[c09aa8]: / clusters / 9knumclustersv2 / clust_2972.txt

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Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within days of registration at moderate- to high-risk for recurrence as determined by one of the following combinations: \r\n* Gleason score - + Tc-Tb (palpation) + prostate-specific antigen (PSA) < ng/mL (includes intermediate- and high-risk patients)\r\n* Gleason score + Tc-T (palpation) + PSA < ng/mL OR Gleason score + >= % (positive) biopsies + PSA < ng/ml\r\n* Gleason score + Tc-Tb (palpation) + PSA > ng/mL\r\n* Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within days of the repeat biopsy procedure
Clinical stage T- N M, Gleason score =< , PSA - ng/mL, or clinical stage any T N M, Gleason score -, PSA =< ng/mL, or clinical stage T- N M, any Gleason score, PSA =< ng/mL, or clinical stage T- N M, Gleason score + , PSA - ng/mL
Subject has high-risk features (e.g., based on Gleason score, PSA, clinical stage, % positive biopsies), and the treating physician feels the subject should undergo radical prostatectomy sooner than planned within the protocol
Histologically confirmed prostate adenocarcinoma (within days of randomization) at intermediate risk for reoccurrence determined by at least one of the following: Gleason Score , PSA > = and < = , T stage Tb - Tc
Must be considered either low-risk (T-Ta, Gleason =< , prostate specific antigen [PSA] < ng/mL) or favorable intermediate-risk (Gleason + = , percentage of positive biopsy cores < %, no more than one National Comprehensive Cancer Network [NCCN] intermediate risk factor)
A minimum of core biopsies must be obtained at baseline. A prostate biopsy within months from screening is allowed for entry requirements. Patients must meet intermediate risk criteria from Gleason score, T stage, and prostate specific antigen (PSA) value by National Comprehensive Cancer Network (NCCN) criteria: cTb-Tc or Gleason (+ or +) or PSA - ng/mL. In addition, the Gleason + or + must be present
High risk prostate cancer defined as extracapsular extension (cTa) or seminal vesicle involvement (cTb) or invasion of adjacent structures (cT), serum PSA > ng/mL or Gleason score of to and/or regional lymph node or
The following tumor stage and Gleason scores: a) clinical >= stage Tc/T tumor with Gleason score >= b) clinical stage >= Tb tumor with Gleason score >= and PSA > ng/ml.
Histologically proven adenocarcinoma of the prostate and: Gleason > OR prostatic specific antigen (PSA) > and more than positive core
High risk prostate cancer (per National Comprehensive Cancer Network [NCCN] criteria): Gleason score - or Ta or PSA > ng/mL or very-high risk prostate cancer (per NCCN criteria): Tb-T
Poor prognosis disease as defined by any of the following:\r\n* PSA nadir >=., or\r\n* Gleason score -, or\r\n* Time from ADT initiation to CRPC of =< months
Favorable risk prostate cancer as defined by:\r\n* Very low-risk:\r\n** Clinical stage Tc disease\r\n** PSA density (PSAD) < . ng/mL\r\n** Gleason score \r\n** =< core biopsies with =< % involvement of any biopsy core with cancer, or unilateral disease =< core biopsies with any percentage involvement OR\r\n* Low risk:\r\n** Clinical stage =< Ta\r\n** PSA < ng/mL\r\n** Gleason score OR\r\n* Low-intermediate risk:\r\n** Clinical stage Tc\r\n** PSA < ng/ml\r\n** Gleason + present in =< % of one core/site as detected by systematic biopsy or MRI/transrectal ultrasound (TRUS) fusion guided biopsy\r\n** Gleason disease in all other cores (maximum of cores with =< % involvement of any core, or if unilateral disease, any percentage involvement)
Men with a diagnosis of very low risk (< % risk of disease relapse after primary treatment, criteria; cTc, Gleason =< , prostate-specific antigen (PSA) < ng/mL, fewer than positive biopsy cores =< % cancer in any core, PSA density < . ng/mL/g); low risk (% risk of disease relapse after primary treatment, criteria; cT-a, Gleason =< , PSA < ng/mL) prostate cancer
