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.
Evidence of prostate cancer progression by any of the following criteria: radiographic or PSA criteria, or symptomatic progression related to prostate cancer
Solid tumors measurable according to RECIST . or solid tumors not measurable according to RECIST ., but which express tumor markers (e.g., prostate cancer with prostate specific antigen (PSA) expression or ovarian cancer with cancer antigen- (CA-) expression) are eligible.
Prior use of ketoconazole for the purposes of prostate cancer therapy
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
Low-grade prostate cancer
Decision to manage prostate cancer with active surveillance
For brachytherapy, prostate volume must be less than cc prior to AS.
Prostate cancer\r\n* Patients with localized prostate cancer (Tb-Tb) in whom brachytherapy will be integrated as a boost to external beam radiation or used as monotherapy for definitive management
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
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)
Histologic diagnosis of prostate cancer identifying Gleason score of + on one half of the prostate gland in no more than sextants of the prostate gland and not present in more than % of any one core taken systematically. The involvement criterion does not apply to cores taken from MRI suspicious volumes.
Prostate cancer stage up to cTa - N/Nx - M/Mx.
Prostate volume ? mL and ? mL.
Subjects receiving any treatment other than AS for prostate cancer.
Patients with known metastatic prostate cancer.
Patients with a current diagnosis of prostate cancer will be excluded
Ongoing hormonal therapy administered for control of cancer (e.g., breast cancer, prostate cancer), which may be continued throughout the study
Previous systemic cytotoxic treatment for prostate cancer (eg: taxane-based regimen);
Prior local non-surgical therapy to treat prostate cancer (e.g. radiation therapy, brachytherapy)
Prostate cancer proven by histopathology
Asymptomatic or mildly symptomatic from prostate cancer
Patients who are not appropriate candidates for prostate SBRT
Prostatic intraepithelial neoplasia without evidence of prostate cancer.
Metastatic prostate cancer
localized prostate cancer undergoing surveillance or surgery;
Very low risk and low risk groups will be confirmed by Oncotype DX prostate cancer test and provided a genomic prostate score (GPS)
Prostate volume greater than cc on transrectal ultrasound
Prior cabazitaxel or radium for prostate cancer
Previously treated with ketoconazole for prostate cancer for greater than days
Use of -alpha reductase inhibitors (finasteride, dutasteride) specifically prescribed for the treatment of 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
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 months prior to trial)
Prostate cancer
If present, primary disease in the prostate must be stable for > months (defined as no growth > mm)
Prostate cysts or prostate calcifications > cm on ultrasound
Prior radiation therapy to prostate or prostate bed is allowed provided it occurred > months before enrollment to the study
Known active invasive malignancy (except for non-melanomatous skin cancer or anaplastic thyroid cancer; the presence of prostate cancer confined to the prostate with a prostate-specific antigen [PSA] =< ng/mL for more than months also is allowed)
For Cohort C: Has a history of prostate cancer progression on ketoconazole
Previous chemotherapy unless intervention was greater than 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):
Asymptomatic prostate cancer;
Prostatic intraepithelial neoplasia without evidence of prostate cancer
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.
Previous surgery for prostate cancer
Ultrasound or CT estimate of prostate volume > grams
Have an active malignancy other than prostate cancer that requires therapy
Prostate gland volume should be no greater than 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 > cc or pubic arch interference study demonstrating unacceptable prostate access by the transperineal approach
Prior salvage treatment to the primary prostate cancer or pelvis is allowed
Received prior therapeutic intervention for metastatic prostate cancer
Additionally, patients will be required to meet the following criteria \r\n* Karnofsky performance status (KPS) >= \r\n* Prostate volume =< cc (cytoreductive androgen deprivation therapy prior to brachytherapy of =< months duration will be allowed to achieve this goal); for patients with a prostate volume between - ccs, hormone therapy will be at the discretion of the physician\r\n* International Prostate Symptom Score =<
Previously treated with ketoconazole for prostate cancer for greater than 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 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 (PCWG) criteria or radiological progression according to Response Evaluation Criteria in Solid Tumors (RECIST), version ..
