Recommendations

Level Of recommendation

1-Screening for prostate cancer

Early PSA testing (baseline PSA followed by risk-adapted follow-up) can be offered to men >50 years, men >45 years with a positive family history of prostate cancer, and BRCA1/2 carriers >40 years

Conditional

2-Work up for newly diagnosed prostate cancer

History and physical examination

 Personal and family history, Physical examination, DRE , Assessment of ECOG performance status should be done

Strong

Assessment of life expectancy is a very essential tool in the plan of management of prostate cancer , Life expectancy should  be estimated using: The WHO’s Life Tables by country

Strong

Laboratory Studies

Base line tumor marker:  serum PSA (Total, Free )  is the recommended  initial laboratory studies for localized  prostate cancer

Strong

Radiological Studies

TRUS is  the initial imaging studies for diagnosis of  prostate cancer

MRI prostate or mpMRI (if available ) is to be used in the staging and characterization of prostate cancer

Conditional

Radiologists should utilize PI-RADS V 2.1 in the reporting of multi-parametric MRI (mpMRI) imaging

Strong

Standard MRI techniques should be used for examination of the pelvis and/or abdomen for initial evaluation of intermediate and high / very high risk patients and for planning purposes in radiotherapy protocols

Strong

Bone imaging is indicated in the initial evaluation of intermediate and high / very high risk patients to exclude skeletal metastasis

Strong

PSMA-PET if available to be considered as an alternative to standard imaging of bone and soft tissue in high and very high risk patients .

Conditional

Initial Biopsy 

Definitive diagnosis of cancer prostate requires 6- 12 core biopsies of the prostate, using a needle under transrectal / transperineal ultrasound  guidance.

Strong

For biopsy-naïve patients who have a suspicious lesion on MRI, clinicians can perform targeted biopsies of the suspicious lesion either cognitive or software guided 

Conditional

3-Risk stratification and Management of Localized / Locally advanced prostate cancer

Patients with localized prostate cancer should be classified into very low , low , intermediate ( Favourable and unfavourable)  , high and very high risk groups

Strong

Risk stratification of clinically localized prostate cancer facilitate care decisions and guide clinicians in the implementation of selected management options..

Strong

Patients with prostate cancer should be managed through a multidisciplinary team ( Urologist , Medical Oncologist , Radiation oncologist , Radiologist  and Pathologist )

Strong

It is recommended to  use one of the following options in the management of very low/low risk groups (according to MDT decision and patient preference):

If expected patient survival ≥ 10  years,:

Strong

In asymptomatic patients with prostate cancer and < 10 years life expectancy , watchful waiting is recommended

Strong

According to MDT decision and patient preference; It is recommended  to use  one of the following options in the management of favourable intermediate risk groups ( Life expectancy ≥ 10  years):

Strong

It is recommended to use  one of the following options in the management of favourable intermediate risk prostate cancer  (Expected Survival 5-10 Years ):

Strong

Brachytherapy monotherapy  is a recommended  option for patients with very low, low, or favorable intermediate-risk prostate cancer and life expectancy > 10 years  with acceptable 10-year recurrence-free survival rate for LDR/HDR brachytherapy

Strong

RP + PLND  or EBRT + short course ADT ( 6 months ) are the recommended  options for management of unfavourable intermediate risk patients.

Strong

Long term ADT ( 2- 3 years ) combined with EBRT is the recommended  primary treatment for  high risk or very high risk prostate cancer patients  

Strong

RP and PLND is a valid option in very selected cases with high or very high risk prostate cancer based on MDT discussion

Conditional

Locally advanced prostate cancer

Neoadjuvant ADT ( 4-6 months ) followed by ADT + EBRT , then ADT for 2 years  is the recommended treatment option for patients with locally advanced prostate cancer 

Strong

RP and PLND  can be an option in selected cases  of locally advanced prostate cancer according to MDT decision

Conditional

Patients who choose active surveillance program should have regular follow-up with baseline biopsy ,  serum PSA level  , Prostatic MRI  and key principles of active surveillance  include:

 PSA every 3months unless there is an earlier clinical indication

DRE  every 6 months unless there is an earlier clinical indication.

Repeat  radiological examination +/- Prostatic biopsy if there is a clinical indication

Conditional

Watchful waiting  should involve monitoring with a history and physical exam every 12 months (without surveillance biopsies) until symptoms develop.

Strong

Radical prostatectomy

RP +/- PLND is the recommended  therapy for any patient with clinically localized prostate cancer that can be completely excised surgically, Life expectancy of ≥10 years, and  has no serious comorbid conditions that would contraindicate an elective operation

Strong

Extended PLND is recomended when PLND is performed as it provides more complete staging and may cure some patients with microscopic metastases . An extended PLND includes removal of all node-bearing tissue from an area bound by the external iliac vein anteriorly, the pelvic sidewall laterally, the bladder wall medially, the floor of the pelvis posteriorly, Cooper's ligament distally, and the internal iliac artery proximally.