Patients belonging in the National Comprehensive Cancer Network (NCCN) high recurrence risk group:\r\n* High risk:\r\n** Clinical stage Ta, or Gleason score = -, or PSA > ng/mL
Pathological diagnosis of adenocarcinoma of the prostate, judged to be at high risk for recurrence based on any of the following (in accordance with the International Society of Urological Pathology (ISUP) Consensus : Gleason score - OR Gleason score of + AND clinical Tb- AND PSA >ng/mL OR N disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries) defined radiologically as greater than mm on short axis using standard CT or MRI, or biopsy proven
Patients must have at least one of the following criteria:\r\n* The serum PSA should be greater than or equal to ng/ml OR study entry PSA must not be obtained during the following time frames: () -day period following prostate biopsy; () following initiation of antiandrogen therapy (ADT)\r\n* The Gleason score should be greater than or equal to OR\r\n* Eligible patients must have appropriate staging studies identifying them as American Joint Committee on Cancer (AJCC) stage T+ adenocarcinoma of the prostate gland; (MR stage Ta without other high risk factors permitted at investigator discretion)
Risk-group classification into the DAmico or National Comprehensive Cancer Network (NCCN) high-risk group, as defined by the presence of any one of the following high-risk factors:\r\n* Pre-biopsy prostate-specific antigen (PSA) >= \r\n* Biopsy Gleason score -\r\n* Clinical stage T
pT-pTpNxMx patients in whom standard National Comprehensive Cancer Network (NCCN) or American Urology Association (AUA) guidelines would suggest are at low risk for pelvic lymph node or metastatic disease and who would not require confirmatory imaging for metastatic disease; this includes patients with Gleason or (T disease) and prostate-specific antigen (PSA) less than
Patients must be candidates for long-term androgen deprivation in combination with EBRT for the treatment of high-risk or locally-advanced prostate cancer by the following criteria:\r\n* High risk disease: Ta or Gleason - or serum PSA > ng/mL\r\n* Gleason also allowed if > % of cores positive for cancer or PSA velocity > ng/mL/year in preceding months\r\n* Locally advanced (very high risk) disease: Tb-T
Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within days of registration at moderate to high risk for recurrence as determined by one of the following combinations:\r\n* Gleason score - + Tc-Tb (palpation) + prostate specific antigen (PSA) < ng/ml (includes intermediate and high risk patients)\r\n* Gleason score + Tc-T (palpation) or > % (positive) biopsies + PSA < ng/ml\r\n* Gleason score + Tc-Tb (palpation) + PSA > ng/ml
National Comprehensive Cancer Network (NCCN) risk category very low, low, or intermediate risk:\r\n* Combined Gleason score =< \r\n* Prostate specific antigen (PSA) within three months of enrollment < ng/ml\r\n* Clinical stage Ta-cNM or clinical stage TaNM
Prostate cancer categorized (as determined by central pathology review) as low risk is defined as Tc-Ta, PSA<, N, M (or presumed N, M if CT/bone scan not done due to low risk of metastases), GS ? , ECOG status ? and estimated life expectancy > years OR intermediate risk is defined as Tb-Tc, PSA<, N, M (or presumed N, M if CT/bone scan not done), GS ? (+ pattern only), ECOG status ? and estimated life expectancy > years. Prostate cancer categorized (as determined by central pathology review) to the very low risk category (Tc, GS ?, PSA < ng/mL, fewer than prostate biopsy cores positive, ?% cancer in any core, PSA density <. ng/mL/g) is not included.
