc.) NON-CANCER CONTROL GROUP (EXPLORATORY ARM C):
  • Healthy males age 20-35 or >=60 yrs.
  • No history of prostate cancer or other cancer.
  • Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention OR medical clearance based on medical chart review and sub-maximal exercise testing for the remote aerobic training intervention.
  • English-speaking.
  • Low to moderate fitness level at baseline (to be assessed via interview with the exercise staff and through the CPET; similar to Arms A and B); subjects will be frequency-matched to subjects in the prostate cancer exercise intervention group (Arm A) to have a similar distribution of body mass index and facilitate comparisons between these two groups. NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:
  • Histologically-documented localized (stage < T3) prostate adenocarcinoma.
  • Undergoing or initiating active surveillance.
  • Medical clearance based on medical chart review and normal ECG (administered by a trained health professional) to undergo a symptom-limited cardiopulmonary exercise test and aerobic training intervention.
  • English-speaking. Exclusion Criteria
  • Any prior or concurrent treatment for prostate cancer
  • Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
  • Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:
  • Acute myocardial Infarction (within 5 days of any planned study procedure)
  • Unstable angina
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
  • Recurrent syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Symptomatic severe aortic stenosis
  • Uncontrolled heart failure
  • Acute (within 3 months) pulmonary embolus or pulmonary infarction
  • Thrombosis of lower extremities
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • Room air desaturation at rest =< 85%
  • Respiratory failure
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis)
  • Mental impairment leading to inability to cooperate NON-RANDOMIZED OBSERVATIONAL AND INTERVENTION COMPONENTS (ARM C): The same

Exclusion Criteria:

  • Any prior or concurrent treatment for prostate cancer
  • Use of finasteride or dutasteride within 3 weeks or 6 months, respectively, of study entry
  • Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to:
  • Acute myocardial Infarction (within 5 days of any planned study procedure)
  • Unstable angina
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
  • Recurrent syncope
  • Active endocarditis
  • Acute myocarditis or pericarditis
  • Symptomatic severe aortic stenosis
  • Uncontrolled heart failure
  • Acute (within 3 months) pulmonary embolus or pulmonary infarction
  • Thrombosis of lower extremities
  • Suspected dissecting aneurysm
  • Uncontrolled asthma
  • Pulmonary edema
  • Room air desaturation at rest =< 85%
  • Respiratory failure
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis)
  • Mental impairment leading to inability to cooperate NON-RANDOMIZED OBSERVATIONAL AND INTERVENTION COMPONENTS (ARM C): The same exclusion criteria apply as above. Additionally, • Should have no prior history of cancer, except for non-melanoma skin cancer

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Evaluation of PSMA-based PET as an Imaging Biomarker of Androgen Receptor Signaling in High-Risk Localized and Locally Advanced Prostate Cancer


Condition: Advanced Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02420977

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum 100 Years
  • Gender: Male

Inclusion Criteria:

  • Men 18 years of age or greater with recently diagnosed prostate cancer with planned radiation and ADT.

Key Inclusion Criteria:

  • (the entire list of inclusion and exclusion criteria will appear later in section 4 of the protocol)
  • Newly diagnosed prostate cancer pathologically proven by prostate biopsy
  • Prostate biopsy histology grade ≥ Gleason 8-10
  • Patients considered as candidates for and medically fit to undergo radiation and ADT
  • At least 10 days after most recent prostate biopsy

Exclusion Criteria:

  • will appear later in section 4 of the protocol)
  • Newly diagnosed prostate cancer pathologically proven by prostate biopsy
  • Prostate biopsy histology grade ≥ Gleason 8-10
  • Patients considered as candidates for and medically fit to undergo radiation and ADT
  • At least 10 days after most recent prostate biopsy Exclusion Criteria:
  • Prior pelvic external beam radiation therapy or brachytherapy
  • Chemotherapy for prostate cancer
  • Hormone deprivation therapy
  • Investigational therapy for prostate cancer
  • Hemorrhagic cystitis or active prostatitis

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Randomized, Multicentre Phase II Trial of the Sequencing of Radium-223 and Docetaxel Plus Prednisone in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer (mCRPC)


Condition: Metastatic Castration-resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03230734

Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Patients must have histologically or cytologically confirmed adenocarcinoma of prostate 2. Two or more bone metastases confirmed by bone scintigraphy within 4 weeks prior to study entry 3. Symptomatic disease defined as regular use of opioid or non-opioid analgesic medication or treatment with external beam radiation therapy within the previous 12 weeks for cancer-related bone pain 4. Known castration-resistant disease, defined according to the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria as: castrate serum testosterone level: ≤50 ng/dL (≤1.7 nmol/L) 5. Subjects who have failed initial hormonal therapy, either by orchiectomy or by using a gonadotropin-releasing hormone (GnRH) agonist in combination with an anti-androgen, must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks 6. Progressive disease based on prostate-specific antigen (PSA) and/or radiographic PCWG3 criteria:
  • Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first study treatment, each measurement at least one week apart. Serum PSA at screening ≥ 1ng/mL is the minimal starting value
  • or radiographic disease progression based on documented bone lesions by the appearance of two or more new lesions by bone scintigraphy 7. Patients who failed treatment with any Androgen deprivation therapy (ADT) abiraterone and/or enzalutamide for CRPC that must be terminated at least 4 weeks before study entry. 8. Male, aged ≥18 years. 9. Life expectancy of greater than 6 months. 10. Eastern Cooperative Oncology Group (ECOG) performance status≤2 . 11. Patients must have normal organ and marrow function as defined below:
  • leukocytes >3,000 x 10 9/L
  • absolute neutrophil count >1,500 x 10 9/L
  • platelets >100,000 x 10 9/L
  • total bilirubin within normal institutional limits
  • aspartate aminotransferase (AST/SGOT)/alanine aminotransferase (ALT/SGPT) <2.5 X institutional upper limit of normal
  • creatinine within normal institutional limits 12. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after the last dose of radium-223 or docetaxel, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials", (2014_09_15 section 4.1) . Two acceptable methods of birth control thus include condom (barrier method of contraception) and one of the following is required (established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy), for more than 6 months. 13. No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin). 14. Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

  • 1. Patients who have had previous chemotherapy. 2. Patients who have had radiotherapy within 4 weeks prior to entering the study. 3. Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 4. Concurrent use of other anticancer agents or treatments, with the following exceptions: luteinizing hormone-releasing hormone (LHRH) agonists or antagonists, denosumab or bisphosphonate (eg, zoledronic acid). Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed. 5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 6. Patients who received systemic radiotherapy (e.g. samarium, strontium etc.) for the treatment of bone metastases. 7. Patients who received blood transfusion or erythropoietin within the last 4 weeks prior to start of study treatment. 8. Patients who received prior treatment with Radium-223. 9. Patients with malignant lymphadenopathy exceeding 3 cm in short-axis diameter, or symptomatic nodal disease, i.e. scrotal, penile or leg edema. 10. Other primary tumor (other than CRPC) including hematological malignancy present within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer). 11. Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days. 12. Patients with imminent or established spinal cord compression based on clinical findings and/or magnetic resonance imaging. 13. Positive test for HIV 14. Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
  • Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen (anti-HBc) antibody test) are eligible.
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.

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A Phase I/II Study of Enzalutamide in Combination With Indomethacin in Castration-Resistant Prostate Cancer (CRPC)


Condition: Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02935205

Sponsor: Mamta Parikh

Phase: Phase 1/Phase 2

Eligibility:

  • Age: minimum 19 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed prostate cancer (CaP); CaP can be recurrent disease after definitive therapy (radical prostatectomy or radiation therapy) for localized CaP, or metastatic CaP
  • Patients must have CaP deemed to be castration-resistant by one or more of the following criteria (despite androgen deprivation when applicable):
  • Progression of unidimensionally measurable disease assessed within 42 days prior to initial administration of drug
  • Progression of evaluable but not measurable disease assessed within 42 days prior to initial administration of drug for PSA evaluation and for imaging studies (e.g, bone scans)
  • Rising PSA, defined as at least two consecutive rises in PSA to be documented over a reference value (measure 1); the first rising PSA (measure 2) should be taken at least 7 days after the reference value; a third confirmatory PSA measure (2nd beyond the reference level) should be greater than the second measure, and it must be obtained at least 7 days after the 2nd measure; if this is not the case, a fourth PSA measurement is required to be taken and be greater than the second measure
  • Measurable disease is not required
  • Patients who have measurable disease must have had X-rays, scans or physical examinations used for tumor measurement completed within 28 days prior to initial administration of drug
  • Patients must have non-measurable disease (such as nuclear medicine bone scans) and non-target lesions (such as PSA level) assessed within 28 days prior to initial administration of drug
  • Soft tissue disease that has been radiated within two months prior to registration is not assessable as measurable disease; soft tissue disease that has been radiated two or more months prior to registration is assessable as measurable disease provided that the lesion has progressed following radiation; as the biology of previously irradiated tumors may be different from non-irradiated tumors, patients must have at least one measurable lesion outside the previously irradiated region in order to be considered to have measurable disease
  • If PSA is the only indicator of disease and patients do not have any metastatic disease, PSA value must be 5.0 or higher
  • Patients must have been surgically or medically castrated; if the method of castration was luteinizing hormone-releasing hormone (LHRH) agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists; serum testosterone must be at castration levels (< 50 ng/dL) within 3 months prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 6 months
  • Leukocytes >= 3,000/mcL
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 1.5 x institutional upper limit of normal
  • Creatinine =< 1.5 x institutional upper limit of normal
  • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of enzalutamide administration
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patients who are receiving any other investigational agents within the preceding 4 weeks
  • Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES
  • Patient has received enzalutamide or ketoconazole for the treatment of prostate cancer; however, previous treatment with other hormonal therapy (bicalutamide, abiraterone, flutamide, and nilutamide) or chemotherapy (docetaxel, cabazitaxel, or mitoxantrone) is allowed
  • Other malignancies within the past 3 years except for adequately treated basal or squamous cell carcinomas of the skin or other stage 0 or I cancers
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or indomethacin
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
  • Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patients with an active bleeding diathesis
  • History of noncompliance to medical regimens
  • Patients unwilling to or unable to comply with the protocol
  • Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function, or spinal cord compression will be excluded from this study unless these issues have been taken care of
  • Patients with a history of seizure disorder, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, brain arteriovenous malformation
  • Patients with a history of peptic ulcer disease or gastrointestinal bleeding

