Prostate Cancer Guidelines 

Prostate Cancer Guidelines 

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Guidelines on prostate cancer screening have been issued by the following organizations:

American Cancer Society (ACS)

National Comprehensive Cancer Network (NCCN)

American Urological Association (AUA)

U.S. Preventive Services Task Force (USPSTF)

European Society for Medical Oncology (ESMO)

European Association of Urology/European Society for Radiotherapy and Oncology/International Society of Geriatric Oncology (EAU/ESTRO/SIOG)

The guidelines differ in their recommendations regarding whether or not to provide routine prostate-specific antigen (PSA)–based prostate cancer screening, in what age groups and life expectancies, and at what intervals. The guidelines agree that PSA-based prostate cancer screening requires an informed, shared decision-making process, and that the decision should reflect the patient’s understanding of the possible benefits and risks and should respect the patient’s preferences and values.

The ACS guidelines for early detection of prostate cancer were last updated in 2010. [1] The ACS does not recommend routine screening in any age group. Instead, asymptomatic men with at least a 10-year life expectancy should be given an opportunity to make an informed decision with their health care provider after receiving information on the uncertainties, risks and benefits of screening

Men should receive the information starting at the following ages:

Age 50 for those at average risk of developing prostate cancer

Age 45 for those at high risk, including African Americans and men with a first-degree relative (father, brother, son) diagnosed with prostate cancer before age 65

Age 40 for those at higher risk (more than one first-degree relative diagnosed with prostate cancer at an early age)

For men who are unable to decide whether they wish to be screened, the ACS advises that the patient’s health care provider can make the screening decision, taking into account the patient’s general health preferences and values.

Men who decide to be screened should be tested with a PSA test. A digital rectal exam (DRE) may also be done as a part of screening.

If screening does not detect cancer, the time between subsequent screenings depends on the results of the blood test, as follows:

PSA < 2.5 ng/ml – Retesting may be done every 2 years

PSA ≥ 2.5 ng/ml – Retesting should be done annually

Even after the decision to screen has been made, the discussion about the risks and benefits of testing should be repeated as new information becomes available.

The NCCN recommends performing a baseline evaluation, with a history and physical examination that includes the following:

The clinician should then discuss of the risks and benefits of a baseline PSA test with the patient, and consider a baseline DRE to identify high-risk cancers associated with a seemingly normal PSA. In patients 45-75 years of age, subsequent evaluation is based on the results of those tests, as follows [10] .

For men above the age of 75, screening may be cautiously considered in selected cases of very healthy men with little or no comorbidity. If PSA is measured and is 4 ng/mL or DRE results are very suspicious, the patient should be evaluated for biopsy.

The NCCN notes that men ≥60 years of age with serum PSA <1.0 ng/mL have a very low risk of metastasis or death from prostate cancer and may not benefit from further testing. The same is true of men age 75 years with a PSA of <3.0 ng/mL.

Evaluation for biopsy includes the following:

The current recommendations of the AUA date from 2013 and update the Association’s 2009 Best Practice Statement on Prostate-Specific Antigen (PSA). [2] The guidelines do not recommend routine screening for the following groups:

Any man with a life expectancy less than 10-15 years

Men under 40 years

Men between ages 40 to 54 years at average risk

Men over age 70

For men 55 to 69 years of age, the decision to undergo PSA screening involves weighing the benefits and risks. The guidelines strongly recommend:

Shared decision-making for men age 55-69 years who are considering PSA screening, and proceeding based on patients’ values and preferences

A routine screening interval of two years or more in those men who have participated in shared decision-making and decided on screening.

The USPSTF guidelines, which were updated in 2012, recommend against PSA-based screening for prostate cancer, while recognizing that some men will continue to request screening. [3] In such cases, screening should not be ordered prior to shared decision making that weighs the benefits and risks and takes into account the patient’s preferences and values.