Intermediate or high risk for recurrence according to the following criteria:\r\n* Two or more of the following intermediate risk features for recurrence\r\n** Gleason score = \r\n** Prostate-specific antigen (PSA) - ng/ml\r\n** Clinical stage Tb-Tc\r\n** Percent positive biopsy cores >= % OR\r\n* One or more of the following high risk features for recurrence\r\n** Gleason score -\r\n** PSA > ng/ml\r\n** Clinical stage Ta-T
Eligible patients will have clinical stage Tc, Ta, or Tb, a pre-biopsy PSA level < ng/mL and a biopsy Gleason score of + (or + if fewer than % of the total number of biopsy cores are involved by grade +)
Patients belonging in one of the following risk groups:\r\n* Low: clinical stage (CS( Tb-Ta and Gleason - and PSA =< , or\r\n* Intermediate: CS Tb and Gleason - and PSA =< , or CS Tb-Tb, and Gleason - and PSA =< ng/dL, or Gleason and PSA =< ng/dL
Inclusion Criteria: All of the following criteria are mandatory for inclusion:\n\n - Histological confirmation of prostate adenocarcinoma with a minimum of biopsy cores\n taken within months of randomisation.\n\n - Gleason score ? +\n\n - Men aged ?\n\n - Clinical and MRI stage Tc -Tc, N-X, M-X (TNM th Edition [], See Appendix )\n\n - PSA ? ng/ml\n\n - Pre-enrollment PSA must be completed within days of randomisation\n\n - Patients belonging in one of the following risk groups according to the National\n Comprehensive Cancer Network (www.nccn.org):\n\n - Low risk: Clinical stage T-Ta and Gleason ? and PSA < ng/ml, or\n\n - Intermediate risk includes any one of the following:\n\n - Clinical stage Tb orTc\n\n - PSA - ng/ml or\n\n - Gleason +\n\n - WHO performance status - \n\n - Prostate volume ? cc measured within months of randomisation (height*width*length\n *?/)\n\n - Ability of the research subject to understand and the willingness to sign a written\n informed consent document\n\n Exclusion criteria: One of the following criteria is sufficient for exclusion:\n\n - Clinical stage T or greater\n\n - Gleason score ? + \n\n - High risk disease defined by National Comprehensive Cancer Network (www.nccn.org)\n\n - Previous malignancy within the last years (except basal cell carcinoma or squamous\n cell carcinoma of the skin), or if previous malignancy is expected to significantly\n compromise year survival\n\n - Prior pelvic radiotherapy\n\n - Prior androgen deprivation therapy (including LHRH agonists and antagonists and\n anti-androgens)\n\n - Any prior active treatment for prostate cancer. Patients previously on active\n surveillance are eligible if they continue to meet all other eligibility criteria.\n\n - Life expectancy < years\n\n - Bilateral hip prostheses or any other implants/hardware that would introduce\n substantial CT artifacts\n\n - Medical conditions likely to make radiotherapy inadvisable eg inflammatory bowel\n disease, significant urinary symptoms\n\n - Anticoagulation with warfarin/ bleeding tendency making fiducial placement or surgery\n unsafe in the opinion of the clinician (see section , Treatment).\n\n - Participation in another concurrent treatment protocol for prostate cancer
Presence of adverse pathologic features at the time of prostatectomy (positive surgical margin, pathologic\r\nT?stage ? disease, pathologic Gleason score ? disease, presence of tertiary Gleason grade disease) OR documentation of rising prostate?specific antigen on at least two consecutive draws, with the magnitude of\r\nprostate?specific antigen exceeding . ng/mL
Have progressive advanced prostate cancer based on at least one of the following criteria:\r\n* Gleason score of ? \r\n* Any PSA\r\n* TNM clinical stage T-T, N
