Subjects on bisphosphonates for any cancer or on hormone therapy for prostate cancer may continue this therapy. However, subjects with prostate cancer must have confirmed metastatic disease that has progressed despite hormonal therapy producing castrate levels of testosterone.
Treatment with any of the following for prostate cancer within 4 weeks prior to day 1 of treatment:
Saw palmetto or other therapies thought to have endocrine effects on prostate cancer
Prostate cancer patients must have received and progressed on enzalutamide
Evidence of prostate cancer progression by any of the following criteria: radiographic or PSA criteria, or symptomatic progression related to prostate cancer
Histologic confirmation of original prostate cancer diagnosis per institutional standard; life expectancy of greater than 6 months
Solid tumors measurable according to RECIST 1.1 or solid tumors not measurable according to RECIST 1.1, but which express tumor markers (e.g., prostate cancer with prostate specific antigen (PSA) expression or ovarian cancer with cancer antigen-125 (CA-125) expression) are eligible.
Prior systemic chemotherapy for prostate cancer.
Prior use of ketoconazole for the purposes of prostate cancer therapy
Prior chemotherapy for prostate cancer (upfront, adjuvant, etc.) is allowed as long as it was not given for hormone-refractory disease
Asymptomatic or mildly symptomatic form of prostate cancer
Confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer
Prostatic intraepithelial neoplasia without evidence of prostate cancer
Prostate cancer is diagnosed by MR image guided biopsies
History of prior treatment for prostate cancer.
Low-grade prostate cancer
Decision to manage prostate cancer with active surveillance
Prior systemic chemotherapy for prostate cancer.
Prior systemic chemotherapy for prostate cancer
Prior ADT with GnRH analogue for prostate cancer for more than 2 weeks
Asymptomatic or mildly symptomatic form prostate cancer; no use of regularly scheduled opiate analgesics for prostate cancer-related pain; (patients with a malignancy other than prostate cancer are excluded from this criterion)
No previous local therapy for prostate cancer
Prostate deemed resectable by surgeon
Previous local therapy for prostate cancer
Previous chemotherapy for prostate cancer
Prior radiation therapy to the prostate or lower pelvis encompassing the prostate
Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy.
Measurable disease, with the exception of prostate cancer
If had prior definitive radiation therapy to the prostate: no evidence of locally persistent or recurrent prostate cancer on digital rectal exam (DRE) and imaging studies (CT or MRI)
Prior radiation to the prostate
Histologic diagnosis of prostate cancer identifying Gleason score of 3+4 on one half of the prostate gland in no more than 2 sextants of the prostate gland and not present in more than 50% of any one core taken systematically. The involvement criterion does not apply to cores taken from MRI suspicious volumes.
Prostate cancer stage up to cT2a - N0/Nx - M0/Mx.
Prostate volume ?25 mL and ?70 mL.
Subjects receiving any treatment other than AS for prostate cancer.
Patients who have had any prior chemotherapy or radiotherapy for prostate cancer.
Patients with known metastatic prostate cancer.
Any prior treatment for castration-resistant prostate cancer (CRPC) with carboplatin, cisplatin, cabazitaxel or olaparib.
Subjects must have measurable disease (RECIST v 1.1) or patients may have bone metastatic disease evaluable by Prostate Cancer Working Group 2 (PCWG2) for subjects with metastatic castration-resistant prostate cancer (CRPC) or according to tumor evaluation criteria best suitable and accepted for the tumor type evaluated.
Patients with a current diagnosis of prostate cancer will be excluded
Patients with high-risk prostate cancer (at least 1 core with Gleason sum >= 8) must have at least three core biopsies involved with cancer (a minimum of 6 core biopsies, must be obtained at baseline). A prostate biopsy within 3 months from screening is allowed for entry requirements.
Ongoing hormonal therapy administered for control of cancer (e.g., breast cancer, prostate cancer), which may be continued throughout the study
Prostate size ? 50 cc
Asymptomatic or mildly symptomatic from prostate cancer
No treatment with any of the following for prostate cancer within 4 weeks prior to enrollment:
No prior chemotherapy for prostate cancer
Prior immunotherapy or chemotherapy for prostate cancer
Histologically confirmed diagnosis of prostate cancer; histologic variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate are included; if neuroendocrine prostate cancer is not biopsy proven, clinical evidence of neuroendocrine prostate cancer is acceptable for stratification into group A
Prostatic intraepithelial neoplasia without evidence of prostate cancer.