 Strong

Robotic surgery could be done (if available ) in selected university hospitals after gaining sufficient learning curve

Conditional

Radiotherapy

Indications of Post-prostatectomy ART include Adverse pathologic features : Positive margins, Seminal vesicle invasion, Extracapsular extension) or persistent PSA levels (PSA does not fall to undetectable levels).

 Strong

Radiotherapy is one of the recommended modalities of radical therapy for localized prostate cancer patients without severe complications, where the results of definitive radiotherapy are comparable to radical prostatectomy for patients with similar recurrence risk.

Strong

Radiotherapy in prostate cancer is recommended to be in the treatment plan through an expert MDT and should be carried out in a well-equipped centres with trained personnel and adopting advanced EBRT techniques that include:  IMRT, VMAT , image-guided (IGRT) and SBRT facilities.

Good practice statement

Short-term precise hypo-fractionated radiotherapy can be used as it shortens the treatment course significantly while the treatment results are equivalent to those of conventional high-dose radiotherapy.

Conditional

Addition of a focal boost to the intra-prostatic lesion can be used as it improved disease free survival  for patients with localized intermediate- and high-risk prostate cancer without impacting toxicity and quality of life.

Conditional

Prophylactic nodal radiation should be considered in locally advanced prostate cancer and clinically positive nodes , and it should be dose escalated in the presence of positive nodes by imaging procedures.

Strong

Androgen deprivation therapy

ADT includes LHRH agonist as Goserline or leuprolide , first  generation antiandrogen (Bicalutamide) should be given  at least  7 days  before LHRH agonist only to avoid flare up phenomenon .

Strong

We recommend against Combined androgen blockade (medical or surgical castration combined with an antiandrogen) as it provides modest to no benefit over castration alone in patients with prostate cancer

Strong

ADT should not be used as monotherapy in clinically localized prostate cancer unless there is a contraindication to definitive local therapy, such as life expectancy less than 5 years and presence of comorbidities. Under those circumstances, ADT may be an acceptable alternative if the disease is high or very high risk

Conditional

Follow Up

For patients initially treated with definitive therapy with intent to cure, serum PSA levels should be measured every 3 months for the first 2 years then every  6 months till 5 years and then annually.

Strong

4- Management of biochemical recurrence

Laboratory Studies

 Serum PSA (Total, Free ) , PSA doubling time ( PSA DT )   are the recommended laboratory studies  for patients with biochemical recurrence

Strong

Radiological Studies

Standard MRI techniques for examination of the pelvis and/or abdomen  is recommended as part of workup for recurrence or progression

Strong

Bone imaging should be considered for the evaluation of the patient post-prostatectomy when there is failure of PSA to fall to undetectable levels, or when there is undetectable PSA after RP with a subsequent detectable PSA that increases on 2 or more subsequent determinations.

Strong

Bone imaging should be considered for the evaluation of patients with an increasing PSA or positive DRE after RT

Strong

In patients with a BCR after local therapy, prostate-specific membrane antigen (PSMA)-PET ( if available ) to be done in lieu of conventional imaging or after negative conventional imaging for further evaluation of clinical recurrence.

Conditional

Treatment of biochemical recurrence

Salvage RT in addition to Six months ADT ( concurrent / Adjuvant ) is recommended for patients with BCR following RP and with high-risk features :

( Gleason  Grade Group 4 to 5, PSADT ≤ 6months, persistently detectable post-operative PSA, seminal vesicle involvement). 

 Strong

Salvage radiation for a detectable prostate-specific antigen (PSA) after RP is more effective when given at lower levels of PSA.

Strong

Post-prostatectomy SRT is to treat prostate bed ± pelvic LN  , where PSA cut-off value for SRT (range: 0.2–0.5 ng/ml) and 0.2 ng/ml is the preferable value

Conditional

Immediate rather than deferred ADT is recommended in men with biochemical recurrence after Radiotherapy is recommended  if there are high-risk features for early metastases, including a   clinical Gleason score 8 -10, or an interval to biochemical recurrence ≤18 months after definitive radiotherapy

Strong

Salvage RP and PLND can be offered in selected cases with biochemical recurrence after Radiotherapy according to MDT decision

Conditional

5- Management of Metastatic Hormone Sensitive , Non Metastatic Castrate Resistant , Metastatic Castrate Resistant Prostate Cancer