At least one of the following:\r\n* Two or more high risk features OR\r\n** Gleason score -\r\n** PSA >= ng/mL within two months prior to registration\r\n** Clinical stage >= T disease, as determined by standard digital rectal examination (DRE)\r\n** Radiographic stage >= T disease as determined by a >= % probability of extracapsular extension or seminal vesicle invasion per reading radiologist\r\n* Any Gleason or disease OR\r\n* > cores of Gleason disease
Subjects must have one of the following risk factors:\r\n* Prostate-specific antigen (PSA) >= and/or\r\n* Gleason score >= and/or\r\n* Clinical or radiographic stage >= Ta per American Joint Committee on Cancer (AJCC) th Edition Staging Manual and/or\r\n* Radiographic pelvic lymph node positive disease and/or\r\n* At least two out of four of the following: PSA -., Gleason score (GS) = +, clinical stage = Tb/Tc, >= % positive biopsy cores
Intermediate risk or high risk prostate cancer patients who are candidates for radiation therapy:\r\n* Gleason >= or\r\n* Clinical or pathological > Tb disease or\r\n* Prostate-specific antigen (PSA) >= ng/mL
No distant metastases on bone scan (only necessary if prostate specific antigen [PSA] >= ng/ml and/or Gleason score >= )
Patients must have low- or intermediate-risk adenocarcinoma of the prostate as defined by:\r\n* Low-risk disease\r\n** Histopathology score (Gleason sum): =< , and T-stage (per current American Joint Committee on Cancer [AJCC] staging criteria): Tc-Ta, and prostate-specific antigen (PSA) < \r\n* Intermediate-risk disease as either:\r\n** Histopathology score (Gleason sum): =< , T-stage (per current AJCC staging criteria): Tc-Ta, and PSA: > but =< Or\r\n** Histopathology score (Gleason sum): with =< % cores positive, T-stage (per current AJCC staging criteria): Tc-Ta, and PSA <
Status post radical prostatectomy with sampling of the pelvic lymph nodes with histologically confirmed adenocarcinoma of the prostate, with the patients falling into either the adjuvant high risk group or the salvage high risk group as indicated below; in those cases where patients undergo a prostatectomy without any sampling of the pelvic lymph nodes, patients will be also considered eligible if they are found to have a negative pelvic computed tomography (CT) or magnetic resonance imaging (MRI) scan which shows no evidence of lymphatic nodal metastases after the prostatectomy\r\n* Adjuvant High Risk Group (undetectable, persistent or decreasing PSA levels before starting therapy) who have NO evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence) who MUST be able to start RT treatments within months of radical prostatectomy with at least one of the disease features:\r\n** Pathologic TN disease and Gleason score >= , or\r\n** Pathologic TaN disease with extracapsular extension and Gleason score >= , or\r\n** Pathologic TbN disease with any Gleason score\r\n* Salvage High Risk Group are those patients with PSA biochemical failure defined by at least detectable PSA level >= . ng/ml or at least consecutive increases over baseline PSA levels at least one month apart, who have NO other evidence of metastatic disease (i.e. no clinical symptoms or radiologic evidence), and WITH AT LEAST ONE of the high risk disease features as defined below:\r\n** Pathologic TbN disease with any Gleason score, or\r\n** Pathologic T-aN disease with Gleason score >= , or\r\n** Pathologic T-aN disease with PSA doubling time =< months, or\r\n** Pathologic T-aN disease with pre-radiation therapy PSA level >= . ng/ml
Patients with prostate cancer on active surveillance at low risk for progression, defined as Prostate-Specific Antigen (PSA) < ng/dL, Gleason score and clinical stage tumor- (cT) are permitted to be in the study at the discretion of the investigator (see exclusion criterion ).
A history of prostate cancer that was identified incidentally following cystoprostatectomy for bladder cancer is acceptable, provided that the following criteria are met: Stage TNM or lower; Gleason score ?; Prostate-specific Antigen (PSA) level undetectable.
