Prostate Cancer

{{header-clinical-trials-navigation}}

The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer


Condition: Prostate Cancer, Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04179968

Sponsor: Dana Mathews

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patients with suspected prostate cancer (e.g., abnormal digital rectal exam, elevated and/or rising PSA) as determined by referring physician
  • Patients must have had a diagnostic, standard of care mpMRI of the prostate with at least one lesion with a PI-RADS v2.1 score ≥ 4
  • In men with PI-RADS v2.1 score 4, PSA should be ≥ 10 ng/mL. In men with at least one PI-RADS v2.1 score 5 lesion, there is no restriction on PSA level.
  • Patients must be scheduled for biopsy or radical prostatectomy
  • Patients should not have had any type of curative or palliative therapy for prostate cancer before enrolling in the study
  • Patients must be medically stable as judged by the patient's physician
  • Patients must be able to lie still for a total of 60 minutes for the PET/CT scans
  • Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Patients who have had a prior prostatectomy or radiotherapy for prostate cancer cannot participate in the study
  • Patients who have had a prior biopsy for prostate cancer cannot participate in the study
  • Patients who have been treated for cancers other than skin cancers
  • Subjects may not be receiving any other investigational agents for the treatment of the cancer under study
  • Patients may not weigh more than the maximum weight limit for the PET/CT scanner table (>200 kilograms or 440 pounds)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-11 or other agents used in the study such as gadolinium-based intravenous contrast agent used during the mpMRI
  • Prior TURP/BPH procedures, including steam/laser therapies

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Single Fractions SBRT in the Treatment of Prostate Cancer: A Phase I Study


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04004312

Sponsor: Fabio Cury

Eligibility:

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

Inclusion Criteria:

  1. Histologically proven adenocarcinoma of the prostate. Tl-2b (AJCC 7th edition) Gleason score 6 or 7 (3+4)) or Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) Recent PSA under 15 ng/dL (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) OR Gleason 7(4+3) and recent PSA < 10 (less than 30 days; must obtained >90 days from stopping dutasteride or >30 days from stopping finasteride) International Prostate Symptom Score <16 Prostate gland volume< 80cc Zubrod Performance Status 0-1 within 60 days prior to registration Age >: 18 Patient must be able to provide study-specific informed consent prior to study entry.

Exclusion Criteria:

  1. Patients who opt to receive another treatment modality, such as surgery, or undergo active surveillance. Prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer). Evidence of distant metastases Regional lymph node involvement Previous radical surgery (prostatectomy), cryosurgery, or HIFU for prostate cancer Previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy Previous hormonal therapy, such as LHRH agonists or antagonists, anti-androgens, estrogens, or surgical castration (orchiectomy) Use of finasteride within 30 days prior to registration. PSA should not be obtained prior to 30 days after stopping finasteride. Use of dutasteride within 90 days prior to registration. PSA should not be obtained prior to 90 days after stopping dutasteride. Previous or concurrent cytotoxic chemotherapy for prostate cancer Severe, active co-morbidity, defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the last 6 months Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. (Patients on Coumadin or other blood thinning agents are eligible for this study.) Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Phase II Study of Single-Dose Image-Guided Radiotherapy (SDRT) With Urethral Sparing for Localized Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04035642

Sponsor: Fundacao Champalimaud

Eligibility:

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

Inclusion Criteria:

  • Signed study specific informed consent form;
  • Histologic confirmation of adenocarcinoma of the prostate by biopsy;
  • Up to 6 months of previous hormonal therapy is allowed (but not required)
  • PSA ≤ 20 prior to hormone therapy (if given);
  • Biopsy Gleason score ≤ 7
  • No direct evidence of regional or distant metastases after appropriate staging studies
  • Age ≥ 18
  • Performance Status 0-2
  • American Urological Association (AUA) score must be ≤ 20 (alpha blockers allowed)
  • Computerized Tomography (CT) or Ultrasound-based volume estimation of prostate gland ≤ 100 grams

Exclusion Criteria:

  • Positive lymph nodes or metastatic disease from prostate cancer on imaging studies
  • Prior invasive malignancy unless disease free for a minimum of 3 years
  • MRI evidence of radiographic T3, T4 or N1 disease
  • Tumour Clinical stage T3 or T4 on MRI
  • PSA > 20 ng/mL
  • Gleason score > 7
  • Previous pelvic radiotherapy
  • Previous surgery for prostate cancer
  • Recent transurethral resection of the prostate (TURP) (less than 3 months)
  • Previous hormonal therapy given for more than 6 months prior to therapy
  • Previous significant urinary obstructive symptoms;
  • Significant psychiatric illness
  • Ultrasound or CT estimate of prostate volume > 100 grams
  • Severe, active co-morbidity.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Pilot Study of Ultra-High-Dose Hypofractionated or Single-Dose Radiotherapy for Intermediate Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04147806

Sponsor: Albert Einstein College of Medicine

Phase: Phase 2

Eligibility:

  • Age: minimum 50 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Signed study specific informed consent form;
  • Histologic confirmation of adenocarcinoma of the prostate by biopsy;
  • PSA ≤ 20 ng/mL;
  • Gleason score 7;
  • Staging MRI must confirm American Joint Committee on Cancer (AJCC) stage T1, T2a, T2b or T2c;
  • No direct evidence of regional or distant metastases after appropriate staging studies;
  • Age ≥ 50;
  • Performance Status 0-2;
  • Internation Prostate Symptom Score score must be ≤ 15 (alpha blockers allowed);
  • CT scan or Ultrasound-based volume estimation of prostate gland ≤ 100 grams;

Exclusion Criteria:

  • Positive lymph-nodes or metastatic disease from prostate cancer on imaging studies
  • Prior invasive malignancy unless disease-free for a minimum of 5 years
  • Tumour Clinical stage T3 or T4 on MRI
  • PSA > 20 ng/mL
  • Gleason score > 7
  • Previous pelvic radiotherapy
  • Previous surgery for prostate cancer
  • Previous transurethral resection of the prostate (TURP)
  • History of Crohn's Disease or Ulcerative Colitis
  • Previous significant urinary obstructive symptoms
  • Significant psychiatric illness
  • Ultrasound or CT estimate of prostate volume > 100 grams
  • Severe, active co-morbidity

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Molecular Phenotyping and Image-Guided Surgical Treatment of Prostate Cancer Using Ultrasmall Silica Nanoparticles


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04167969

Sponsor: Memorial Sloan Kettering Cancer Center

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  • Primary RP + PLND
  • Age ≥18 years
  • Patients meeting one of the following criteria:
  • Tumor clinical stage T3a or higher
  • Gleason score 8-10, or
  • PSA level > 20 ng/mL
  • Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
  • Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance) Salvage PLND
  • Age ≥18 years
  • Patients with presence of suspicious lymph node on CT or MRI (of a pelvic node => 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or PSMA-avid on PSMA PET imaging
  • Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
  • Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance)