History and physical examination

Including assessment of ECOG Performance status , Presence of peripheral neuropathy , History of seizures or cerebrovascular problems , History of cardiovascular disease and other comorbidities and  Risk of fall & fractures

Good practice statement

Laboratory Studies

 CBC, KFT’s and LFT’s, Serum Testosterone Level , HbA1c,  serum PSA (Total, Free )  , PSA DT , serum cholesterol /LDL & HDL & S triglycerides , thyroid functions   are the recommended work up for advanced prostate cancer

Good Practice statement

Imaging studies

Standard CT techniques should be used for examination of the chest , abdomen and pelvis as an initial  evaluation of advanced  prostate cancer

Strong

Bone imaging should be considered for the evaluation of patients with advanced prostate cancer

Strong

PSMA-PET if available to be considered as an alternative to standard imaging of bone and soft tissue in patients with advanced cancer prostate  .

Conditional

Echocardiogram should be done to assess the cardiac condition as it can guide further management

Strong

Pathological examination  

 Transrectal US Biopsy is recommended in cases with de novo metastatic prostate cancer

Strong

In previously treated PC with previous biopsy , we recommend against  re-biopsy from the prostate in metastatic setting

Good practice statement

Biopsy from accessible metastatic lesions to identify patients with small  cell/neuroendocrine histomorphologic features can be done in patients with metastatic CRPC

Conditional

Metastatic hormone sensitive prostate cancer

Patients with low-volume metastatic HSPC should be considered for ADT and local radiotherapy to the prostate if not previously given

Strong

ADT plus docetaxel is the standard of care in treatment of patients with high-volume metastatic HSPC

Strong

ADT plus Apalutamide  or Enzalutamide is the standard of care in treatment of patients with high-volume metastatic HSPC who are not candidate for docetaxel

Strong

Radiation therapy to the prostate should NOT be performed in men with high-volume metastatic disease outside the context of a clinical trial unless for palliative intent

Strong

Non Metastatic Castrate Resistant Prostate Cancer

Castrate levels of testosterone should be documented in patients with signs of progression, If serum testosterone levels are <50 ng/dL, the patient should undergo disease workup with bone and soft tissue imaging

Strong

Apalutamide or enzalutamide should be considered for men with non metastatic  CRPC

Strong

Metastatic Castrate Resistant Prostate Cancer

Abiraterone acetate plus prednisone + ADT is the standard of care in the management of patients with metastatic CRPC previously treated with Docetaxel

Strong

Enzalutamide +ADT is the standard of care in the management of patients with metastatic CRPC previously treated with docetaxel and not candidate for Abiraterone acetate + prednisone

Strong

Docetaxel + ADT is the standard of care in the management of patients with metastatic CRPC not previously treated with Docetaxel

Strong

Patients being treated for CRPC should  be closely monitored with radiologic imaging (CT, bone imaging), PSA tests, and clinical exams for evidence of progression.

Strong

Urgent MRI of the spine to detect cord compression is very strongly recommended in men with CRPC with vertebral metastases and neurological symptoms

Strong

6-Special  considerations

Docetaxel should be avoided in patients with ECOG PS≥ 2, IHD, presence of comorbidities, grade III/IV peripheral neuropathy , Absolute neutrophil count < 1000/mm3

Strong

Apalutamide should be avoided in patients with recent cardiovascular disease or  hypothyroidism .

Strong

Enzalutamide should be avoided in seizure prone patients or with history of seizures 

Strong

Abiraterone should be avoided in patients with uncontrolled diabetes , hepatic impairment , cardiovascular disease

Strong

Therapy should be continued until clinical progression or intolerable toxicity 

Strong

Palliative RT is recommended  for symptomatic control and prevention of complications from metastatic lesions as bone or brain .

Strong

Bisphosphonate or denosumab is recommended in patients with bone metastases from CRPC at risk for clinically significant skeletal-related events (SREs)

Strong

The use of a second AR inhibitor (abiraterone after enzalutamide  or vice versa) is not recommended

Strong

Germline testing for BRCA2 and genes associated with cancer predisposition syndromes can be done in patients with positive family history of cancer .

Conditional

Tumor testing for homologous recombination genes and mismatch repair defects (or microsatellite instability) can be considered in patients with mCRPC

Conditional

Small cell/neuroendocrine carcinoma of the prostate should be considered in patients with disease that no longer responds to ADT and are positive for metastases. These relatively rare tumors are associated with low PSA levels despite large metastatic burden and visceral disease.

Strong

Etoposite / platinum is the standard of care in the management of small cell neuroendocrine tumors of the prostate

Strong

Life style measures is recommended  to maintain bone health are recommended for men on ADT: weight-bearing exercise, stop smoking , adequate calcium intake and vitamin D status

Strong