Patient must fit DAmico intermediate-risk criteria by clinical stage (Tb-Tc), prostate-specific antigen (PSA) (- ng/mL), and/or Gleason score (Gleason )
Adenocarcinoma of the prostate proven by biopsy within days of study registration with one of the following high risk criteria:\r\n* Gleason score with PSA =< ng/ml and clinical T-, or\r\n* Gleason score -, PSA =< ng/ml and clinical T-, or\r\n* PSA .- ng/ml with Gleason score (GS) < and clinical T-, or\r\n* Clinical T with Gleason score < and PSA =< ng/ml
Prostate adenocarcinoma without distant metastatic disease with either Gleason score >= , PSA >= ng/ml, or Tb or greater disease
Adenocarcinoma of the prostate with intermediate risk disease Tb-Tc or Gleason score or prostate specific antigen (PSA) - ng/ml, without metastatic disease
Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within days prior to registration as determined by having one or more of the following intermediate-risk features: \r\n* Gleason score \r\n* Prostate specific antigen (PSA) > but =< \r\n* Clinical stage Tb-Tc\r\n* Patients previously diagnosed with low risk (Gleason score =< , clinical stage < Ta, and PSA < ) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease according to the protocol criteria are eligible for enrollment within days of the repeat biopsy procedure
Prostate cancer < Gleason score with stable prostate-specific antigen (PSA) over months
Intermediate risk prostate cancer patients will be eligible for this study; intermediate risk grouping will be assessed per National Comprehensive Cancer Network (NCCN) guidelines as: \r\n* Pathologically-proven diagnosis of prostate adenocarcinoma\r\n* PSA - ng/mL or\r\n* Gleason = or\r\n* Clinical stage Tb/c
Participants must have the following features:\r\n* Intermediate-risk disease defined as Gleason + = disease OR\r\n* High-risk disease defined as Gleason - OR PSA > ng/mL OR T disease (by prostate MRI)
Participants must have histologically confirmed malignancy and are candidates for external beam radiation therapy; patients eligible for this study must have intermediate risk disease defined as PSA values between - ng/ml and/or Tb-c and/or Gleason grade ; if all three are present, less than % of the core biopsies can be positive
Patients previously diagnosed with low risk (Gleason score < , clinical stage < Ta, and PSA < ) prostate cancer undergoing active surveillance who are re-biopsied and found to have intermediate risk disease according to the protocol criteria are eligible for enrollment within days of the repeat biopsy procedure
Diagnosed with prostate cancer, T-TbNM Gleason score (GS) -; prostate specific antigen (PSA) <
Patients must have undergone a radical prostatectomy (any surgical technique is permitted) within months from study entry and have high-risk disease define by any of the following:\r\n* Pathological stage Ta, Tb, T (any grade or initial prostate-specific antigen [iPSA])\r\n* Gleason sum >= (any stage or iPSA)\r\n* Initial pre-operative PSA >= ng/mL (any Gleason score [GS] or pT stage)\r\n* Any stage/PSA/Gleason patients with a % or greater chance of biochemical failure at years based on Kattan's nomogram\r\n* Patients with lymph node (LN) positive disease, regardless of iPSA, pT stage or GS provided their post-operative PSA - weeks after surgery is =< . ng/mL (lymph node dissection is desired but not mandated)
All patients must meet one or more of the following disease features: clinical stage >= T; primary Gleason score of OR Gleason score of , or ; serum PSA >= ng/mL; prostate magnetic resonance imaging (MRI) findings consistent with T disease; any clinical stage and PSA > and Gleason score ; a Kattan nomogram predicted probability of being free from biochemical progression at years after surgery of < %
Adenocarcinoma of the prostate with locally advanced prostate cancer without distant metastatic with unfavorable risk features that are defined below: \r\n* Gleason Score >= ; prostate-specific antigen (PSA) any; T-Stage any\r\n* Gleason Score ; PSA >= ; T-Stage any\r\n* Gleason Score ; PSA any; T-Stage T/T
Biopsy proven intermediate risk prostate cancer, which includes patients with any one of the following variables:\r\n* Gleason disease\r\n* Prostate-specific antigen (PSA) - ng/ml\r\n* Clinical Tb-Tc disease\r\n* Note: Patients who only have radiographic evidence of T disease (i.e. extracapsular extension, or seminal vesical invasion radiographically) will not be excluded