Metastatic prostate cancer
Prior immunotherapy/vaccine therapy for prostate cancer
Patients who have had prior chemotherapy for prostate cancer
Very low risk and low risk groups will be confirmed by Oncotype DX prostate cancer test and provided a genomic prostate score (GPS)
Prior history of treated prostate cancer
Prostate volume greater than 80 cc on transrectal ultrasound
Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.
Asymptomatic or minimally symptomatic (not requiring opioids for cancer related pain) metastatic castration-resistant prostate cancer (CRPC) patients on abiraterone as standard of care and achieved at least 50% decline of their pre-treatment PSA
Prior cabazitaxel or radium 233 for prostate cancer
Previously treated with ketoconazole for prostate cancer for greater than 7 days
Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer
Prior systemic chemotherapy for prostate cancer
Any patient with clinically localized, histologically proven adenocarcinoma of prostate who has not received any treatment for prostate cancer ever and has chosen active surveillance; treatment for prostate cancer is defined as prostatectomy, androgen deprivation, brachytherapy or a full course of external beam irradiation
Prior or current therapy for prostate cancer
Asymptomatic patients with non-metastatic, biochemical progression of prostate cancer
Advanced prostate cancer
Previous or current hormonal management of prostate cancer (unless terminated at least 12 months prior to trial)
Prostate cancer
Patients with pathologically?confirmed N1 prostate cancer
Men with metastatic, castration resistant prostate cancer involving the bone, which is symptomatic or asymptomatic
Asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC)
Prior chemotherapy for castration resistant prostate cancer; neoadjuvant chemotherapy and chemotherapy given for hormone sensitive prostate cancer are allowed
Prostate cysts or prostate calcifications > 1 cm on ultrasound
No prior treatment for prostate cancer
Prostate cancer clinical stage T2a and below
Prostate size < 60 cc on transrectal ultrasound
Prior radiation therapy to prostate or prostate bed is allowed provided it occurred > 3 months before enrollment to the study
Patients with prior chemotherapy given for castrate-resistant prostate cancer
Prior chemotherapy for prostate cancer
Has had a prior radium treatment or treatment with other therapeutic radiopharmaceuticals for prostate cancer
For Cohort C: Has a history of prostate cancer progression on ketoconazole
Prior systemic biologic therapy, including immunotherapy, for prostate cancer;
Prostate volume ? 90 cc, on Baseline MRI
Prior definitive treatment of prostate cancer
Previous chemotherapy unless intervention was greater than 5 years from beginning treatment for prostate cancer
Subject has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
Prior chemotherapy or immunotherapy for prostate cancer.
Asymptomatic prostate cancer;
Prostatic intraepithelial neoplasia without evidence of prostate cancer
Prior use of immunotherapy or chemotherapy for prostate cancer
Prior radiation therapy for prostate cancer
Prior investigational therapy for prostate cancer
Patients must have progressive, metastatic, castration-resistant prostate cancer (mCRPC) as defined below:
Any previous ablative procedures performed on the prostate, e.g., electroporation, radiofrequency ablation, high-intensity focused ultrasound (HIFU), cryosurgery, photochemical, thermal or microwave therapy to treat cancer of the prostate.
Metastatic, castrate resistant prostate cancer (M1 by National Comprehensive Cancer Network (NCCN) criteria)
Previous surgery for prostate cancer
Patients must have metastatic prostate cancer (clinical stage D1 or D2 disease), with previously documented lymph node, soft tissue and/or bone metastases by radiographic imaging (including computed tomography [CT] [or magnetic resonance imaging (MRI)] of abdomen and pelvis and bone scintigraphy); patients in situations in which there is a reasonable clinical suspicion of a second primary tumor (or other non-prostate cancer reason for radiographic abnormalities) are not eligible unless metastatic disease is histologically confirmed to be prostate cancer
Have an active malignancy other than prostate cancer that requires therapy
Prostate gland volume should be no greater than 70 cc, volumetrically measured.