Likie USPSTF, ESMO guidelines recommend against population-based PSA screening for prostate cancer, as well as screening of asymptomatic men over 70 years old. [4]

In 2016, revised joint guidelines were issued by EAU/ESTRO/SIOG with the recommendation that men who are informed and request an early diagnosis should be given a PSA test and undergo a digital rectal examination (DRE). PSA testing should be offered to the following groups at elevated risk for developing prostate cancer [5] :

Follow-up testing at intervals of 2 years for the following at risk groups:

Postpone follow-up to 8 years in those not at risk.

Discontinue testing based on life expectancy and performance status; men who have a life expectancy of < 15-years are unlikely to benefit.

The National Comprehensive Cancer Network (NCCN) advises that although standard MRI techniques can be considered for initial evaluation of high-risk patients, multiparametric magnetic resonance imaging (mpMRI) can be used in the staging and characterization of prostate cancer. mpMRI images are defined as those acquired with at least one more sequence in addition to the anatomic T2-weighted images, such as diffusion-weighted imaging and dynamic contrast images. In addition, the NCCN guidelines recommend considering mpMRI in patients undergoing active surveillance if anterior and/or aggressive cancer is suspected when PSA increases and systematic prostate biopsies are negative. [6]

The 2016 EAU/ESTR/SIOG guidelines recommend mpMRI prior to performing a repeat biopsy when clinical suspicion of prostate cancer persists in spite of negative biopsies. During repeat biopsy, target any mpMRI lesions seen. Additionally, the guidelines recommend performing mpMRI for local staging and metastatic screening in predominantly Gleason pattern 4 intermediate risk patients and for local staging in high-risk localised prostate cancer. [5]

 

Guidelines from the American Urological Association, the American Society for Radiation Oncology (ASTRO) and the Society of Urologic Oncology (SUO) for management of clinically localized prostate cancer include the following recommendations for very-low-risk and low-risk disease [7] :

For patients with intermediate-risk disease, care recommendations are as follows:

For high-risk patients the guideline recommendations include the following:

The 2015 ESMO guidelines recommend watchful waiting with delayed hormone therapy as an option for localized disease or as an alternative for men with localized or locally advanced disease who are unwilling or unsuited for radical therapy. [4]

Other recommended treatment options include [4] :

Active surveillance for men with low-risk disease 

Radical prostatectomy (RP) or radiotherapy (external beam or brachytherapy) for men with low- or intermediate-risk disease 

Primary androgen deprivation therapy (ADT)  alone is not recommended for treatment of non-metastatic disease 

For patients with high-risk or locally advanced prostate cancer, external beam RT plus hormone treatment or RP plus pelvic lymphadenectomy 

The NCCN guidelines include scanning technology utilizing fluorine-18 sodium fluoride (18 F-NaF) as the tracer for the subsequent positron-emission tomography (PET) scan as an option for men with prostate cancer who undergo a bone scan to search for metastatic disease. PET and hybrid imaging bone scans appear more sensitive than conventional 99-technetium bone scans. [6]

The following organizations have published guidelines for the treatment of castration-resistant prostate cancer (CRPC):

ASCO and CCO released a joint clinical practice guideline for treatment of men with mCRPC in 2014. [8] The guideline recommendations include the following:

Pharmacologic androgen deprivation therapy (ADT) should be continued indefinitely

Offer patients one of three treatment options—abiraterone/prednisone, enzalutamide, or radium-223 (if cancer has spread to bone)—in addition to hormone deprivation

When considering chemotherapy, docetaxel/prednisone should be an option but side effects must be discussed

Offer cabazitaxel to men whose disease worsens even if docetaxel has been tried, but again, discuss side effects

Offer sipuleucel-T to men with no symptoms or minimal symptoms of cancer

Offer mitoxantrone, but include a discussion of the drug’s limited clinical benefit and side effect risk

Offer ketoconazole or the anti-androgen therapies bicalutamide, flutamide or nilutamide but discuss the limited clinical benefit for these three medications

Do not offer the drugs bevacizumab (Avastin), estramustine, or sunitinib

Begin discussion of palliative care early on while discussing treatment options

American Urological Association guidelines for the management of CRPC describe six index-patient scenarios for which recommendations could be formulated. [9]

Index patient no. 1: Asymptomatic non-metastatic CRPC

Recommendations are as follows:

Observation with continued ADT

First-generation antiandrogens (flutamide, bicalutamide, and nilutamide) or first-generation androgen-synthesis inhibitors (ketoconazole plus steroid) to patients unwilling to accept observation.

