Favorable Intermediate Risk Prostate Cancer

Gene And Protein Tests For Prostate Cancer

Active Surveillance in Favorable Intermediate-Risk Prostate Cancer

For men with prostate cancer that is localized , a major issue is that its often hard to tell how quickly the cancer is likely to grow and spread. This can make it hard to decide if the cancer needs to be treated right away, as well as which types of treatment might be good options.

Some types of lab tests, known as genomic, molecular, or proteomic tests, can be used along with other information to help better predict how quickly a prostate cancer might grow or spread, and as a result, help decide what treatment options might be best and when they should be given. These tests look at which genes or proteins are active inside the prostate cancer cells. Examples of such tests include:

These tests continue to be studied to find more areas where they can be useful in prostate cancer risk and treatment decisions.

Treatment For Intermediate Risk Prostate Cancer

Intermediate risk prostate cancers are the most frequently treated prostate cancers. They are cancers that are confined to the prostate, often are Gleason 7 and have a PSA of less than 20. These cancers are treated in men with life expectancy greater than 10 years to prevent spread of the cancer in the long-term. There are a number of different effective treatment options for intermediate risk prostate cancer and the decision is often a personal one. Here at UCLA we recommend consultation with both Urologist and Radiation Oncologist to help men decide which treatment option is best for them.

National Comprehensive Cancer Network Recommendations

The NCCN guidelines for prostate cancer include 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 .

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 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

Metastatic CRPC with visceral metastases

Other secondary hormone therapy

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Nomograms And Predictive Models

Optimal treatment of prostate cancer requires assessment of risk: how likely is a given cancer to be confined to the prostate or to spread to the regional lymph nodes? How likely is the cancer to progress or metastasize after treatment? How likely is salvage with adjuvant radiation after an unsuccessful radical prostatectomy? Prostate cancers are best characterized by clinical stage determined based on DRE, Gleason score in the biopsy specimen, and serum PSA level. Imaging studies have been investigated intensively but have not been accepted as essential adjuncts to staging.

Predicting prognosis is essential for patient decision-making, treatment selection, and adjuvant therapy. These guidelines incorporate a risk stratification scheme that uses a minimum of stage, grade, and PSA to assign patients to risk groups. These risk groups are used to select the appropriate options that should be considered for treatment and to predict the probability of biochemical failure after definitive local therapy.7 This risk group stratification has been published widely and validated, and provides a better basis for treatment recommendations than clinical stage alone.8,9

Comparison Of Distribution Of Patient Characteristics Stratified By Whether Patient Was Upgraded To Prostatectomy Gleason 8 Or Higher

Adverse Pathologic Findings for Men Electing Immediate Radical ...

Clinicopathologic characteristics of the 136 included patients are presented in Table 1. The median age was 60.5 years, and the median pretreatment PSA was 5.8 ng/mL. Most men had clinical T1c disease. All of men had Gleason score 7, with 49.3% of these demonstrating Gleason 4 + 3 on biopsy. The median GPC was 70%. We observed that men who had pathologic upgrading at the time of RP were significantly older and had higher median GPC

Some Things To Consider When Choosing Among Treatments

Before deciding on treatment, here are some questions you may want to ask yourself:

Are you the type of person who needs to do something about your cancer, even if it might result in serious side effects?
Would you be comfortable with watchful waiting or active surveillance, even if it means you might have more anxiety and need more frequent follow-up appointments in the future?
Do you need to know right away whether your doctor was able to get all of the cancer out ? Or are you comfortable with not knowing the results of treatment for a while if it means not having to have surgery?
Do you prefer to go with the newest technology , which might have some advantages? Or do you prefer to go with better proven treatments that doctors might have more experience with?
Which potential treatment side effects might be most distressing to you?
How important for you are issues like the amount of time spent in treatment or recovery?
If your initial treatment is not successful, what would your options be at that point?

Many men find it very stressful to have to choose between treatment options, and are very fearful they will choose the âwrongâ one. In many cases, there is no single best option, so itâs important to take your time and decide which option is right for you.

Secondary Outcomes: Reclassification And Curative Intervention

In 467 men , disease was reclassified during biopsy at a median of 2.0 years after enrollment 233 involved grade reclassification, and 234 involved volume reclassification . At 5, 10, and 15 years after the start of surveillance, the cumulative incidence of any biopsy reclassification was 35%, 49%, and 56%, respectively, and the cumulative incidence of grade reclassification was 17%, 26%, and 31%, respectively .

Cumulative incidence of secondary outcomes: treatment , grade reclassification , and reclassification by grade or cancer extent .

Cumulative incidence of Gleason grade reclassification for men with very-low-risk prostate cancer and low-risk prostate cancer : all GR , GR to 3 + 4 , and GR to 4 + 3 and greater .