Exclusion Criteria:

  • Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)
  • Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
  • Prior pelvic radiotherapy (N/A for Salvage PLND )
  • Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer °This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR < 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease
  • Weight greater than the 400-lb weight limit of the PET scanner
  • Unmanageable claustrophobia
  • Inability to lie in the scanner for 30 min

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase II Single Arm Study of Fecal Microbiota Transplant (FMT) in Men With Metastatic Castration Resistant Prostate Cancer Whose Cancer Has Not Responded to Enzalutamide + Pembrolizumab


Condition: Prostate Cancer, Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04116775

Sponsor: Julie Graff, MD

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Be willing and able to provide written informed consent/assent for the trial prior to the performance of any protocol-related procedures that are not part of normal care. 2. Be ≥ 18 years of age at the time the informed consent is signed. 3. Histologically or cytologically documented adenocarcinoma of the prostate. Patients without histologically confirmed adenocarcinoma may be eligible if both the treating physician and the study PI agree that the patient's history is unambiguously indicative of advanced adenocarcinoma. 4. Receive care through a Veterans Affairs Hospital or is eligible for care at VHA. 5. Have metastatic castration resistant prostate cancer with castrate-level testosterone (<50 ng/dL). a. Participants must maintain a castrate-level testosterone during the study. 6. Have disease progression defined by one or more of the following three criteria: 1. PSA > 2.0 ng/mL at time of screening and rising PSA by at least 2 consecutive measurements a minimum of 1-week apart. 2. Soft tissue progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 3. Bone disease progression as defined by the PCWG3. 7. Have measurable disease based on RECIST v.1.1 modified as described by the PCWG3 or non-measurable disease with bone metastases. a. Participants with measurable disease must have at least one lesion that is ≥10 mm in longest diameter for a soft tissue lesion, or ≥15 mm in short axis for a lymph node. 8. Have a metastatic lesion that can be safely biopsied and be willing to undergo the tumor biopsy. If the participant is on anticoagulation, it must be safe to hold the anticoagulation for the biopsy. 9. Have had a PSA response to enzalutamide (defined as a PSA decline of 50% or more), but now showing signs of PSA and/or radiographic progression per PCWG3 and/or RECIST 1.1. (Patients must be continuously on enzalutamide prior to joining the main study. They may not have had progression on enzalutamide and then challenge with new therapy and then restarted on enzalutamide.) 10. Participants must discontinue antiandrogen therapy (ie, bicalutamide, flutamide, nilutamide) at least 4-6 weeks prior to registration with no evidence of PSA decline after washout. 1. Bicalutamide: Washout period at least 6 weeks 2. Flutamide and nilutamide: Washout period at least 4 weeks 11. Participants must discontinue therapies for mCRPC, with the exception of enzalutamide and a GnRH agent, for 5 half-lives or 28 days, whichever is shorter. 1. Prior treatment with sipuleucel-T, radium-223, or abiraterone is allowed. 2. Tissue biopsy may be performed during washout period. 12. Have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale. 13. Demonstrate adequate organ function on screening laboratory tests performed within 14 days of treatment initiation and as evidenced by: 1. Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within ≤ 7 days of assessment) 2. WBC > 2,000/mm3 without growth factor support (within ≤ 7 days days of assessment) 3. Absolute neutrophil count ≥ 1,500/mm3 without growth factor support or transfusion (within < 28 days of assessment) 4. Platelet count ≥ 100,000/mm3 5. Serum creatinine < 1.5 x upper limit of normal (ULN) or measured or calculated (calculated per institutional standard) creatinine clearance ≥ 60 mL/min for participant with creatinine levels > 1.5 x institutional ULN. GFR can also be used in place of creatinine or CrCl. 6. Serum total bilirubin < 1.5 x ULN or ≤ 2.0 x ULN for participants with liver metastases
  • Participants with Gilbert's syndrome must have ≤ 3 x ULN and no liver lesions 7. Aspartate transaminase (AST) (SGOT) and alanine transaminase (ALT) (SGPT) ≤ 2.5 x ULN or ≤ 5.0 x ULN for participants with liver metastases. 8. Albumin ≥ 2.5 mg/dL. 9. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, as long as PT is within therapeutic range of intended use of anticoagulants. 10. Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, as long as PTT is within therapeutic range of intended use of anticoagulants. 14. Male participants of reproductive potential must agree to use an adequate method of contraception, starting with the first dose of study intervention and through 120 days after the last dose of study therapy. Contraception is not required if the patient's partner is a woman who is post-menopausal. Subjects of reproductive potential must agree to avoid impregnating a partner by complying with one of the following: Practice abstinence from heterosexual activity; abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception. OR Have their partner use acceptable contraception during heterosexual activity. Acceptable methods of contraception are: Single method (one of the following is acceptable):
  • Intrauterine device (IUD)
  • Contraceptive rod implanted into the skin. Combination method (requires use of two of the following):
  • Diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide)
  • Cervical cap with spermicide (nulliparous women only)
  • Contraceptive sponge (nulliparous women only)
  • Male condom or female condom (cannot be used together)
  • Hormonal contraceptive: oral contraceptive pill (estrogen/progestin pill or progestin-only pill), contraceptive skin patch, vaginal contraceptive ring, or subcutaneous contraceptive injection. 15. Participants must be able and willing to comply with the study visit schedule and study procedures.

Exclusion Criteria:

  1. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy. Superficial bladder cancer is also permitted provided it is monitored and treated locally.
  2. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least 4 weeks prior to the first dose of study intervention and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to study intervention. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability.
  3. Uncontrolled disease-related bone pain or other symptoms that suggest the participant should imminently go onto chemotherapy.
  4. Those with tumors having known microsatellite instability will be excluded. Participants found to have microsatellite instability in their tumors after analysis of the on-study biopsy will not be eligible to serve as FMT donors, but will be permitted on the study.
  5. Prior taxane-based chemotherapy (in any setting- castration sensitive or resistant).
  6. Has had prior therapy with an anti-CTLA4, anti-PD-1 or anti-PD-L1 antibody.
  7. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to the first dose of study treatment or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  8. 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.
  9. Has had prior targeted small molecule therapy within 2 weeks prior to the first dose of study treatment or who has not recovered (ie, ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
  10. Note: Participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
  11. Note: If a participant received major surgery, he must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  12. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  13. Has received broad-spectrum antibiotics within 3 months of first dose of pembrolizumab.
  14. Has a history of seizure, unless he had a mass in his brain that has been removed, such as a meningioma.
  15. Has a diagnosis of immunodeficiency or conditions that need systemic corticosteroid replacement therapy > 10 mg/day prednisone (or equivalent) or other immunosuppressive medications within 28 days prior to the first dose of study intervention. Inhaled steroids are permitted if necessary.
  16. Has any active known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, controlled autoimmune hypothyroidism, psoriasis not requiring systemic treatment, or other conditions under control are permitted to enroll. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy < 10 mg of prednisone/day for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  17. Has a known history of active TB (Bacillus Tuberculosis).
  18. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis .
  19. Has an active infection requiring systemic therapy.
  20. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
  21. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  22. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients Testing positive for any of the following infectious diseases (criteria 21-22).
  23. Evidence of the following infectious agents:
  24. Stool pathogens: Clostridium difficilie toxin B by PCR, Giardia antigen, Cryptosporidium antigen, Acid-fast stan for Cyclospora or Isospora, Ova and parasites, Helicobacterial pylori antigen positivity, Salmonella spp., Shigella spp., Campylobacter spp., Shiga-toxin producing Escherichia coli, Methicillin Resistant Staphylococcus aureus, Vancomycin Resistant Enterococcus spp., Carbapenem Resistant Enterobacteriaceae, ESBL producing E. coli, Aeromonas spp., Plesiomonas spp., Yersinia spp., Vibrio spp., Entamoeba histolytica, Rotavirus, Adenovirus, Norovirus
  25. Blood pathogens: Positive for HIV, type 1 or 2; Hepatitis A IgM; Hepatitis B antigen, anti-HBC (both IgG and IgM), and anti-HBs; Hepatitis C antigen; T. pallidum antibody; FTA-ABS (if positive T. pallidum screen)
  26. COVID-19 (unless vaccinated against COVID-19)
  27. Risk factors for contracting an illness:
  28. Ongoing high-risk behaviors (e.g. men who have sex with men, men who have sex for money, men who use intravenous drugs)
  29. Tattoo or body piercing within 6 months
  30. Risk factors for Creutzfeldt-Jakob disease
  31. Travel within the past 6 months to areas of the world where diarrheal illnesses are endemic or risk of traveler's diarrhea is high
  32. Known current communicable disease (e.g. upper respiratory infection).
  33. Gastrointestinal co-morbidities: history of inflammatory bowel disease, history of irritable bowel syndrome or idiopathic chronic constipation, history of chronic diarrhea related to inflammatory bowel disease with current diarrheal symptoms, history of gastrointestinal malignancy or known polyposis.
  34. Major immunosuppressive medications, e.g., calcineurin inhibitors, exogenous glucocorticoids, biologic agents, etc.
  35. Systemic antineoplastic agents other than enzalutamide and LHRH agonist or antagonist in the past 4 weeks.
  36. Has received a live vaccine within 30 days of planned start of study intervention. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

The EXOPRO Study: How Does Prostate Cancer Metastasize? Understanding the Role of Exosomal Communication in Lean vs Obese Patients


Condition: Prostate Cancer, Obesity

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04167722

Sponsor: Imperial College London

Phase:

Eligibility:

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

Inclusion Criteria:

  • All men undergoing radical prostatectomy at Charing Cross Hospital

Exclusion Criteria:

  • Patients unable to consent

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Phase II Trial of pTVG-HP DNA Vaccine With or Without pTVG-AR DNA Vaccine and Pembrolizumab in Patients With Castration-Resistant, Metastatic Prostate Cancer


Condition: Castration-resistant Prostate Cancer, Metastatic Cancer, Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04090528

Sponsor: University of Wisconsin, Madison

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate)
  • Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT of abdomen/pelvis, bone scintigraphy)
  • Castrate-resistant disease, defined as follows:
  • All participants must have received (and be receiving) standard of care androgen deprivation treatment (surgical castration versus GnRH analogue or antagonist treatment); subjects receiving Gonadotropin-releasing hormone (GnRH) analogue or antagonist must continue this treatment throughout the time on this study.
  • Participants may or may not have been treated previously with a nonsteroidal antiandrogen. For participants previously treated with an antiandrogen, they must be off use of anti-androgen for at least 4 weeks (for flutamide, apalutamide, enzalutamide, or other 2nd generation AR antagonists) or 6 weeks (for bicalutamide or nilutamide) prior to registration. Moreover, participants who demonstrate an anti-androgen withdrawal response, defined as a > 25% decline in PSA within 4-6 week of stopping a nonsteroidal antiandrogen, are not eligible until the PSA rises above the nadir observed after antiandrogen withdrawal.
  • Participants must have a castrate serum level of testosterone (< 50 ng/dL) within 6 weeks of day 1
  • Progressive disease while receiving androgen deprivation therapy defined by any one of the following as per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) bone scan criteria or RECIST 1.1 during or after completing last therapy:
  • PSA: At least two consecutive rises in serum PSA, obtained at a minimum of 1-week intervals, with the final value > 2.0 ng/mL.
  • Measurable disease: > 50% increase in the sum of the cross products of all measurable lesions or the development of new measurable lesions. The short axis of a target lymph node must be at least 15 mm by spiral CT to be considered a target lesion
  • Non-measurable (bone) disease: The appearance of two or more new areas of uptake on bone scan (or Sodium Fluoride (NaF) positron emission tomography-computed tomography (PET/CT)) consistent with metastatic disease compared to previous imaging during castration therapy. The increased uptake of pre-existing lesions on bone scan will not be taken to constitute progression, and ambiguous results must be confirmed by other imaging modalities (e.g. X-ray, CT or MRI).
  • Prior treatment with abiraterone or enzalutamide is permitted, but participants must have weaned to a daily corticosteroid dose equivalent of no more than 5 mg prednisone daily for at least 28 days prior to day 1.
  • Life expectancy of at least 6 months
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Adequate hematologic, renal, liver, and coagulation function as evidenced by the following within 6 weeks of day 1:
  • White Blood Cells (WBC) >/= 2000 / mm3
  • Absolute Neutrophil Count (ANC) >/= 1500 / mm3
  • Hemoglobin (HgB) >/= 9.0 gm/dL (Participants must not have received a blood transfusion within 14 days)
  • Platelets >/= 100,000 / mm3
  • Creatinine
  • Total bilirubin 1.5 x ULN
  • Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT)
  • Prothrombin Time (PT) or International Normalized Ratio (INR)
  • Partial Thromboplastin Time (PTT)
  • No known history of human immunodeficiency viruses (HIV 1 and 2), Human T-cell leukemia virus type 1 (HTLV-1), or active Hepatitis B or Hepatitis C
  • Participants must be at least 4 weeks from any prior treatments and have recovered (to < Grade 2) from acute toxicity attributed to this prior treatment, unless considered chronic
  • A subset of participants (6 participants per treatment arm) treated at the lead University of Wisconsin (UW) site must be willing and able (in the opinion of the treating physician) to undergo two research biopsies for the investigational component of this trial.
  • A subset of participants (6 participants per treatment arm) treated at the lead UW site must be willing to undergo NaF PET/CT scans for the investigational component of this trial.
  • For those participants who are sexually active, they must be willing to use barrier contraceptive methods, and refrain from donating sperm, during the period of treatment on this trial and for four weeks after the last DNA immunization treatment
  • Participants must be informed of the experimental nature of the study and its potential risks, and must sign an Institutional Review Board (IRB)-approved written informed consent form indicating such an understanding