History of orchiectomy, PCa-specific chemotherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy.
Prostate size > 140 cc or pubic arch interference study demonstrating unacceptable prostate access by the transperineal approach
Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
Patient may have had prior systemic therapy and/or ADT associated with treatment of their primary prostate cancer; patient may have had ADT associated with salvage radiation therapy (to the primary prostate cancer or pelvis is allowed)
Castration-resistant prostate cancer (CRPC)
Prior salvage treatment to the primary prostate cancer or pelvis is allowed
No prior systemic therapy for metastatic prostate cancer
Received prior therapeutic intervention for metastatic prostate cancer
Prior ADT for prostate cancer (including bilateral orchidectomy), except in the following settings:
Participation in other clinical trials of investigational agents for the treatment of prostate cancer or other diseases.
Additionally, patients will be required to meet the following criteria \r\n* Karnofsky performance status (KPS) >= 70\r\n* Prostate volume =< 60 cc (cytoreductive androgen deprivation therapy prior to brachytherapy of =< 6 months duration will be allowed to achieve this goal); for patients with a prostate volume between 50-60 ccs, hormone therapy will be at the discretion of the physician\r\n* International Prostate Symptom Score =< 15
Previously treated with ketoconazole for prostate cancer for greater than 7 days
Patients diagnosed with prostate cancer that elect to undergo primary cryotherapy of the prostate
Prostate cancer progression
Subjects must have metastatic prostate cancer mass tissue collection within 3 months of study entry
Have pathologic diagnosis of prostate cancer
History of prostate cancer progression of ketoconazole
Prostate cancer progression documented by prostate specific antigen according to the Prostate Cancer Working Group 2 (PCWG2) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
Asymptomatic or mildly symptomatic prostate cancer.
Treatment with more than one chemotherapy agent for prostate cancer
Stage T4 prostate cancer by clinical examination or radiologic evaluation
COHORT A: Current or prior investigational therapies for prostate cancer, or chemotherapy administered with the intention to treat prostate cancer
COHORT B: Current or prior investigational therapies for prostate cancer, or chemotherapy administered with the intention to treat prostate cancer
Men with metastatic castration-resistant prostate cancer
More than 2 prior courses of chemotherapy for metastatic prostate cancer
Previous use of immunotherapy or radium-223 for the treatment of metastatic prostate cancer
Asymptomatic or mildly symptomatic from prostate cancer
Previous treatment with ketoconazole for prostate cancer for greater than 7 days
Prior treatment with radiopharmaceutical agents, or any other investigational agent for non-metastatic castration-resistant prostate cancer
Previously treated with ketoconazole for prostate cancer for greater than 7 days
Prior radiotherapy to the prostate or pelvis (related to prostate cancer); concurrent adjuvant radiation therapy is permitted once patient has been enrolled on trial
Asymptomatic or mildly symptomatic from prostate cancer; no use of regularly scheduled opiate analgesics for prostate cancer-related pain
Patients with prior chemotherapy for nonmetastatic prostate cancer within a year are excluded
No prior radiation or chemotherapy for prostate cancer treatment
Clinical evidence of metastatic prostate cancer
History of progression of prostate cancer while receiving ketoconazole
The subject has received chemotherapy for castration-resistant prostate cancer
Have a histologic or cytologic diagnosis of prostate cancer
Patients must not have been treated with a prior vaccine therapy for prostate cancer
E 01. Prior chemotherapy for prostate cancer,
Biopsy-proven (consisting of >= 10 tissue cores) adenocarcinoma of the prostate diagnosed within 24 months prior to pre-registration            \r\n* < 25% of biopsy tissue cores positive for cancer\r\n* =< 50% of any one biopsy tissue core positive for cancer\r\n* Clinical stage =< T2a\r\n* Patients who have prostate cancer with distant metastases are not eligible\r\nNOTE: if a patient undergoes a transurethral resection of the prostate (TURP) for benign prostatic hyperplasia (BPH), and prostate cancer is diagnosed incidentally from the TURP specimen, eligibility for CALGB 70807 cannot be determined from the TURP specimen; however, if the patient subsequently undergoes a minimum 10-core prostate biopsy within 2 years of prostate cancer diagnosis from the TURP, and prostate cancer is detected in the biopsy specimen and meets the requirements above, the patient is eligible for this study; if prostate cancer is not detected in the biopsy specimen, the patient is not eligible