Low-risk prostate cancer with Gleason score < and prostate-specific antigen < mg/mL
Histologically confirmed intermediate- to high-risk prostate adenocarcinoma (Tc-Tb, PSA > , and/or Gleason score >= ) who have a greater than % risk of lymph node involvement as determined by the Roach equation
Prostate biopsy must be positive for cancer: clinically localized Tc or Ta, PSA =< , Gleason =< at the time of initial diagnosis; as the intent of serial biopsy is to ensure that the disease has not progressed to the stage or grade of requiring treatment, the presence of a negative biopsy following an initial positive biopsy (coupled with clinically localized Tc or Ta PSA =< and Gleason =< for a patient who has had no treatment) will not render the patient ineligible; if the consecutive biopsy is either negative, or if positive and remains clinically localized Tc or Ta, PSA =< and Gleason =< , the patient is eligible
Localized prostate cancer with at least one of the following National Comprehensive Cancer Network (NCCN) high-risk features:\r\n* Gleason sum >= \r\n* PSA > ng/mL\r\n* Clinical stage >= T
Patients must be candidates for short or long term androgen deprivation in combination with external beam radiation therapy (RT) based on the following criteria:\r\n* Intermediate risk disease: Tb/c, or Gleason , or prostate-specific antigen (PSA) -\r\n* High risk disease: Gleason -, or PSA > , or T/
Intermediate risk prostate cancer patients will be eligible for this study; risk groups will be assigned as per National Comprehensive Cancer Network (NCCN) guidelines; intermediate risk patients will be defined as:\r\n* PSA - ng/ml or\r\n* Gleason score = or\r\n* Clinical stage Tb/Tc
prostate cancer < Gleason score with stable prostate-specific antigen (PSA) over months
Patients must have the following features:\r\n* Gleason >= + = OR\r\n* Gleason + = AND at least one of the following: PSA > ng/mL, or T disease (as determined by MRI)
Histologically confirmed adenocarcinoma of the prostate, clinically localized, low or low-intermediate risk disease (TC/Ta, Gleason =< [+], prostate-specific antigen [PSA] < )
A priori, we will allow men with concurrent benign prostatic hyperplasia (prostate volume > g) to have a PSA between - ng/ml; and include men with low volume Gleason + disease, because such men have similar outcomes on active surveillance to those with Gleason =< +
No restrictions on stage of cancer, Gleason score, and pre-treatment prostate-specific antigen (PSA) level
Must have one or more of the following:\r\n* pTb or pT primary tumor\r\n* Gleason score -\r\n* pN lymph node disease\r\n* Positive surgical margins\r\n* Pre-operative PSA of >= ng/mL
Participants must have had a standard-of-care biopsy within months of the baseline study visit and must have been diagnosed with low-grade, clinically localized prostate cancer (Gleason score =< + with a PSA at baseline < ng/ml in participants < years of age, OR Gleason score =< + with a PSA at baseline =< ng/ml in participants >= years of age); eligible participants will be those men who are able and willing to undergo AS with PSA monitoring and a scheduled biopsy performed at the end of the study
At least high risk prostate cancer defined by NCCN Guidelines Version . (clinical stage ?Ta or PSA > ng/mL or Gleason score ?).
Intermediate to high-risk disease, defined as one of the following factors: PSA > , Tb or greater, or a Gleason score of or greater
Intermediate to high-risk disease (as determined by elevated prostate specific antigen [PSA] [PSA > ], tumor [T]-stage [Tb or greater], Gleason score [Gleason score > ] or other risk factors)
Patients fit criteria for one of the following categories:\r\n* COHORT \r\n** Known localized high risk prostate cancer (PSA > , Gleason - or clinical stage > Tc) with evidence of disease on standard imaging or\r\n* COHORT \r\n** Nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA >= . ng/mL
Intermediate to high-risk disease (as determined by elevated PSA [PSA > ], T-stage [Tb or greater], Gleason score [Gleason score > ] or other risk factors)
Prostate carcinoma patients at high risk for metastasis with prostatespecific antigen (PSA) more than ng/ml and/or Gleason score = / > .