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A Multi-Center Prospective Single Arm Intervention Trial Evaluating Focal Therapy Using High Intensity Focused Ultrasound (Sonablate 500) for Localized Prostate Cancer


Condition: Male Erectile Disorder, Prostate Cancer, Therapy-related Toxicity, Urinary Incontinence

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01194648

Sponsor: University College, London

Eligibility:

  • Age: minimum N/A maximum 90 Years
  • Gender: Male

Criteria: 1. Histologically proven prostate cancer on trans-rectal or transperineal template prostate biopsies. 2. Prostate biopsy (either TRUS or MRI Targeted or Template): - TRUS biopsy: up to burden bilateral disease with maximum 3mm one biopsy on non-dominant side is allowable. - MRI targeted and/or Template biopsy within 12 months of entry showing: - unilateral disease minimum 3mm of Gleason 3+3 or any Gleason 3+4 or 4+3 but not exceeding Gleason 4+3 overall OR - bilateral disease presence of clinically significant cancer on only one side (as determined by histological rules described above) Gleason ≤7 which is concordant with the MRI findings. 3. Stage T1-T2cN0M0 disease, as determined by local guidelines (radiological T3a permitted). 4. Serum PSA /=10 years. 6. Signed informed consent by patient. 7. An understanding of the English language sufficient to understand

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Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT)


Condition: Prostate Cancer, Localized Malignant Neoplasm

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT01766492

Sponsor: Georgetown University

Phase:

Eligibility:

  • Age: minimum 18 Years maximum 99 Years
  • Gender: Male

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of prostate
  • Signed study-specific consent
  • Prostate Specific Antigen (PSA) within 60 days of registration

Exclusion Criteria:

  • Prior pelvic radiotherapy
  • Prior radical prostate surgery
  • Medical or psychiatric illness that would interfere with treatment or follow up
  • Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery

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International Randomised Study of Laparoscopic Prostatectomy vs Stereotactic Body Radiotherapy (SBRT) and Conventionally Fractionated Radiotherapy vs SBRT for Early Stage Organ-Confined Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01584258

Sponsor: Royal Marsden NHS Foundation Trust

Phase: Phase 3

Eligibility:

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

Inclusion Criteria:

  • All of the following criteria are mandatory for inclusion:
  • Histological confirmation of prostate adenocarcinoma with a minimum of 10 biopsy cores taken within 18 months of randomisation.
  • Gleason score ≤ 3+4
  • Men aged ≥18
  • Clinical and MRI stage T1c -T2c, N0-X, M0-X (TNM 6th Edition [72], See Appendix 1)
  • PSA ≤ 20 ng/ml
  • Pre-enrollment PSA must be completed within 60 days of randomisation
  • Patients belonging in one of the following risk groups according to the National Comprehensive Cancer Network (www.nccn.org):
  • Low risk: Clinical stage T1-T2a and Gleason ≤ 6 and PSA < 10 ng/ml, or
  • Intermediate risk includes any one of the following:
  • Clinical stage T2b orT2c
  • PSA 10-20 ng/ml or
  • Gleason 3+4
  • WHO performance status 0
  • 2
  • Prostate volume ≤ 90 cc measured within 6 months of randomisation (height*width*length *π/6)
  • Ability of the research subject to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • One of the following criteria is sufficient for exclusion:
  • Clinical stage T3 or greater
  • Gleason score ≥ 4 + 3
  • High risk disease defined by National Comprehensive Cancer Network (www.nccn.org)
  • Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 5 year survival
  • Prior pelvic radiotherapy
  • Prior androgen deprivation therapy (including LHRH agonists and antagonists and anti-androgens)
  • Any prior active treatment for prostate cancer. Patients previously on active surveillance are eligible if they continue to meet all other

Eligibility Criteria:

  • .
  • Life expectancy <5 years
  • Bilateral hip prostheses or any other implants/hardware that would introduce substantial CT artifacts
  • Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel disease, significant urinary symptoms
  • Anticoagulation with warfarin/ bleeding tendency making fiducial placement or surgery unsafe in the opinion of the clinician (see section 11, Treatment).
  • Participation in another concurrent treatment protocol for prostate cancer

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