Asymptomatic or mildly symptomatic from prostate cancer
prostate biopsy with ?10 core biopsies demonstrating 1 or more cores positive for cancer cells, within 6 months prior to treatment;
prostate volume ? 40 gms(cc) (HIFU subject prostate volume will be initially calculated utilizing TRUS measurements during screening and verified with the use of the Sonablate before initiating the HIFU procedure. Patients with prostate volumes greater than 40 gm(cc) as determined by either measurement will not be enrolled in the study);
prior treatment for prostate cancer, other than EBRT or hormone therapy;
prostate seroma/abscess;
Metastatic asymptomatic or minimally symptomatic castration-resistant prostate cancer (CRPC) patients who are eligible for sipuleucel-T
asymptomatic prostate cancer without known metastatic disease and with no current requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for ? 1 year prior to enrollment, or
If < 3 cores then at least one prostate core must contain >= 30% prostate cancer
Have a confirmed diagnosis of prostate cancer
localized prostate cancer
No other systemic therapies for prostate cancer within 28 days prior to initiation of this protocol
No history of radiopharmaceuticals (strontium, samarium) for prostate cancer treatment
Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ? 8 weeks prior to screening
No treatment for prostate cancer has been administered or will be administered before TRUS guided biopsy
Histologically confirmed adenocarcinoma of the prostate\r\n* In situations where pathology reports documenting prostate cancer are no longer available such as when the initial biopsy or prostatectomy was performed in the remote past, a documented history of prior prostate cancer and prostate cancer treatment in prior medical records will be sufficient
Metastatic prostate carcinoma and at least one of the following:
Patients with known evidence of active cancers, or other cancer under active treatment; exceptions include patients with no evidence of disease receiving adjuvant hormone-based therapy or either breast or prostate cancer
Patients may not have received any prior pharmacologic therapy or RT for prostate cancer
Prostate cancer with the following pathological characteristics:\r\n* Gleason sum >= 8 AND at least 2 discrete core biopsies containing a minimum of 20% cancer OR\r\n* Gleason pattern 4 + 3 = 7 AND greater than 50% of biopsies positive for prostate cancer
Up to 6 patients with castration-resistant prostate cancer (CRPC) that was pathologically confirmed as adenocarcinoma of the prostate and with evidence of metastatic disease on bone scan or other imaging. Patient must have progressive disease after at least one hormonal treatment and one cytotoxic therapy e.g. with docetaxel, mitoxantrone.
Patients who have had chemotherapy for metastatic castration-resistant prostate cancer
Prior ketoconazole for prostate cancer
Prior chemotherapy for prostate cancer
Metastatic castration-resistant prostate cancer (CRPC)
Prior ketoconazole for prostate cancer
Primary diagnosis of prostate cancer selected for surgical intervention by one of the six protocol surgeons (Chapin, Davis, Matin, Pettaway, Pisters, Ward)
Have had prior or current prostate cancer therapies:
Biologic therapy for prostate cancer
Chemotherapy for prostate cancer
Radiotherapy for prostate cancer,
Prior chemotherapy for prostate cancer
Past history of prostate cancer or non-Hodgkin’s lymphoma with only active surveillance (i.e., no surgery, chemotherapy, or radiation therapy)
Patient has a primary diagnosis of localized prostate cancer (T1; T2, N=0 M=0; T3, N=0, M=0)
Patient has had previous definitive treatment for localized prostate cancer
Must be diagnosed with prostate cancer and on active surveillance within the past 36 months (or the spouse or significant other of someone with prostate cancer on active surveillance)\r\n* While AS criteria for each program varies slightly, all programs use the following clinical and pathological criteria:\r\n** Clinical stage T1c or T2a prostate cancer, verified by a participating urologist\r\n** Diagnosis of prostate cancer made on a 12 core needle biopsy (if any of this information was unavailable prior to consent or on the diagnostic biopsy report, the eligibility was contingent on either urologist review of the diagnostic biopsy or the pathological data from the confirmation biopsy)\r\n** Biopsy Gleason score =< 6 OR Gleason score 7 (3+4 ONLY), with =< 3 cores positive
Have pursued any active therapy for prostate cancer will be excluded.