High-risk or very-high risk prostate cancer eligible for standard of care surgery\r\n* At least clinical Ta disease, and/or Gleason >= , and/or PSA > , as per clinical assessment and routine guidelines
Unfavorable risk intermediate prostate cancer eligible for standard of care surgery\r\n* Grade group (Gleason score +) with either PSA - < or clinical stage Tb-c, OR grade group (Gleason +) with PSA <
Intermediate to high-risk disease (as determined by elevated PSA [PSA > ], T-stage [Tb or greater], Gleason score [Gleason score > ] or other risk factors)
Patients must have histopathology confirmed prostate cancer that is Gleason score =< (+) clinical stage =< TaNM with a PSA below ng/mL
Intermediate to high-risk disease (as determined by elevated prostate-specific antigen [PSA] [PSA > ], T-stage [Tb or greater], Gleason score [Gleason score > ] or other risk factors)
Must have previously untreated (with definitive therapy) prostate cancer with intermediate or high risk features defined as:\r\n* Intermediate risk:\r\n** Prostate specific antigen (PSA) level is between and ng/ml or\r\n** Gleason score is or\r\n** Stage Tb or Tc\r\n* High risk:\r\n** Gleason and higher OR\r\n** PSA > at the time of diagnosis OR\r\n** Seminal vesicle involvement OR\r\n** Possible (on magnetic resonance [MRI]) extra-capsular extension (T disease)
INCLUSION CRITERIA (NEXT PATIENTS WITH LOCALLY ADVANCED PROSTATE CANCER): Pathologically confirmed clinically localized intermediate risk or higher prostate cancer (clinical stage >= Tb or Gleason sum >= or PSA >= ng/mL)
Patients with moderate to high-risk disease as defined by D' Amico risk stratification and having at least one of the following:\r\n* Prostate-specific antigen (PSA) level > ng/ml\r\n* Gleason score >= \r\n* Clinical stage >= Tc
Intermediate or high risk prostate cancer (clinical tumor stage Tb or higher, Gleason or higher, or PSA greater than ); previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion)
National Comprehensive Cancer Network (NCCN) high risk disease (cT or Gleason score - or prostate specific antigen [PSA] > )
Candidates with prostate specific antigen (PSA) greater than , digital rectal exam consistent with disease outside the prostate (clinical T/T disease), or Gleason score or greater, should have a bone scan and diagnostic pelvic CT or MRI to exclude metastatic disease; these must be performed within days of registration
Clinical criteria required to be eligible: \r\n* One of the following: \r\n** Pre-treatment prostate specific-antigen (PSA) >= ng/dL, OR \r\n** Clinical T-stage assessed by digital rectal exam of >= Ta, OR\r\n** Radiographic >= Ta on MRI, OR \r\n** Gleason score of >= += \r\n* Visible intraprostatic tumor foci >= cm in largest dimension on T-weighted images based on initial pre-treatment MRI
Adult males with unfavorable intermediate- to high-risk localized disease identified as one of the following three categories for unfavorable intermediate-high risk factors, but must have visible disease on baseline MRI of the following:\r\n* Clinical or radiographic Tb-T primary tumor\r\n* Gleason score - in any core\r\n* PSA >= prior to initiation of therapy
Patients with clinically localized adenocarcinoma of the prostate who are scheduled to undergo radical prostatectomy (RP) with curative intent and have any the following clinico-pathologic features: () Gleason score sum >= + or any Gleason , () PSA > , and/or () clinical stage >= Ta (staging by magnetic resonance imaging [MRI] is allowed)
At least of the following factors: Gleason score(GS) += and/or PSA - and/or Tb/c
Greater than % of biopsy cores positive and at least one other risk factor: Gleason score (GS) and/or PSA - and/or Tb/c