Systemic chemotherapy or immunotherapy should not be offered to patients with non-metastatic CRPC outside the context of a clinical trial

Index patient no. 2: Asymptomatic or minimally-symptomatic, metastatic CRPC with good performance status and without prior docetaxel chemotherapy

Recommendations are as follows:

Abiraterone plus prednisone, enzalutamide, docetaxel, or sipuleucel-T

First-generation antiandrogen therapy or ketoconazole plus steroid or observation to patients who do not want or cannot have one of the standard therapies

Index patient no. 3: Symptomatic, metastatic CRPC with good performance status and no prior docetaxel chemotherapy

Recommendations are as follows:

Docetaxel

Abiraterone plus prednisone, enzalutamide, or docetaxel

Ketoconazole plus steroid, mitoxantrone, or radionuclide therapy for patients who do not want or cannot have one of the standard therapies

Radium-223 to patients with symptoms from bony metastases and without known visceral disease

Treatment with either estramustine or sipuleucel-T should not be offered

Index patient no. 4: Symptomatic, metastatic CRPC with poor performance status and no prior docetaxel chemotherapy

Recommendations are as follows:

Abiraterone plus prednisone or enzalutamide

Ketoconazole plus steroid or radionuclide therapy to patients who are unable or unwilling to receive abiraterone plus prednisone

Docetaxel or mitoxantrone chemotherapy in select cases, specifically when performance status is directly related to the cancer

Radium-223 to patients with symptoms from bony metastases and without known visceral disease in select cases, specifically when the performance status is directly related to symptoms related to bone metastases.

Treatment with sipuleucel-T should not be offered

Index patient no. 5: Symptomatic, metastatic CRPC with good performance status and prior docetaxel chemotherapy

Recommendations are as follows:

Abiraterone plus prednisone, cabazitaxel, or enzalutamide

If the patient received abiraterone plus prednisone prior to docetaxel chemotherapy, offer cabazitaxel or enzalutamide

Ketoconazole plus steroid if abiraterone plus prednisone, cabazitaxel, or enzalutamide is unavailable

Re-treatment with docetaxel for patients who were benefiting from but discontinued treatment with docetaxel because of reversible adverse effects

Radium-223 to patients with symptoms from bony metastases and without known visceral disease

Index patient no. 6: Symptomatic, metastatic CRPC with poor performance status and prior docetaxel chemotherapy

Recommendations are as follows:

Palliative care

For selected patients, offer treatment with abiraterone plus prednisone, enzalutamide, ketoconazole plus steroid, or radionuclide therapy

Systemic chemotherapy or immunotherapy should not be offered

Bone health recommendations

Because the skeletal system is the most common site for prostate cancer metastasis, the guideline also makes recommendations regarding bone health not specific to any index patient group:

Offer preventive treatment (eg, supplemental calcium, vitamin D) for fractures

Choose either denosumab or zoledronic acid as preventative treatment for skeletal-related events

The NCCN guidelines for prostate cancer offer treatment recommendations for CRPC based on the presence or absence of visceral metastases. For the most part, these recommendations are based on high-level evidence and are supported by uniform NCCN consensus (category 1 recommendations). [6]

CRPC without distant metastasis

Enrollment in clinical trial is preferred

Observation is acceptable

Secondary hormone therapy can be considered for patients with prostate-specific antigen (PSA) doubling < 10 months; anti-androgen therapy is acceptable for patients who previously received medical or surgical castration, ketoconazole, corticosteroids, diethylstilbestrol or other estrogens

CRPC with bone metastases

Measures to promote bone health include the following:

Zoledronic acid or denosumab

Avoidance of invasive dental surgery during treatment

Calcium and vitamin D supplements to prevent hypocalcemia during treatment

Radium-233 can be used to treat symptomatic bone metastases without visceral metastases.