Subjects may have received up to one or two doses of their planned chemotherapy prior to enrollment; otherwise the restrictions for prior therapy:\r\n* Breast cancer subjects may have received curative-intent chemotherapy for a separate malignancy more than 3 years ago\r\n* Prostate cancer subjects may have received prior treatment with metronomic cyclophosphamide as this is considered anti-angiogenic/immunomodulatory and not cytotoxic\r\n* Prostate cancer subjects may be receiving a 2nd course of docetaxel provided that \r\n** The first course resulted in a prostate specific antigen (PSA) response (> 30% reduction in PSA and/or improvement in radiographic findings or pain) and the last dose was >= 9 months ago
Men with a new histologic diagnosis of localized prostate cancer
Individuals with a medical condition that necessitates a specific prostate cancer treatment plan
Prior chemotherapy, radiation therapy for the treatment of prostate cancer, or immunotherapy for prostate cancer
Metastatic prostate cancer (hormone-sensitive, de novo, or castration resistant)
Prostate cancer diagnosed at age =< 55 years
Prostate cancer diagnosis and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age =< 50, ovarian, pancreatic, uterine, colorectal, prostate cancer or sarcoma, in one or more first or second degree relatives)
Localized prostate cancer previously treated and in remission for >= 2 years
PROSTATE CANCER COHORT:
Any active malignancies being treated other than bladder cancer (incidentally found prostate cancer at RC is acceptable).
Men who do not reside in one of the four neighborhoods, who self-report that they have previously been diagnosed with prostate cancer, or who have had prostate cancer screening (prostatic specific antigen [PSA] or digital rectal examination [DRE]) within the past 12 months
Patients with prostate cancer
Diagnosed with prostate cancer
Not diagnosed with prostate cancer
Not receiving or planning to receive ADT for prostate cancer treatment within the last three months
Initiating ADT for prostate cancer prior to the previous 3 months or are not on ADT holiday
Diagnosis of prostate cancer
Diagnosis of prostate cancer
Has been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
Has no other active primary malignancy aside from prostate cancer
Has NOT been diagnosed with localized prostate cancer (i.e. pathologically and/or radiographically confirmed)
Has other active primary malignancy aside from prostate cancer
Any prior chemotherapy for castrate-resistant prostate cancer
Previous prostate surgery
PROSTATE CANCER: Histologically confirmed prostate cancer
Any prior or concurrent treatment for prostate cancer
Asymptomatic, or minimally symptomatic from prostate cancer or prostate cancer related therapies\r\n* No opioid-requiring cancer related pain \r\n* Any therapy related genitourinary or gastrointestinal symptoms should be considered as mild (Common Terminology Criteria for Adverse Events [CTCAE] grade 1 or 2) and not interfering with activities of daily living
Subjects without a diagnosis of prostate cancer.