Exclusion Criteria:

  • Small cell or other variant (non-adenocarcinoma) prostate cancer histology, unless there is evidence that the tumor expresses PAP
  • Participants may not be receiving other investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy
  • Concurrent bisphosphonate therapy is not excluded, however participants should not start bisphosphonate therapy while on this study; those participants already receiving bisphosphonate therapy should continue at the same dosing and schedule as prior to study entry
  • Rapidly progressive symptomatic metastatic disease, as defined by the need for increased opioid analgesics within one month of registration for the treatment of pain attributed to a prostate cancer metastatic lesion; participants receiving opioids must receive approval from the PI for eligibility
  • Treatment with any of the following medications within 28 days of day 1, or while on study, is prohibited:
  • Systemic corticosteroids (at doses over the equivalent of 5 mg prednisone daily); inhaled, intranasal or topical corticosteroids are acceptable
  • Prostate Cancer and spes (PC-SPES)
  • Megestrol
  • Ketoconazole
  • 5-α-reductase inhibitors
  • participants already taking 5-α-reductase inhibitors prior to 28 days prior to registration may stay on these agents throughout the course of therapy, but these should not be started while participants are on study
  • Diethyl stilbesterol
  • Abiraterone
  • Enzalutamide
  • Apalutamide
  • Radium 223 (Xofigo®)
  • Any other hormonal agent or supplement being used with the intent of cancer treatment must be reviewed by the PI for eligibility
  • External beam radiation therapy within 4 weeks of registration is prohibited, or anticipated need for radiation therapy (e.g. imminent pathological fracture or spinal cord compression) within 3 months of registration. Participants must have recovered from all radiation-related toxicities and not have had radiation pneumonitis.
  • Major surgery within 4 weeks of registration is prohibited
  • Prior cytotoxic chemotherapy (for example, but not limited to, docetaxel, mitoxantrone, cabazitaxel) within 28 days of registration is prohibited
  • Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with any agent directed to another T-cell stimulatory or inhibitory receptor (e.g. CTLA-4, OX-40, CD137).
  • Participants with a history of life-threatening autoimmune disease
  • Participants with a history of non-infectious pneumonitis that required corticosteroid treatment, or has current pneumonitis
  • Participants with a history of allergic reactions to the tetanus vaccine
  • Participants who have undergone splenectomy or who have a diagnosis of immunodeficiency
  • Participants must not have other active malignancies other than non-melanoma skin cancers or superficial (non-muscle-invasive) carcinoma of the bladder. Participants with a history of other cancers who have been adequately treated and have been recurrence-free for > 3 years are eligible.
  • Participants with known brain metastases and/or carcinomatous meningitis
  • Participants who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette
  • Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
  • Any antibiotic therapy within 1 month of day 1, or anticipated need for antibiotic therapy within 1 month of beginning treatment
  • Participants with active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Any other medical intervention or condition, which, in the opinion of the PI or treating physician, could compromise participant safety or adherence with the study requirements (including biopsies), or confound results of the study, over the treatment period.
  • Any known psychiatric or substance abuse disorders that would interfere with cooperation with the requirement of the trial.
  • Participants cannot have concurrent enrollment on other phase I, II, or III investigational treatment studies.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Reducing Prostate Cancer Disparities Among African Americans


Condition: Cancer Survivor, Partner, Spouse, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage IIA Prostate Cancer AJCC v8, Stage IIB Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IIIA Prostate Cancer AJCC v8, Stage IIIB Prostate Cancer AJCC v8, Stage IIIC Prostate Cancer AJCC v8

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04215029

Sponsor: M.D. Anderson Cancer Center

Eligibility:

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

Inclusion Criteria:

  • To be eligible, prostate cancer survivors must self-identify as black or African American
  • Prostate cancer survivors must have 0-III stage prostate cancer
  • Prostate cancer survivors must have completed therapy (e.g., surgery, chemotherapy [chemo] and/or radiation)
  • Prostate cancer survivors must enroll with a spouse or a romantic partner
  • Prostate cancer survivors must not meet physical activity recommendation (i.e., 150 minutes of moderate intensity physical activity per week)
  • Prostate cancer survivors must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q)
  • Prostate cancer survivors must not participate in another physical activity, diet, or lifestyle program
  • Prostate cancer survivors must have a valid home address and telephone number
  • Prostate cancer survivors must be able to access internet over a smartphone or a computer at home or other location (e.g., work, church, library, community center, etc.)
  • To be eligible, spouses or romantic partners must be >=18 years of age
  • Spouses or romantic partners must enroll with a spouse or a romantic partner with prostate cancer
  • Spouses or romantic partners must live together with the survivors
  • Spouses or romantic partners must not have major health problems (e.g., cancer, dementia, stroke, and heart and lung diseases)
  • Spouses or romantic partners must be willing and able to be physically active, as determined by responses to the Physical Activity Readiness Questionnaire (PAR-Q)
  • To be eligible, healthcare providers must be currently providing care with individuals diagnosed with prostate cancer
  • Any professionals such as surgical and medical oncologists, fellows, nurse practitioners, physical assistants, and primary care physicians will be eligible Exclusion Criteria:
  • Prostate cancer survivors will be excluded if they are not married or partnered
  • Prostate cancer survivors will be excluded if they have an active noncutaneous malignancy at any site
  • Prostate cancer survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
  • Prostate cancer survivors will be excluded if they have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period
  • Prostate cancer survivors will be excluded if they are on active surveillance
  • Prostate cancer survivors will be excluded if they enrolled in a protocol #: 2017-0556
  • Prostate cancer survivors will be excluded if they are not able to understand and speak English
  • Spouses or romantic partners who are not able to understand and speak English will be excluded
  • Also, spouses or romantic partners who enrolled in a protocol (#2017-0556) will be excluded
  • There are no

Exclusion Criteria:

  • Prostate cancer survivors will be excluded if they are not married or partnered
  • Prostate cancer survivors will be excluded if they have an active noncutaneous malignancy at any site
  • Prostate cancer survivors will be excluded if they had a prior history of other cancer or have metastatic cancer
  • Prostate cancer survivors will be excluded if they have planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy during the study period
  • Prostate cancer survivors will be excluded if they are on active surveillance
  • Prostate cancer survivors will be excluded if they enrolled in a protocol #: 2017-0556
  • Prostate cancer survivors will be excluded if they are not able to understand and speak English
  • Spouses or romantic partners who are not able to understand and speak English will be excluded
  • Also, spouses or romantic partners who enrolled in a protocol (#2017-0556) will be excluded
  • There are no exclusion criteria for healthcare providers

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

An Exploratory proof-of Valid Biomarkers in Blood to Predict the Response to Therapy in Prostate Cancer Patients, a Single Center Study


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03408964

Sponsor: Andrea Alimonti

Phase:

Eligibility:

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

Inclusion Criteria:

  • General inclusion criteria (for entering all groups)
  • Age ≥ 18 years
  • Histological diagnosis of prostate adenocarcinoma at different stages of disease (see Section 6.2) for which a treatment is indicated
  • Written Informed Consent Inclusion criterion only for entering Group 0 • Patients with a known diagnosis of CSPC or CRPC Inclusion criterion only for entering Group 1a • Patients that underwent biopsies for a suspect of PC, but resulted negative for cancer Exclusion Criteria: General exclusion criteria (for entering all groups)
  • Active infection requiring treatment
  • Decrease of general condition
  • Concomitant severe comorbities
  • Difficult socioeconomic conditions making regular follow up unfeasible.
  • Need of concomitant steroids at study entry and during the study
  • Diagnosis of second tumor in the previous 5 years Exclusion criterion only for entering Group 0 • No antibiotic treatments in the previous 2 months before enrollment Exclusion criteria only for entering Group 1
  • Previous radical surgery and / or radical radiotherapy
  • Previous hormonal treatments

Exclusion Criteria:

  • General exclusion criteria (for entering all groups)
  • Active infection requiring treatment
  • Decrease of general condition
  • Concomitant severe comorbities
  • Difficult socioeconomic conditions making regular follow up unfeasible.
  • Need of concomitant steroids at study entry and during the study
  • Diagnosis of second tumor in the previous 5 years Exclusion criterion only for entering Group 0 • No antibiotic treatments in the previous 2 months before enrollment Exclusion criteria only for entering Group 1
  • Previous radical surgery and / or radical radiotherapy
  • Previous hormonal treatments Exclusion criteria only for entering Group 2
  • No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics)
  • Previous hormonal treatments for advanced disease Exclusion criterion only for entering Group 3 • No antibiotic treatments in the previous 2 months before enrollment (only in patients enrolling also for metagenomics and metabolomics analyses)

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Office Based MRI/Ultrasound Guided Prostate Cryotherapy: Outcomes Registry


Condition: Neoplasms Prostate, Cancer of the Prostate

Study Type: Observational [Patient Registry]

Clinical Trials Identifier NCT 8-digits: NCT02381990

Sponsor: Urological Research Network, LLC

Phase:

Eligibility:

  • Age: minimum 55 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Men between 55 and 65 years of age with a clinical diagnosis of prostate cancer with Low or Intermediate risk prostate cancer, and <50% positive core rate by prostate lobe
  • Men older than 65 years of age with clinical diagnosis of prostate cancer <50% positive core rate by prostate lobe
  • Absence of extra-capsular extension
  • Absence of seminal vesicle invasion
  • Absence of regional or distant metastatic disease
  • Multiparametric MRI of the prostate performed either before the biopsy or >10 weeks after prostate biopsy
  • Treated with Cryotherapy of the prostate
  • Treatment based on co-registration between MP-MRI and Prostate Ultrasound

Exclusion Criteria:

  • Prior treatment of prostate cancer in the form of surgery.
  • Performance status greater than 0 based on ECOG criteria
  • Mental status impairment

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A Phase I/IIa Study Evaluating the Safety and Tolerability of Intratumoral Administration of ORCA-010 in Treatment-Naïve Patients With Localized Prostate Cancer.


Condition: Adenocarcinoma of the Prostate

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04097002

Sponsor: Orca Therapeutics B.V.

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Histologically confirmed adenocarcinoma of the prostate, which is localized to the prostate ( within 24 months of screening) 2. Absence of lymph node, bone or other metastases as determined by MRI and CT scan, Bone Scan or nano-MRI (≤3 months prior to first administration) 3. Men between 18 and 75 years inclusive 4. ECOG status 0 or 1 5. Ability to understand and willingness to sign informed consent 6. Adequate liver, renal and bone marrow function: AST & ALT < 2.5 x ULN, total bilirubin < 1.5 x ULN, Alkaline phosphatase < 3 x ULN, Serum creatinine < 1.5 x ULN, Haemoglobin > 9.0 g/dL (5.59 mmol/L), Platelet count > 100x10*9/L, Neutrophils > 1.5x10*9/L, INR < 1.5xULN 7. eGFR ≥ 30 mL/min, using the Cockcroft
  • Gault Equation: Creatinine Clearance = [{(140
  • age in years) x (weight in kg)} x 1.23] /serum Creatinine in Mmol/L

Exclusion Criteria:

  1. Tumor not accessible for injection
  2. Prior treatment of prostate cancer with radiation therapy or brachytherapy
  3. Prior use of chemotherapy/hormone therapy for treatment of cancer
  4. Target tumor adherent to a major vascular structure
  5. Participation in any investigational drug study within the last 12 months prior to first administration of ORCA-010
  6. Clinically significant active infection (viral or bacterial)
  7. Known immunosuppressive diseases (e.g. HIV, Hepatitis B and C)
  8. History of any other oncological malignancy, excluding basal cell carcinoma of the skin, in the past 5 years
  9. Not willing to refrain from sexual activities or use a double barrier contraceptive device (condom with foam or vaginal suppository, diaphragm with spermicide) after administration of ORCA-010 and until 42 days after the last ORCA-010 administration
  10. Severe obesity defined as Body Mass Index (BMI) > 30 kg/m2
  11. Positive for adenovirus in throat swap or serum as determined by PCR at screening
  12. Recent (within 3 months prior to enrolment in the study) history of alcohol abuse or other substances such as barbiturates, cannabinoids and amphetamines or a positive urine screen for drugs of abuse
  13. Use of medication known to have immunosuppressive effects, except topical/inhaled steroids under 10 mg/day prednisolone equivalent (See Appendix 7)
  14. Use of systemic antiviral medication within 3 months prior to enrolment in the study
  15. Use of any anti-coagulants/blood thinner except for ASA 81mg
  16. Any condition that in the opinion of the Investigator could interfere with the conduct of the study
  17. For Part B only: Subjects enrolled in Part A of the study

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

A First-in-Human Study to Determine the Safety, Pharmacokinetics and Efficacy of KPG-121 When Administered With Enzalutamide, Abiraterone, or Apalutamide in Subjects With Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer


Condition: Castration-Resistant Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03569280

Sponsor: Kangpu Biopharmaceuticals, Ltd.