Treatment was recommended in the event of reclassification during biopsy. For those treated, intervention occurred at a median of 3.0 years after enrollment. One hundred nine men elected treatment in the absence of biopsy reclassification, whereas 361 men underwent treatment on the basis of biopsy reclassification . The cumulative incidence of treatment at 5, 10, and 15 years after the start of surveillance was 37%, 50%, and 57%, respectively . For the overall cohort, the median time during surveillance that was free of intervention was 8.5 years .

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Can Adt Compensate For Dose Escalation

The Prostate Cancer Study III examined the addition of ADT to SDRT and DERT in intermediate-risk patients . The preliminary results of this trial have now been published in abstract form. A total of 600 patients were enrolled. Intermediate-risk prostate cancer was defined as T1/T2 disease, GS 6, PSA level 1020 ng/mL or T1/T2 disease, GS of 7, PSA level 20 ng/mL. Patients were randomly assigned to one of three arms: 6 months of ADT plus 70 Gy to the prostate , 6 months of ADT plus 76 Gy , or 76 Gy alone . ADT consisted of bicalutamide and goserelin for 6 months. RT was delivered using a 3D conformal technique and started 4 months after the beginning of ADT. Median follow-up was 6.75 years. Primary endpoints were biochemical failure and disease-free survival . Secondary endpoints included OS, as well as hormonal and radiation-related toxicities. Biochemical failure was defined as 2 ng/mL above the PSA nadir.

Considering Prostate Cancer Treatment Options

Prostate Cancer (Part 1): Introduction to Low & Favorable-Intermediate Risk Prostate Cancer

For most men diagnosed with prostate cancer, the cancer is found while its still at an early stage its small and has not spread beyond the prostate gland. These men often have several treatment options to consider.

Not every man with prostate cancer needs to be treated right away. If you have early-stage prostate cancer, there are many factors such as your age and general health, and the likelihood that the cancer will cause problems for you to consider before deciding what to do. You should also think about the possible side effects of treatment and how likely they are to bother you. Some men, for example, may want to avoid possible side effects such as incontinence or erection problems for as long as possible. Other men are less concerned about these side effects and more concerned about removing or destroying the cancer.

If youre older or have other serious health problems and your cancer is slow growing , you might find it helpful to think of prostate cancer as a chronic disease that will probably not lead to your death but may cause symptoms you want to avoid. You may think more about watchful waiting or active surveillance, and less about treatments that are likely to cause major side effects, such as radiation and surgery. Of course, age itself is not necessarily the best reason for your choice. Many men are in good mental and physical shape at age 70, while some younger men may not be as healthy.

Primary Outcomes: Mortality And Metastasis

Of the 1,298 men who received follow-up, 49 died . Thirty-eight men died as a result of causes other than prostate cancer before reclassification or treatment, and nine men died as a result of causes other than prostate cancer after being treated for prostate cancer. Death occurred at a median age of 75.5 years , and the most common overall cause of death was cardiovascular disease. The 47 men who died as a result of causes other than prostate cancer were receiving AS for a median of 7.0 years before their deaths.

Outcome Measurements And Statistical Analysis

Complete information on PSA, PSA density , clinical stage, percentage of positive cores, percentage of maximum surface specimen involvement, and RP pathology were available. GS upgrade and downgrade, nonorgan-confined and nonspecimen-confined disease, unfavorable disease were the outcomes. Statistical analysis included descriptive statistics and multivariable logistic regression.

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Side Effects Of Surgery For Prostate Cancer

The most commonly experienced side effects of surgery for prostate cancer are urinary incontinence and erectile dysfunction.

According to the patient-reported outcomes from men who participated in the ProtecT trial, men who undergo a radical prostatectomy experience more sexual dysfunction and urinary problems than those treated with radiation therapy.

While many reported an improvement in the severity of their symptoms six months after surgery, these men continued to report poorer sexual quality of life six years after surgery compared to those who had radiation therapy.

While men treated with radiation reported experiencing bowel function problems after treatment, the men who had a prostatectomy were generally able to undergo the procedure without experiencing any changes in bowel function after surgery.

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Symptomatic treatment of an enlarged prostate usually involves a combination of medication and lifestyle changes. A diet rich in fruits and vegetables may be the best option if you suffer from chronic urination. It will help the body adjust to the increased size of the prostate. Also, taking regular urination intervals will help retrain the bladder to function properly. Inactivity also contributes to urine retention, and cold temperatures can increase the urge to urinate.

Invasive treatment of enlarged prostate includes medication that relieves the pressure on the urethra and bladder. However, if the condition is severe, it may require surgical intervention. If treatment is not successful, the enlarged prostate can become a potentially life-threatening disease. As the hormone levels in the body change, the enlarged prostate can lead to various complications, including urinary retention and even cancer. This is why it is critical to see a doctor for further evaluation.

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Bisphosphonates And Prostate Cancer

In men with castration-recurrent prostate cancer and bone metastases, zoledronic acid every 3 to 4 weeks is recommended to prevent disease-related skeletal complications, including pathologic fractures, spinal cord compression, surgery, or RT to bone . Other bisphosphonates are not known to be effective for preventing disease-related skeletal complications.