Asymptomatic or mildly symptomatic prostate cancer.
Stage T prostate cancer by clinical examination or radiologic evaluation
Previous use of immunotherapy or radium- for the treatment of metastatic prostate cancer
Asymptomatic or mildly symptomatic from prostate cancer
Previous treatment with ketoconazole for prostate cancer for greater than days
Previously treated with ketoconazole for prostate cancer for greater than 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
Participants must have radiographic evidence of metastatic prostate cancer
Asymptomatic or mildly symptomatic from prostate cancer; no use of regularly scheduled opiate analgesics for prostate cancer-related pain
Clinical evidence of metastatic prostate cancer
History of progression of prostate cancer while receiving ketoconazole
Small cell prostate cancer
Asymptomatic or mildly symptomatic from prostate cancer
prostate volume ? 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 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;
Inadequate washout of prohibited hormonally active agents or other prior treatments for prostate cancer (PCa)
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 ? year prior to enrollment, or
If < cores then at least one prostate core must contain >= % prostate cancer
Have a confirmed diagnosis of prostate cancer
localized prostate cancer
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 may not have received any prior pharmacologic therapy or RT for prostate cancer
Prostate cancer with the following pathological characteristics:\r\n* Gleason sum >= AND at least discrete core biopsies containing a minimum of % cancer OR\r\n* Gleason pattern + = AND greater than % of biopsies positive for prostate cancer
Prior ketoconazole for prostate cancer
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)
Biologic therapy for prostate cancer
Hormonal therapy for prostate cancer within three months of procedure,
Radiotherapy for prostate cancer,
Patient has a primary diagnosis of localized prostate cancer (T; T, N= M=; T, N=, M=)
Patient has had previous definitive treatment for localized prostate cancer
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 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 nd course of docetaxel provided that \r\n** The first course resulted in a prostate specific antigen (PSA) response (> % reduction in PSA and/or improvement in radiographic findings or pain) and the last dose was >= 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
Prostate cancer diagnosed at age =< years
Prostate cancer diagnosis and a family history potentially indicating a germline mutation (e.g. breast cancer diagnosed at age =< , 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 >= 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 months
Patients with prostate cancer
Diagnosed with prostate cancer
Not diagnosed with prostate cancer
Diagnosis of prostate cancer
Diagnosis of prostate cancer
Has no other active primary malignancy aside from prostate cancer
Has other active primary malignancy aside from prostate cancer
Previous prostate surgery
PROSTATE CANCER: Histologically confirmed 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 or ) and not interfering with activities of daily living
Have a diagnosis of prostate, breast, lung, lymphoma, or gynecological cancer
Subjects without a diagnosis of prostate cancer.
Receiving hormonal therapy for prostate cancer
urothelial, SCHNN, prostate, soft tissue sarcoma, prostate cancer, TNBC, ccRCC, NSCLC: - prior treatments
Having completed definite treatment of localized prostate cancer (surgery or radiation)
Prostate cancer (PCa) diagnosis
Prior diagnosis of prostate cancer
Known personal history of prostate cancer
Arm patients must have treatment-naive, Gleason >= 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 with a previous diagnosis of prostate cancer
Risk of prostate cancer -% calculated with the on-line PCPT prostate cancer risk calculator; PSA value must be obtained within months prior to study entry
Diagnosed with prostate cancer
Have a prostate cancer diagnosis
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 >mL
History of orchiectomy, PCa-specific chemotherapy, brachytherapy, 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.
Histopathology proven prostate cancer.