Phase: Phase 1

Eligibility:

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

Inclusion Criteria:

  1. Signed informed consent provided prior to any study-related procedure being performed;
  2. Able to swallow and retain orally administered medication;
  3. Male aged 18 years and older (adult, older adult) at the time consent is obtained;
  4. Histologically or cytologically confirmed diagnosis of prostate carcinoma;
  5. Men with either non-metastatic or metastatic CRPC are eligible;
  6. Completed at least 4 or more weeks of prior continuous therapy with fixed stable dose enzalutamide, abiraterone or apalutamide prior to initiating study treatment (for Part 1), or with fixed stable dose enzalutamide (for Part 2), with no change in dose for at least 2 weeks prior to screening;
  7. Serum testosterone level <50 ng/dL (<0.5 ng/mL, <7.0 nmol/L). Subjects may have ongoing androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) "super-agonist" or antagonist, and/or be surgically or medically castrated;
  8. ECOG performance status of 0 or 1;
  9. Adequate baseline organ function;
  10. Must have a QT interval corrected for heart rate according to Fridericia's formula (QTcF) <470 milliseconds (msec) or <480 msec with bundle branch block;
  11. Male subject with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from time of screening until 3 months after the last dose of study medication;
  12. Willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria:

  1. Life expectancy less than 3 months;
  2. Discontinuation of bicalutamide or nilutamide in less than 6 weeks, and other antiandrogens in less than 4 weeks, prior to the start of study medication;
  3. Prior chemotherapy, radiation (limited radiotherapy to control bone pain is permitted), sipuleucel-T or other experimental immunotherapy less than 4 weeks prior to the start of study medication;
  4. Prior malignancy other than CRPC. Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible;
  5. Screening blood counts with:
  6. absolute neutrophil count <1500/μL
  7. platelets <100,000/μL
  8. hemoglobin <9 g/dL;
  9. Screening chemistry test results with:
  10. alanine aminotransferase (ALT) and aspartate transaminase (AST) >2.5 × ULN
  11. total bilirubin >2 × ULN
  12. for the dose escalation cohort, creatinine clearance of <70 mL/min as determined by Cockcroft and Gault formula
  13. for the dose expansion cohort, subjects with creatinine clearance of <50 mL/min will be excluded (if kidneys are not working properly, there is a risk that KPG-121 may stay in the blood circulation longer than expected and may increase side-effects)
  14. albumin <2.8 g/dL;
  15. Uncontrolled hypothyroidism, or TSH >2.0 x ULN at screening. Subjects who are clinically euthyroid and on stable thyroid replacement therapy for 2 months prior to enrollment are allowed;
  16. Current use of or anticipated requirement during the study of prohibited medication(s), any investigational drug, other anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, or hormone therapy other than for replacement), AR antagonists (e.g., bicalutamide, flutamide, nilutamide), 5-alpha reductase inhibitors (e.g., finasteride, dutasteride), androgens (e.g., testosterone, dihydroepiandrosterone), Herbal medication(s) that may affect PSA levels (e.g., saw palmetto), Other herbal medications including, but not limited to: St. John's wort, kava, ephedra (ma huang), gingko biloba, yohimbe and ginseng);
  17. Any unresolved ≥grade 2 (per CTCAE v5.0) toxicity from previous anti-cancer therapy at the time of enrollment, except for grade 2 alopecia, anemia (if hemoglobin is >9.0 g/dL) or neuropathy;
  18. Any ≥grade 2 hypophosphatemia (per CTCAE v5.0) at the time of enrollment;
  19. Serum calcium ≥grade 1 (per CTCAE v5.0) at time of enrollment, unless ionized calcium is within normal range;
  20. Presence of any clinically significant gastrointestinal (GI) abnormality or other condition(s) that may alter absorption such as malabsorption syndrome or major resection of the stomach or substantial portion of the small intestine;
  21. Active peptic ulcer disease or history of abdominal fistula, GI perforation, or intra abdominal abscess within 28 days prior to enrollment;
  22. Previous history of difficulty swallowing capsules;
  23. Known active infection requiring intravenous (IV) or oral anti-infective treatment or serious persistent infection within 14 days prior to the start of study medication;
  24. Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to the start of study medication;
  25. Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal or cardiac disease);
  26. History of seizure or any condition that may predispose subject to seizure (e.g., prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months prior to the start of study medication;
  27. Poorly controlled hypertension (defined as systolic BP ≥150 mmHg) or diastolic BP >100 mmHg based on a mean of three measurements at approximately 2-minute intervals);
  28. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to enzalutamide or abiraterone or apalutamide or excipients. Allergy to acetaminophen or NSAIDs;
  29. History of impaired adrenal gland function (e.g., Addison's disease, Cushing's syndrome);
  30. History or evidence of cardiovascular risk including any of the following: Clinically significant ECG abnormalities including second degree (Type II) or third degree atrioventricular block; history of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, stenting, or bypass grafting within 6 months prior to enrollment, Class III or IV heart failure as defined by the New York Heart Association functional classification system, left ventricular ejection fraction (LVEF) below 45% at screening; known cardiac metastases;
  31. Anticoagulants used by subjects with a history of thromboembolic conditions within 6 months prior to enrollment. Note: Subjects receiving anticoagulants for atrial fibrillation are eligible for the study;
  32. Use of systemic glucocorticoid (e.g., prednisone, dexamethasone) within 14 days prior to the start of study medication;
  33. Serious concurrent medical condition including central nervous system disorders;
  34. Previous major surgery within 30 days prior to the start of study medication;
  35. Blood transfusion (including blood products) within 1 week of screening;
  36. Any condition that, in the opinion of the investigator, would impair the subject's ability to comply with study procedures.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Validating the miR Scientific Sentinel™ Platform (Sentinel PCC4 Assay) in Men Undergoing Core Needle Biopsy Due to Suspicion of Prostate Cancer for Distinguishing Between no Cancer, Low-, Intermediate- and High-Risk Prostate Cancer


Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04100811

Sponsor: miR Scientific LLC

Phase:

Eligibility:

  • Age: minimum 45 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  1. Males ≥ 45 years old
  2. Males with clinical suspicion of prostate cancer, including but not limited to elevated PSA level, suspicious DRE, family history of prostate cancer, and/or germline mutation, who as a result undergo TRUS- or MRI-guided core-needle biopsy and PSA recording (for NCCN group label).
  3. Signed informed consent prior to initiation of any study-related procedures.
  4. The patient provided a voided urine sample within 30 days prior to biopsy being performed and prior to DRE (if any). This collection must be ≥ 1 hour after the last urination.