Prior surgery or radiation therapy for prostate cancer
Have non-metastatic prostate cancer and =< clinical T3a disease at diagnosis
Receiving hormonal therapy for prostate cancer
Metastatic, castrate resistant, histologically confirmed prostate cancer; surgically castrated or continuous medical castration for ? 8 weeks prior to screening
urothelial, SCHNN, prostate, soft tissue sarcoma, prostate cancer, TNBC, ccRCC, NSCLC: 1-5 prior treatments
Having completed definite treatment of localized prostate cancer (surgery or radiation)
Prostate cancer (PCa) diagnosis
History of prior prostate biopsy in the last 5 years
Prior diagnosis of prostate cancer
Arm 1 patients must have treatment-naive, Gleason >= 7 prostate cancer based on transrectal ultrasound (TRUS) or prostate mapping biopsy, have localized disease, and have decided to undergo radical prostatectomy (open or robotic) as definitive treatment for their prostate cancer
Men who will be undergoing transrectal ultrasound of the prostate with biopsy for the evaluation of prostate cancer in the Division of Urology at City of Hope, or at participating urology clinics
Men with a previous diagnosis of prostate cancer
Men without a prior diagnosis of prostate cancer but who have previously undergone a biopsy for a suspicious DRE or PSA
Risk of prostate cancer 20-60% calculated with the on-line PCPT prostate cancer risk calculator; PSA value must be obtained within 3 months prior to study entry
Prior history of prostate cancer
Diagnosed with prostate cancer
Have a prostate cancer diagnosis
Diagnostic prostate biopsy with only 1 core with cancer and < 5% of tissue from that core involved with cancer
Castration-resistant prostate cancer
No concurrent treatment (hormonal, radiation or systemic chemotherapy) for prostate cancer during study enrollment is planned (unless participants demonstrate clinical evidence of prostate cancer progression such as symptoms, physical exam findings, a rapidly increasing PSA, or radiologic findings which confirm disease progression)
Subjects with a prostate volume of >80mL
Current investigational therapy for prostate cancer
SUB-STUDY I: Chemotherapy for prostate cancer
SUB-STUDY II: Chemotherapy for prostate cancer
SUB-STUDY III: Investigational therapy for prostate cancer less than 28 days prior to study PET imaging
Men with prostate cancer and known bone metastases planned for new systemic therapy and/or radiotherapy and who have a planned clinically indicated staging multi-detector computed tomography (MDCT)
Histological diagnosis of adenocarcinoma of the prostate OR has a clinical diagnosis of prostate cancer and on active therapy or has received treatment for prostate cancer
Suspected prostate cancer based on elevated PSA level (>= 4) and abnormal digital rectal examination with clinical decision to proceed to prostate biopsy
Have an active malignancy other than prostate cancer that requires therapy
Patient must not have had any prior treatment for prostate cancer
Prostate volume 20 - 100 cc
Chemotherapy for prostate cancer
Investigational therapy for prostate cancer
The patient must have either 1) an established diagnosis of pancreatic cancer by biopsy or 2) cancer involving the liver by biopsy or radiographic criteria, or 3) prostate cancer by biopsy, with the intent of undergoing definitive dose radiation therapy to targets within the pancreas, liver, or prostate; patients with prostatectomy receiving post-operative radiotherapy are also eligible
INCLUSION CRITERIA (NEXT 60 PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Histological confirmation of prostate cancer
Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
Males scheduled for prostate biopsy (for known or suspected prostate cancer) followed by planned prostatectomy (population group A), or
Plan to undergo external radiation treatment of prostate cancer
Patients who have had chemotherapy or radiotherapy within 12 months of the study for other diagnoses not related to prostate cancer
Investigational therapy for prostate cancer
Minimum 10 core prostate biopsy showing histologically-confirmed prostate cancer within 12 months of enrollment reviewed by a pathologist from one of the Dana Farber (DF)/Harvard Cancer Center (HCC) associated hospitals
First diagnosis of prostate cancer > 12 months prior to enrollment
Patient is diagnosed with >= stage 3 breast cancer or >= stage 2 prostate cancer (and/or prostate-specific antigen [PSA] > 10 micrograms/L), including patient with recurrent breast or prostate cancer
Subject must be scheduled for a clinically indicated needle biopsy of the prostate based upon an elevated prostate specific antigen (PSA), abnormal digital rectal examination, or based upon active surveillance of prostate cancer
Previous treatment for prostate cancer (PCa)
Investigational therapy for prostate cancer
