MDCalc Guideline Summary: Treatment of Clinically Localized Prostate Cancer

Patients should be counseled about modifiable habits and risk factors, such as smoking and obesity, that can affect their care and outcomes.

Choosing a management strategy should be a shared decision between patient and clinician, taking into account the cancer's risk category, the patient's values and preferences, life expectancy, baseline urinary/sexual/bowel function, expected function after treatment, and whether salvage options would remain available if initial treatment doesn't work.

When feasible, patients should be encouraged to meet with more than one type of prostate cancer specialist (for example, both a urologist and a radiation or medical oncologist) so they can make a well-informed decision.

Patients should be told about clinical trials they may be eligible for and encouraged to consider participating.

If a patient has high-risk disease and a strong family history of breast, ovarian, pancreatic, other GI, or lymphoma malignancies, then consider referral for genetic counseling.

If the patient has very low- or low-risk disease and is asymptomatic, then do not perform abdominopelvic CT or routine bone scan for staging.

Active surveillance is the best available option for very low-risk disease, and the preferred option for most patients with low-risk disease.

Select low-risk patients at high probability of progressing on active surveillance may instead be offered definitive treatment (radical prostatectomy or radiotherapy).

Adding androgen-deprivation therapy to radiotherapy is not recommended for low-risk disease, except to shrink the prostate before brachytherapy.

If the patient is considering whole-gland cryosurgery, clinicians should inform them that side effects are considerable and a survival benefit over active surveillance has not been shown.

Patients considering focal therapy or high-intensity focused ultrasound (HIFU) should be informed that comparative outcome data are lacking and that these are not considered standard care options.

For men with a life expectancy of five years or less, observation or watchful waiting should be recommended.

Genomic biomarker testing does not currently have a clearly defined role in selecting candidates for active surveillance.

Cross-sectional imaging (CT or MRI) and a bone scan should be considered for staging unfavorable intermediate-risk disease. Radical prostatectomy, or radiotherapy combined with androgen-deprivation therapy, are the standard treatment options.

Patients with favorable intermediate-risk disease can be treated with radiation alone, though the supporting evidence is less robust than for radiation combined with androgen-deprivation therapy. Active surveillance may be offered to select patients with favorable intermediate-risk disease, with counseling that this carries a higher risk of eventual metastasis than definitive treatment.

For men with a life expectancy of five years or less, observation or watchful waiting should be recommended. Focal therapy or HIFU should not be presented as standard options, since comparative outcome evidence is lacking.

Staging should include cross-sectional imaging (CT or MRI) and a bone scan.

Radical prostatectomy, or radiotherapy combined with androgen-deprivation therapy, are the standard treatment options.

Active surveillance should not be recommended; watchful waiting is reserved for asymptomatic men with a life expectancy of five years or less.

Cryosurgery, focal therapy, and HIFU should not be offered outside of a clinical trial.

Primary androgen-deprivation therapy alone should not be recommended unless the patient has both a limited life expectancy and local symptoms.

Younger or healthier patients (for example, under 65, or with more than a 10-year life expectancy) are more likely to see a cancer-control benefit from prostatectomy than older patients.

Open and robot-assisted approaches offer similar cancer control, continence recovery, and sexual recovery; robotic, laparoscopic, or perineal techniques are associated with less blood loss than a retropubic approach. Nerve-sparing technique is associated with better recovery of erectile function than non-nerve-sparing technique.

Neoadjuvant androgen-deprivation therapy or other systemic therapy should not be given before prostatectomy outside of a clinical trial.

Patients should be counseled that older age is associated with higher rates of permanent erectile dysfunction and urinary incontinence after surgery.

Pelvic lymphadenectomy can be considered for any patient undergoing prostatectomy and is recommended for those with unfavorable intermediate- or high-risk disease; patients should be counseled about possible complications, including lymphocele.

Patients found to have locally extensive disease at prostatectomy should be counseled about the risks and benefits of adjuvant radiotherapy.

Whole-gland cryosurgery may be considered for low- or intermediate-risk patients who aren't candidates for prostatectomy or radiotherapy because of comorbidities, but who still have a life expectancy of more than 10 years. 

If a patient has a prior TURP, then this is a relative contraindication to whole-gland cryosurgery due to increased urethral sloughing risk; when performed, a third-generation or newer argon-based system should be used.

Patients should be told that erectile dysfunction is an expected outcome of whole-gland cryosurgery, and be counseled about the risks of urinary incontinence and irritative or obstructive urinary symptoms.

It is not established whether concurrent androgen-deprivation therapy improves cancer control with cryosurgery, though it can help reduce prostate size for the procedure.

Focal therapy and HIFU should be presented as lacking robust efficacy evidence; patients should understand that HIFU is FDA-approved for prostate tissue destruction but not specifically for prostate cancer treatment, and that tumor location may affect outcomes when apical treatment is limited to reduce side effects.

Because prostate cancer is often multifocal, patients considering focal therapy should understand it may not be curative and further treatment could be necessary.

Single-modality external beam radiotherapy or brachytherapy may be offered for low-risk disease, alone or combined for favorable intermediate-risk disease.

Patients electing radiotherapy for high-risk disease should be offered 24-36 months of androgen-deprivation therapy alongside external beam radiotherapy, with or without brachytherapy.

Adding androgen-deprivation therapy to radiation increases the likelihood and severity of treatment-related sexual side effects and can cause other systemic effects.

Moderate hypofractionation should be considered when external beam radiotherapy to the prostate alone (without nodal treatment) is planned.

For patients with obstructive urinary symptoms unrelated to cancer, a surgical approach may be preferable; low-dose-rate brachytherapy should be discouraged in these patients or in those with a prior significant transurethral prostate resection.

Patients considering proton beam therapy should be told it offers no demonstrated clinical advantage over other definitive treatments.

Patients considering brachytherapy should be told it has effects similar to external beam radiotherapy for erectile dysfunction and proctitis, but can also worsen urinary obstructive symptoms.

Erectile dysfunction occurs in many patients after prostatectomy or radiation.

Long-term obstructive or irritative urinary symptoms occur in a subset of patients after observation, active surveillance, or radiation, while prostatectomy can actually relieve pre-existing urinary obstruction.

Whole-gland cryosurgery is associated with worse sexual side effects than radiotherapy, with similar urinary and bowel/rectal side effects.

Temporary urinary incontinence occurs in most patients after prostatectomy and persists long-term in a smaller but significant subset, more often than with observation, active surveillance, or radiation.

When counseling on radiotherapy, note that temporary proctitis persists long-term in a small but significant subset, and is rare after observation, active surveillance, or prostatectomy.

Patients should be monitored post-treatment with PSA testing, with the understanding that not all PSA recurrences indicate metastatic disease or will lead to prostate-cancer-specific death.

Patients should be given individualized, risk-based estimates of their likelihood of post-treatment recurrence. 

Clinicians should support patients with survivorship or outcome concerns by helping manage symptoms and connecting them with professional or community-based resources.

Patients electing active surveillance should undergo accurate staging, including a systematic biopsy with ultrasound- or MRI-guided imaging.

Routine surveillance with PSA testing and digital rectal exams should be performed.

A confirmatory biopsy is encouraged within the first two years, with surveillance biopsies continuing thereafter.

Multiparametric MRI may be considered as part of surveillance, though genomic biomarkers have not shown a clear role and are not necessary for follow-up.

If a patient's disease reclassifies to a higher risk category, definitive treatment should be offered.