Exclusion Criteria:

  1. Persons previously diagnosed with prostate cancer.
  2. Persons who have previously undergone a 12 core or fusion biopsy in the last 12 months
  3. Persons who have had a DRE within 72 hours of the urine collection
  4. Persons incapable of providing informed consent.
  5. Persons presenting with clinical symptoms of urinary tract infection, including prostatitis at the time of enrollment.
  6. Persons with prior history of invasive treatment for benign prostatic hyperplasia within 3-6 months of study enrollment.
  7. Patients treated with a 5-alpha-reductase inhibitor, Saw Palmetto for BPH or male pattern baldness within 3 months of the urine collection.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Using Breath,Cell Free DNA and Image Analysis to PRedIct Normal TissUe and Tumour Response During Prostate Cancer SBRT With RayPilot® Motion Management


Condition: Prostate Cancer, Radiotherapy Side Effects, Volatile Organic Compounds, DNA Damage

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT04081428

Sponsor: NHS Lothian

Phase:

Eligibility:

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

Inclusion Criteria:

  • Low risk prostate cancer T1-2, PSA<10ng/ml, Gleason score (GS) 3+3=6
  • Intermediate risk prostate cancer T1-T2, PSA 10-20ng/ml,GS ≤7(3+4=7 only)
  • World Health Organisation (WHO) performance status 0-2
  • Prostate volume ≤90cc
  • International Prostate Symptom Score (IPSS) ≤20
  • Peak urinary flow rate (Q-max) >10cc/sec
  • Urinary residual <250mls total
  • No prior Trans Urethral Resection of the Prostate (TURP)
  • No previous pelvic radiotherapy
  • Able to give informed consent
  • Aged between 18-85 years of age

Exclusion Criteria:

  • Inflammatory bowel disease
  • Previous androgen deprivation therapy
  • History of urinary retention

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)


Condition: Prostate Cancer, PSA, Infection

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04081636

Sponsor: Albany Medical College

Eligibility:

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

Inclusion Criteria:

  • All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
  • Either with or without an MRI

Exclusion Criteria:

  • Patients with no access to rectum (due to previous rectal surgery)
  • Any abnormalities of the perineal skin (e.g. infection)
  • Patients whose procedure requires sedation or general anesthesia

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Prostate Cancer Patients Treated With Alternative Radiation Oncology Strategies


Condition: Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04083937

Sponsor: University Hospital Heidelberg

Eligibility:

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

Inclusion Criteria:

  • histology-proven prostate cancer with Gleason Score and PSA-value;
  • indication for prostate bed irradiation (adjuvant/ salvage) after prostatectomy;
  • Karnofsky-Index ≥ 70%
  • age ≥ 18 years

Exclusion Criteria:

  • androgen deprivation therapy
  • lymphatic spread
  • macroscopic tumor/ R2
  • stage IV (M1)
  • previous irradiation

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

CELLO-1: A Phase 1b/2 Open-Label Study Evaluating Tazemetostat in Combination With Enzalutamide or Abiraterone/Prednisone in Chemotherapy Naive Subjects With Metastatic Castration-Resistant Prostate Cancer


Condition: Metastatic Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04179864

Sponsor: Epizyme, Inc.

Phase: Phase 1/Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Age at the time of consent ≥ 18 years. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 (Appendix 3. Life expectancy of > 3 months. 4. Histologically or cytologically confirmed adenocarcinoma of the prostate. Small cell or neuroendocrine tumors of the prostate are also permitted. 5. Progressive disease in the setting of medical or surgical castration (ie, castration- resistant prostate cancer [CRPC]) by PCWG3 criteria for study entry.
  • Evidence of disease progression by rising PSA or
  • Soft tissue progression per RECIST 1.1 or
  • Evidence of disease progression by observation of 2 new bone lesions since the initiation of last systemic therapy. 6. Metastatic prostate cancer disease, documented by the following imaging • Bone lesions on bone scan (per PCWG3) or by soft tissue disease (per RECIST 1.1) by CT/MRI imaging Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist. 7. Prior treatment with a second-generation androgen inhibitor as follows:
  • For phase 1b, EITHER Previously untreated with or progressed on a second generation androgen inhibitor (abiraterone, enzalutamide, or apalutamide) OR progressed on a second generation inhibitor (inhibitor (abiraterone, enzalutamide, or apalutamide)
  • For phase 2 randomized component (i.e, enzalutamide- containing treatment arms) of the study, previously progressed on abiraterone.

Exclusion Criteria:

  • 1. Known symptomatic brain metastases 2. Treatment with any of the following for prostate cancer within the indicated timeframe prior to day 1 of starting study treatment:
  • First generation: AR antagonists (eg, bicalutamide, nilutamide, flutamide) within 4 weeks.
  • 5-alpha-reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol), or progesterones within 2 weeks.
  • Chemotherapy (except as permitted in inclusion criteria #10) within 3 weeks.
  • Prior radionuclide therapy within 4 weeks.
  • Another interventional product or standard agent in a clinical study within 28 days prior to the first planned dose of Tazemetostat
  • For phase 2 subjects to be randomized to one of the enzalutamide treatment arms only, prior treatment with the second-generation androgen antagonist including enzalutamide, apalutamide, darolutamide, and proxalutamide, etc. 3. Severe concurrent disease, infection, or comorbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment 4. Has had prior exposure to tazemetostat or other inhibitor(s) of enhancer of zeste homologue-2.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Fluciclovine (FACBC) PET/CT Site-Directed Therapy of Oligometastatic Prostate Cancer (Flu-BLAST-PC)


Condition: Prostate Adenocarcinoma, PSA Level Greater Than or Equal to 0.5, PSA Level Less Than Ten

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT04175431

Sponsor: University of Washington

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • Patient must have histologically or cytologically documented evidence of prostate adenocarcinoma
  • Patient must previously have undergone radical prostatectomy
  • Patient must previously have undergone either adjuvant or salvage radiation therapy to the prostatic fossa +/- whole pelvis
  • PSA doubling time must be calculated utilizing all PSA measurements from most recent biochemically-recurred (BCR). PSA doubling time must be > 3 months and < 18 months. The Memorial Sloan Kettering PSA doubling time calculator should be used
  • Patient must have no previous evidence of radiographically detectable metastatic prostate cancer by conventional CT and bone scan imaging
  • Patient must have total testosterone level > 120 ng/dL demonstrated within 28 days of enrollment
  • Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Absolute neutrophil count (ANC) >= 1.0 X 10^9/L
  • Platelet count >= 100 X 10^9/L
  • Hemoglobin >= 9 g/dL
  • Potassium >= 3.5
  • Serum bilirubin =< 1.5 X upper limit of normal (ULN) or =< 3 X ULN for patients with documented Gilbert's syndrome
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 X ULN
  • Creatinine clearance (Cr Cl) >= 30 mL/min as estimated by the Cockcroft-Gault criteria or as determined by 24 hour Cr Cl measurement
  • Patient must be able to understand and authorize informed consent