Known prostate cancer with a clinical concern for the presence of metastatic disease as delineated below:\r\n* Population 1: treatment naive patients with one of the following risk factors: Cancer of the Prostate Risk Assessment (CAPRA) score >= 5, PSA >= 15 ng/mL and/or Gleason score >= 4+4\r\n* Population 2: patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than 12 months\r\n**These patients may have received androgen deprivation therapy prior to imaging\r\n* Population 3: patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Working Group 2 (PCWG2) criteria \r\n** Patients with castrate resistant prostate cancer can be either on treatment or off treatment
Prostate biopsy must be reviewed at Brigham and Women’s Hospital or the Dana Farber Cancer Institute and should support a diagnosis of stage I-III prostate adenocarcinoma
Known diagnosis of prostate cancer
No prior treatment for prostate cancer
Minimal tumor burden as defined by at least one of the following criteria:            \r\n* One single core with >= 50% cancer burden and >= 5 mm tumor length\r\n* Two or more cores in the same prostate region, each with >= 30% cancer burden\r\n* Three or more cores positive for prostate cancer (of any magnitude of cancer burden) in the same prostate region\r\n* Gleason score of 7 or higher cancer burden\r\n* Prostate-specific antigen (PSA) >= 10 ng/mL
Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer
A diagnosis of prostate adenocarcinoma on more than one set of prostate biopsies, on separate calendar dates
ARM I ONLY: For patients with presumed localized disease (any T, N0, M0), a multiparametric MRI (standard of care at the National Institutes of Health [NIH] Clinical Center) must be performed within 4 months of the 18F-DCFBC injection with findings suggestive for prostate cancer and a prostate lesion at least 6 mm or greater; must have histopathologic confirmation of prostate cancer prior to 18F-DCFBC imaging
Disease status: unfavorable intermediate to high-risk prostate cancer, Cancer of the Prostate Risk Assessment Score (CAPRA 5-10)
Men at least 18 years of age referred with clinical suspicion of prostate cancer who have been advised to have a prostate biopsy
Prior treatment for prostate cancer
Subjects with clinically localized prostate cancer (outside pathology is acceptable) must have image guided biopsy confirmed prostate cancer and sufficient tissue available (obtained before or after 20 weeks of Eovist® injection) for OATP1B3 expression
Men with prostate cancer who elect surgery as the primary treatment of their cancer and to be performed at the Moffitt Cancer Center
Biopsy confirmed prostate cancer with at least ten biopsies performed for diagnosis
Known diagnosis of prostate cancer
Known prostate cancer
Any prostate size
History of prostate cancer
Patients preparing to receive systemic therapy to treat metastatic castration-resistant prostate cancer
Minimally-symptomatic or asymptomatic, castrate-resistant metastatic prostate cancer, as evidenced by all of the following:\r\n* Histologically-confirmed diagnosis of adenocarcinoma of the prostate\r\n* Evidence of adequate androgen deprivation, as evidence by one of the following:\r\n** Bilateral orchiectomy\r\n** Ongoing luteinizing hormone-releasing hormone (LHRH) agonist (e.g. leuprolide, goserelin) and serum testosterone =< 50 ng/dl\r\n** Ongoing LHRH antagonist (e.g. degarelix) and serum testosterone =< 50 ng/dl\r\n* Evidence of prostate cancer resistance to castration, as evidenced by at least one of the following:\r\n** 2 consecutive prostate-specific antigen (PSA) levels that are >= 50% above the PSA nadir achieved on androgen deprivation therapy (ADT) and obtained at least 1 week apart\r\n** Computed tomography (CT) or magnetic resonance imaging (MRI) based evidence of disease progression (soft tissue or nodal) according to Prostate Cancer Working Group 2 (PCWG2) criteria or Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, or at least 1 new bone scan lesion as compared to the most immediate prior radiologic studies\r\n* Presence of non-visceral metastases on imaging\r\n* Absence of major symptoms directly attributable to prostate cancer, with the following permissible exceptions:\r\n** Ureteral obstruction secondary to pelvic or retroperitoneal lymphadenopathy\r\n** Bladder outlet obstruction secondary to locally recurrent prostate cancer
Patients who have received systemic chemotherapy for prostate cancer will not be eligible
Any prior treatment for prostate cancer
For participants with metastatic castrate-resistant prostate cancer only:
Patients must have prostate biopsy within 4 months prior to registration showing newly diagnosed prostate cancer, stage T1-3N0M0; in addition, patients must have: Gleason score 6-10
Confirmed diagnosis of prostate cancer
Self-reported prostate cancer diagnosis
Men with a history of prostate cancer
Men with known prostate volume (from prior imaging) of > 60cc
Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate
Prostate size volume ?90 cc
Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR
Concurrent immunotherapy for prostate cancer