In a pivotal multicenter study, 643 men with castration-recurrent prostate cancer and asymptomatic or minimally symptomatic bone metastases were assigned randomly to intravenous zoledronic acid or placebo.170 All men continued ADT throughout the study and received additional antineoplastic therapy at the discretion of the investigator. The primary study end point was the proportion of men who experienced one or more skeletal-related event by 15 months. Adverse renal events prompted 2 study amendments. In the first amendment, the infusion time for zoledronic acid was increased from 5 to 15 minutes. In the second amendment, the zoledronic dose in the 8-mg treatment group was reduced to 4 mg, serum creatinine monitoring was implemented before each dose, and the primary efficacy assessment became the comparison of the 4-mg group versus placebo.

Psa Response And Biochemical Control

The overall 5-year actuarial FFBF for the whole group was 92.7% . Six patients out of the entire cohort of 142 patients, all in the low dose group, experienced BF two were high risk, three intermediate risk, and one low risk. The low-dose and high-dose groups median PSA nadirs were 0.3 and 0.1 ng/mL, respectively. Five year actuarial FFBF was 100% for the high dose group and 93.75% for the low dose group, p= 0.05, hazard ratio of 11.0 for low compared to high dose .

Table 2. Freedom from biochemical failure stratified by risk and descriptive statistics.

Figure 2. Years of freedom from biochemical failure by dose for all patients.

Figure 3. Years of freedom from biochemical failure by Gleason score for all patients.

Multivariate analysis evaluated the most significant factors in univariate analysis including risk stratification groups, GS, and dose. GS and dose were the most predictive factors in multivariate analysis but did not reach statistical significance at the p< 0.05 level. Of note, with only six failures, we only have the power to detect a single significant predictor of failure in the multivariate analysis.

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Ethics Approval And Consent To Participate

The database was closed for analysis in December 2018. This retrospective study was approved by Kitasato University Medical Ethics Organization . All methods were carried out in accordance with relevant guidelines and regulations. Informed consent was obtained in the form of opt-out in the web-site. Those who rejected were excluded.

Patient And Treatment Characteristics

Intermediate-Risk Prostate Cancer Treatment – MUSC Hollings

One hundred and forty-two consecutive patients were analyzed with pretreatment and treatment factors described in Table 1. NCCN risk groups are depicted in Table 1 with either three or five strata . Androgen deprivation therapy in the form of luteinizing hormone-releasing hormone agonist was used in 28.2% of patients . The use of ADT was dependent on individual urologist and radiation oncologist preference. Selected very low and low risk patients received ADT to shrink the prostate before SBRT.

Table 1. Patient and tumor characteristics.

Patients who received 35 or 36.25 Gy were termed the low-dose group and those who received 37.5 Gy the high-dose group. Most patients received their treatment over 58 days. The remainder completed treatment between 9 and 19 days with one non-compliant patient receiving his final fraction several weeks later, all due to poor adherence to their schedule. Treatment was delivered with an average of 187 non-coplanar beams. X-ray images were taken every three to five beams to track the prostates movement.

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I Have Heard That Other Factors May Be Included When Evaluating Treatment

Yes, other factors such as the number of biopsies and the presence of Gleason Score 7 versus a Gleason Score may influence the treatment decision. The number of + biopsies is also strongly predictive of outcomes but not typically part of the risk grouping systems. An example would be a person with a multiple + biopsies Gleason 7. His cancer would be considered a High Intermediate Risk and require a combination of External Beam and radiation while another patient with only a few + biopsies could be a Low Intermediate Risk patient and be a good candidate for an implant alone. These factors should be discussed with you doctor.

Treatment Protocol At Each Institution

Some patients receiving SEED-BT at institution A in 2006 were treated using preplanning methods. Most other patients at the 3 institutions were treated using an intraoperative planning method with modified peripheral loading techniques using a Mick applicator,. The therapeutic planning and post-implant dosimetric evaluation were performed using the Interplant planning system or Variseed . 125I was used for all patients. Either Oncoseed 6711 or STM 1251 was used for SEED-BT. The doses were defined using the TG-43 criteria. At 1 month after treatment with SEED-BT alone, a computed tomography-based dosimetric analysis was performed to calculate the D90, V100, and V150 results. Prostate D90 is the minimum dose to 90% of the prostate gland at 1 month. Prostate V100 and V150 are the percentages of the prostate gland volume respectively receiving 100% and 150% of the prescribed dose at 1 month. These treatment protocols were used at each institution:

Institution A

Institution B

Institution C

All patients classed as intermediate-risk were candidates for treatment with SEED-BT alone. Patients receiving SEED-BT alone were treated at a prescribed dose of 145 Gy. Non patients were treated with a combination of SEED-BT and EBRT. The CTV for SEED-BT included the entire prostate. No PTV was created in SEED-BT.

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