Exclusion Criteria:

  • Chronic active hepatitis B or C
  • History of a second, non-prostate malignancy that required systemic therapy in the last 2 years except cancer in situ of bladder and non-melanomatous cancers of the skin
  • Patient with a serious underlying medical condition that would otherwise impair the patient's ability to undergo fluciclovine PET/CT imaging or receive subsequent treatment
  • Any condition that would alter the patient's mental status, prohibiting understanding and/or authorization of informed consent
  • Expected lifespan of less than 12 weeks
  • Inability to lay still for imaging
  • Weight > 300 lbs. (due to equipment specifications)
  • Any other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and/or follow up

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
{{header-clinical-trials-navigation}}

Phase II, Open-label, Single-center Study Evaluating Safety and Activity of Androgen Deprivation Therapy Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer (mHSPC)


Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03951831

Sponsor: Mark Stein

Phase: Phase 2

Eligibility:

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

Inclusion Criteria:

  • 1. Be willing and able to provide written informed consent for the trial. 2. Age ≥18 years of age on day of signing informed consent. 3. Have life expectancy > 12 months. 4. Have a performance status of 0 or 1 using the Eastern Cooperative Oncology Group (ECOG) Performance Scale. 5. Have histologically or cytologically confirmed prostate cancer from prostate biopsy, radical prostatectomy, TURP or from biopsy of a metastatic site. Rarely pathology is not available but if clinical situation confirms prostate cancer (such as prior response to androgen ablation and/or metastatic disease typical of prostate cancer, i.e. involving bone or pelvic/extra pelvic lymph nodes or para-aortic lymph nodes, AND an elevated serum concentration of PSA typical of prostate cancer) pathology is not required and patient can be enrolled after discussed with study PI.. 6. Have metastatic disease that is either measurable or evaluable (non-measurable). 7. Have evaluable (non-measurable) or measurable disease, based on RECIST 1.1, with at least one lesion amenable to biopsy. 8. Have testosterone level ≥ 150ng/dL. 9. Have not been on androgen deprivation therapy or novel hormonal agents (e.g., abiraterone, enzalutamide, apalutamide) for at least 6 months prior to enrollment in trial and must not have exceeded 24 months of therapy 10. Have not received any adjuvant or neoadjuvant chemotherapy or immunotherapy. 11. Have not had prior bilateral surgical orchiectomy. 12. Have not received palliative radiation within 14 days of starting ADT on study treatment. 13. Have adequate organ and marrow function as defined below:
  • Leukocytes ≥3,000/microliters (mcL)
  • Absolute Neutrophil Count ≥1,500/mcL
  • Platelets ≥100,000
  • Hemoglobin ≥ 8.0g/dL (without transfusion in past 2 weeks)
  • Prothrombin time (PT)/international normalized ratio (INR), partial thromboplastin time (PTT) ≤ 1.5 upper limit of normal (ULN) (except if on therapeutic anticoagulation in which case the patient can be enrolled if stable and anti-coagulation levels are appropriate for their condition per good clinical practice).
  • Aspartate aminotransferase (AST)(SGOT)/ alanine aminotransferase (ALT)(SGPT) ≤2.5 × institutional ULN
  • Total bilirubin within normal institutional limits. Note: Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g. Gilbert's syndrome) will be eligible at the discretion of the treating physician and/or the principal investigator.
  • Creatinine clearance of ≥ 30 mL/min. Creatinine clearance (CrCl) should be calculated at screening using the Cockcroft-Gault formula. 14. Agree to undergo serial tumor biopsies, unless medically contraindicated in the opinion of the treating physician, and discussed with the principal investigator 15. The effects of REGN2810 on the developing human fetus are unknown. For this reason and because REGN2810 agents [as well as other therapeutic agents used in this trial] are known to be teratogenic, 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 REGN2810 administration. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

  1. The subject must be excluded from participating in the trial if the subject:
  2. Received ADT or other hormonal agents within 6 months prior to entering the study or in the metastatic setting with the exception of 5-alpha reductase inhibitors (e.g. finasteride and dutasteride) and first-generation androgen receptor inhibitor (e.g. bicalutamide) in setting of normal testosterone. Advise subject to continue the 5-alpha reductase inhibitor for the duration of the study if already started. Advise subject to stop the androgen receptor inhibitor for duration of the study
  3. Received prior immunotherapy (including inhibitors of programmed cell death protein 1 (anti-PD-1), anti-PD-L1, anti-CTLA4, or Sipuleucel-T).
  4. Received prior chemotherapy for prostate cancer treatment.
  5. Received radiation within 2 weeks prior to entering study.
  6. Is receiving any other investigational agents concurrently.
  7. Had a solid organ or hematologic transplant.
  8. Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  9. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  10. Has a diagnosed malignant disease, other than the tumor type being treated in this study. Note: Patients with a prior or concurrent malignancy of low metastatic potential that does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen may be included (e.g., patients with a history of nonmelanoma skin cancer, carcinoma in situ of the cervix, early stage cancers treated with curative intent, non-muscle invasive bladder cancer, stage I renal cancer)Has a known history of, or any evidence of, interstitial lung disease or active noninfectious pneumonitis.
  11. Peripheral neuropathy must be ≤ grade 1
  12. Has an active infection requiring systemic therapy.
  13. Has a history of current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator, including dialysis.
  14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  15. Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). Note: HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with REGN28
  16. In addition, these patients are at increased risk of lethal infections when treated with immunotherapy and marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
  17. Has untreated active Hepatitis B. Note: To qualify for enrollment, antiviral therapy for HBV must be given for at least 3 months, and HBV viral load must be less than 100 IU/mL prior to first dose of study drug. Those on active HBV therapy with viral loads under 100 IU/mL should stay on the same therapy throughout trial treatment. Those subjects who are anti-HBc (+), and negative for HBsAg, and negative for anti-HBs, and have an HBV viral load under 100 IU/mL do not require HBV anti-viral prophylaxis, but need close monitoring.
  18. Has dual infection with HBV/HCV or other hepatitis combinations at study entry.
  19. Has received a live vaccine within 30 days of planned start of study therapy (Cycle 1, Day 1). Note: The killed virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  20. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded.

View trial on ClinicalTrials.gov


{{footer-clinical-trials-navigation}}
email news signup