Metastatic CRPC with no visceral metastases

Sipuleucel-T for asymptomatic or minimally symptomatic patients

Abiraterone plus prednisone or enzalutamide for asymptomatic patients

Docetaxel with prednisone for symptomatic patients; may also be considered in a symptomatic patients with signs of rapid progression

Radium-233 for symptomatic patients

Secondary hormone therapy or enrollment in clinical trial may be considered

Second-line treatment for patients with no visceral metastases who experience progression of disease after treatment with enzalutamide or abiraterone is as follows:

Docetaxel with prednisone

Abiraterone, if the patient had previously taken enzalutamide

Enzalutamide, if the patient had previously taken abiraterone

Radium-233 for bone-predominant disease

Sipuleucel-T for asymptomatic or minimally symptomatic patients with no liver metastases, life expectancy > 6 mo, and ECOG performance status 0-1

Clinical trial

Other secondary hormone therapy (eg, antiandrogen, antiandrogen withdrawal, ketoconazole, corticosteroids, diethylstilbestrol or other estrogen)

Best supportive care

Second-line treatment for patients with no visceral metastases who experience progression of disease after treatment with docetaxel is as follows:

Enzalutamide

Abiraterone with prednisone

Radium-233 for bone-predominant disease

Cabazitaxel with prednisone

Sipuleucel-T for asymptomatic or minimally symptomatic patients with no liver metastases, life expectancy > 6 mo, and ECOG performance status 0-1

Clinical trial

Docetaxel rechallenge

Alternative chemotherapy (mitoxantrone)

Other secondary hormone therapy (eg, antiandrogen, antiandrogen withdrawal, ketoconazole, corticosteroids, diethylstilbestrol or other estrogen)

Best supportive care

Metastatic CRPC with visceral metastases

Docetaxel with prednisone (preferred treatment)

Addition of estramustine to docetaxel not recommended

Enzalutamide (category 1)

Abiraterone for men who decline chemotherapy

Second-line treatment for patients with visceral metastases who experience progression of disease after treatment with enzalutamide or abiraterone is as follows:

Docetaxel with prednisone

Clinical trial

Abiraterone, if the patient had previously taken enzalutamide

Enzalutamide, if the patient had previously taken abiraterone

Other secondary hormone therapy (eg, antiandrogen, antiandrogen withdrawal, ketoconazole, corticosteroids, diethylstilbestrol or other estrogen)

Best supportive care

Second-line treatment for patients with visceral metastases who experience progression of disease after treatment with docetaxel is as follows:

Enzalutamide

Abiraterone with prednisone

Cabazitaxel with prednisone

Clinical trial

Docetaxel rechallenge

Alternative chemotherapy (mitoxantrone)

Other secondary hormone therapy (eg, antiandrogen, antiandrogen withdrawal, ketoconazole, corticosteroids, diethylstilbestrol or other estrogen)

Best supportive care

EAU, ESTRO and SIOG released a joint clinical practice guideline for prostate cancer in 2016. The guideline recommendations for patients with mCRPC  include the following [5] :

Treat with life prolonging agents (alphabetical order: abiraterone, docetaxel, enzalutamide, radium-223, sipuleucel-T). Base the choice of first line treatment on the performance status, symptoms, comorbidities and extent of disease.

Candidates for cytotoxic therapy should be offered docetaxel with 75 mg/m2 every 3 weeks.

In patients with progression following docetaxel chemotherapy, offer further life-prolonging treatment options, which include cabazitaxel, abiraterone, enzalutamide and radium-223.

Offer bone protective agents to patients with skeletal metastases to prevent osseous complications. However, the benefits must be balanced against the toxicity of these agents, and jaw necrosis, in particular, must be avoided.

Offer calcium and vitamin D supplementation when prescribing either denosumab or bisphosphonates.

Treat painful bone metastases early on with palliative measures such as EBRT, radionuclides, and adequate use of analgesics.

In patients with spinal cord compression, start immediate high-dose corticosteroids and assess for spinal surgery followed by irradiation. Offer radiation therapy alone if surgery is not appropriate.