Histopathologically proven prostate cancer (PCa)
Current investigational therapy for prostate cancer
Diagnosis of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines (T-T disease)
SUB-STUDY III: Investigational therapy for prostate cancer less than days prior to study PET imaging
With a suspicion (elevated prostate specific antigen [PSA] and/or abnormal digital rectal exam)/diagnosis of prostate cancer
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
Have an active malignancy other than prostate cancer that requires therapy
Subjects must have an International Prostate Symptom Score of =<
Prostate volume - cc
Investigational therapy for prostate cancer
INCLUSION CRITERIA (NEXT 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
Patients with known or suspected prostate disease based on clinical data will be included in the study; patients with intermediate to high grade prostate cancer (Gleasons score >= and prostate-specific antigen [PSA] of > ng/dl) will be referred from the outpatient clinics after evaluation by the treating physicians
Plan to undergo external radiation treatment of prostate cancer
Investigational therapy for prostate cancer
Minimum core prostate biopsy showing histologically-confirmed prostate cancer within 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 > months prior to enrollment
Prior prostate cancer-directed therapy including:\r\n* Androgen deprivation therapy\r\n* Radiation therapy to the prostate (external beam or brachytherapy)\r\n* Cryotherapy\r\n* High-intensity focused ultrasound (HIFU)\r\n* Chemotherapy for prostate cancer
Patient is diagnosed with >= stage breast cancer or >= stage prostate cancer (and/or prostate-specific antigen [PSA] > micrograms/L), including patient with recurrent breast or 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 : treatment naive patients with one of the following risk factors: Cancer of the Prostate Risk Assessment (CAPRA) score >= , PSA >= ng/mL and/or Gleason score >= +\r\n* Population : patients with biochemical recurrence after prostatectomy or radiation therapy with a PSA doubling time less than months\r\n**These patients may have received androgen deprivation therapy prior to imaging\r\n* Population : patients with castrate resistant prostate cancer with progressive disease as defined by Prostate Cancer Working Group (PCWG) criteria \r\n** Patients with castrate resistant prostate cancer can be either on treatment or off treatment
Known diagnosis of prostate cancer
Prostate cancer clinical stage Tc
Minimal tumor burden as defined by at least one of the following criteria: \r\n* One single core with >= % cancer burden and >= mm tumor length\r\n* Two or more cores in the same prostate region, each with >= % 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 or higher cancer burden\r\n* Prostate-specific antigen (PSA) >= ng/mL
Individuals who have previously undergone biopsy of the prostate for diagnosis of prostate cancer
ARM I ONLY: For patients with presumed localized disease (any T, N, M), a multiparametric MRI (standard of care at the National Institutes of Health [NIH] Clinical Center) must be performed within months of the F-DCFBC injection with findings suggestive for prostate cancer and a prostate lesion at least mm or greater; must have histopathologic confirmation of prostate cancer prior to F-DCFBC imaging
Disease status: unfavorable intermediate to high-risk prostate cancer, Cancer of the Prostate Risk Assessment Score (CAPRA -)
Suspected stage ? T on rectal examination (organ-confined prostate cancer) within the previous months
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 weeks of Eovist injection) for OATPB expression
Known diagnosis of prostate cancer
Known prostate cancer
For prostate cancer patients, prostate specific antigen (PSA) >
History of 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 =< ng/dl\r\n** Ongoing LHRH antagonist (e.g. degarelix) and serum testosterone =< ng/dl\r\n* Evidence of prostate cancer resistance to castration, as evidenced by at least one of the following:\r\n** consecutive prostate-specific antigen (PSA) levels that are >= % above the PSA nadir achieved on androgen deprivation therapy (ADT) and obtained at least 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 (PCWG) criteria or Response Evaluation Criteria In Solid Tumors (RECIST) . criteria, or at least 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
Confirmed diagnosis of advanced, refractory breast or prostate cancer that is evaluable by radiologic testing. Participants must have experienced tumor progression on or treatment intolerance to at least one prior therapy.
Confirmed diagnosis of prostate cancer
Men with a history of prostate cancer
Men with known prostate volume (from prior imaging) of > cc
Brachytherapy with EBRT in subjects whose prostate volume is >cc
Hormone sensitive relapsing prostate cancer after definitive local therapy (biochemical relapse) OR