 

M0 Castration Naive Diease can be treated with Orchiectomy or LHRH agonist +/- antiandrogen or LHRH antagonist or in selected patients observation

M1 Castration Naive Disease can be treated with ADT similar to M0 disease expect a atleast 7 day pretreatment with antiandrogen is recommended to prevent testosterone flare.  Patietns can be considered for Docetaxel 75 mg/m2 with or without prednisone for 6 cycles in addition to ADT.  Patients with low volume disease ( less than 4 metastatic sites) have less certain benefit from early treatment with docetaxel. 

Patients suspected to small cell should undergo biopsy and if confirmed should be considered for clinical trial or alternatively treated with cisplatin/etoposide or carboplatin/etoposide or docetaxel/carboplatin [6]

 

 

 

Wolf AM, Wender RC, Etzioni RB, Thompson IM, D’Amico AV, Volk RJ, et al. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin. 2010 Mar-Apr. 60(2):70-98. [Medline].

[Guideline] Carter HB, Albertsen PC, Barry MJ, Etzioni R, Freedland SJ, Greene KL, et al. Early detection of prostate cancer: AUA guideline. American Urological Association. Available at https://www.auanet.org/guidelines/early-detection-of-prostate-cancer-(2013-reviewed-and-validity-confirmed-2015). 2015; Accessed: July 22, 2017.

Moyer VA. Screening for prostate cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Jul 17. 157(2):120-34. [Medline].

[Guideline] Parker C, Gillessen S, Heidenreich A, Horwich A, ESMO Guidelines Committee. Cancer of the prostate: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015 Sep. 26 Suppl 5:v69-77. [Medline]. [Full Text].

[Guideline] Mottet N, Bellmunt J, Briers E, et al. EAU-ESTRO-SIOG GUIDELINES ON PROSTATE CANCER. European Association of Urology. Available at http://uroweb.org/wp-content/uploads/EAU-Guidelines-Prostate-Cancer-2016.pdf. March 2016; Accessed: August 28, 2016.

[Guideline] National Comprehensive Cancer Network. Prostate Cancer. National Comprehensive Cancer Network. Available at https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf. Version 2.2017 — feb, 2017; Accessed: July 30 2017.

[Guideline] Prostate Cancer Clinical Guideline Update Panel. Clinically Localized Prostate Cancer: AUA/ASTRO/SUO Guideline. American Urological Association. Available at https://www.auanet.org/guidelines/clinically-localized-prostate-cancer-new-(aua/astro/suo-guideline-2017). 2017; Accessed: July 22, 2017.

Basch E, Loblaw DA, Oliver TK, Carducci M, Chen RC, Frame JN, et al. Systemic therapy in men with metastatic castration-resistant prostate cancer:American Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline. J Clin Oncol. 2014 Oct 20. 32(30):3436-48. [Medline].

[Guideline] Cookson MS, Roth BJ, Dahm P, et al. Castration-Resistant Prostate Cancer: AUA Guideline. American Urological Association. Available at https://www.auanet.org/guidelines/castration-resistant-prostate-cancer-(2013-amended-2015). Published 2013; Amended 2015; Accessed: July 22, 2017.

[Guideline] National Comprehensive Cancer Network. Prostate Cancer Early Detection. National Comprehensive Cancer Network. Available at https://www.nccn.org/professionals/physician_gls/pdf/prostate_detection.pdf. Version 1.2017 — June 5, 2017; Accessed: July 30, 2017.

Skolarus TA, Wolf AM, Erb NL, Brooks DD, Rivers BM, Underwood W 3rd, et al. American Cancer Society prostate cancer survivorship care guidelines. CA Cancer J Clin. 2014 Jul-Aug. 64(4):225-49. [Medline].

Bagi RP Jana, MD Professor of Medicine (Genitourinary Oncology), Division of Hematology and Oncology, University of Texas Medical Branch at Galveston

Bagi RP Jana, MD is a member of the following medical societies: American Cancer Society, American Medical Association, American Society of Clinical Oncology, SWOG

Disclosure: Nothing to disclose.

Mariclaire Cloutier Freelance editor, Medscape Drugs & Diseases

Disclosure: Nothing to disclose.

Prostate Cancer Guidelines 

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