Md Anderson Cancer Center 93
This trial evaluated the effect of dose escalation from 70 to 78 Gy on freedom from failure, and was among the first to include biochemical freedom from failure as an endpoint. Between 1993 and 1998, 301 patients with T1T3 tumors, including 139 patients with intermediate-risk cancer, were randomized to receive 70 or 78 Gy via EBRT to the prostate gland. All patients received an initial 46 Gy in 2 Gy daily fractions via a four-field box technique. Following delivery of 46 Gy, each group received a 3DCRT boost commensurate with their remaining prescribed total dose, such that the conventional dose arm received an additional 24 Gy via a four-field technique, and the high-dose arm received a 32 Gy boost via a six-field technique. At 8-year follow up, freedom from biochemical failure favored the 78 Gy arm, 59% versus 78% . The subset of patients with an initial PSA of more than 10 ng/ml gained the greatest benefit from dose escalation with 78% versus 39% freedom from failure . Among patients with intermediate-risk cancer, the subset with pretreatment PSA greater than 10 ng/ml similarly benefitted most substantially from dose escalation, with biochemical freedom from failure of 94% versus 65%
Notably, the rate of Radiation Therapy Oncology Group grade 2 or greater rectal toxicity was 14% higher in the 78 Gy arm and was found to correlate with the volume of rectum receiving at least 70 Gy
How Prostate Cancer Is Treated
In cancer care, different types of doctorsincluding medical oncologists, surgeons, and radiation oncologistsoften work together to create an overall treatment plan that may combine different types of treatments to treat the cancer. This is called a multidisciplinary team. Cancer care teams include a variety of other health care professionals, such as palliative care experts, physician assistants, nurse practitioners, oncology nurses, social workers, pharmacists, counselors, dietitians, physical therapists, and others.
The common types of treatments used for prostate cancer are described below. Your care plan may also include treatment for symptoms and side effects, an important part of cancer care.
Treatment options and recommendations depend on several factors, including the type and stage of cancer, possible side effects, and the patients preferences and overall health.
Cancer treatment can affect older adults in different ways. More information on the specific effects of surgery, chemotherapy, and radiation therapy on older patients can be found another section of this website.
Because most prostate cancers are found in the early stages when they are growing slowly, you usually do not have to rush to make treatment decisions. During this time, it is important to talk with your doctor about the risks and benefits of all your treatment options and when treatment should begin. This discussion should also address the current state of the cancer:
The Natural History And Molecular Biology Of Low Grade Prostate Cancer
Prostate cancer develops with age in the majority of men, including those from all races and regions. In Caucasians, the chance of harboring prostate cancer is approximately the same as ones age thirty percent of men in their 30s, 40% in their 40s, 80% in their 80s . Most of these are microfoci and low grade, particularly in younger men. The high prevalence of microfocal prostate cancer has been confirmed in autopsy studies of Caucasians, Asians, and other ethnic groups going back more than 50 years. A recent autopsy study in Japanese and Russian men who died of other causes showed that overall 35% of both groups had prostate cancer, and 50% of the cancers in Japanese men aged > 70 were Gleason score 7 or above .
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Hypofractionation Stereotactic Body Radiation Therapy And High
Hypofractionation for the treatment of prostate cancer has recently experienced renewed interest based on radiobiological properties of tumor cells and resultant theoretical improvements in the therapeutic ratio with increased fraction sizes. While most tumors have / ratios around 8, prostate cancer cells are postulated to have an / ratio of 2. As the rectum is the major dose-limiting structure for the delivery of radiation to the prostate, and has a higher / ratio estimated at 46, it follows that hypofractionation should permit greater tumor killing without an attendant increase in the incidence of late toxicity . Several randomized and nonrandomized trials have demonstrated the feasibility, tolerability, and noninferiority of hypofractionated regimens .
In a representative single institution series from the Cleveland Clinic, 770 patients received 70 Gy over 28 fractions via an IMRT technique. At 45 months of median follow up biochemical control rates were 94% in low-risk, 83% in intermediate-risk, and 72% in high-risk groups. There was no increase in acute or late GI or GU toxicity .
Based on the same radiobiological principles, and in concert with the development of emerging technologies and patient preferences, limited initial single institution experiences with stereotactic body RT and high-dose rate monotherapy approaches to extreme hypofractionation have shown promising results but require further evaluation .
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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The Staging Grading And Prognosis Of Prostate Cancer
Staging
The tests completed by your specialist help work out whether you have prostate cancer and if it has spread to other parts of your body. This process is called staging. It helps you and your health care team decide which management or treatment option is best for you.
The most common staging system for prostate cancer is the TNM system. In this system, letters and numbers are used to describe the size of the tumour , whether the cancer has spread to nearby lymph nodes , and whether the cancer has spread to the bones or other organs, i.e. whether it has metastasised . The TNM scores are combined to work out the overall stage of the cancer, with higher numbers indicating larger size or spread.
| localised stages 12 | The cancer is contained inside the prostate. |
|---|---|
| locally advanced stage 3 | The cancer is larger and has spread outside the prostate to nearby tissues or nearby organs such as the bladder, rectum or pelvic wall. |
| advanced stage 4 | The cancer has spread to distant parts of the body such as the lymph glands or bone. This is called prostate cancer even if the tumour is in a different part of the body. |
Grade and risk category
The biopsy results will show the grade of the cancer. This is a score that describes how quickly the cancer may grow or spread.
Risk of progression
Prognosis
Prognosis means the expected outcome of a disease. You may wish to discuss your prognosis with your doctor, but it is not possible for anyone to predict the exact course of the disease.
If Treatment Does Not Work
Recovery from cancer is not always possible. If the cancer cannot be cured or controlled, the disease may be called advanced or terminal.
This diagnosis is stressful, and for some people, advanced cancer may be difficult to discuss. However, it is important to have open and honest conversations with your health care team to express your feelings, preferences, and concerns. The health care team has special skills, experience, and knowledge to support patients and their families and is there to help. Making sure a person is physically comfortable, free from pain, and emotionally supported is extremely important.
People who have advanced cancer and who are expected to live less than 6 months may want to consider hospice care. Hospice care is designed to provide the best possible quality of life for people who are near the end of life. You and your family are encouraged to talk with the health care team about hospice care options, which include hospice care at home, a special hospice center, or other health care locations. Nursing care and special equipment, including a hospital bed, can make staying at home a workable option for many families. Learn more about advanced cancer care planning.
After the death of a loved one, many people need support to help them cope with the loss. Learn more about grief and loss.
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Remission And The Chance Of Recurrence
A remission is when cancer cannot be detected in the body and there are no symptoms. This may also be called having no evidence of disease or NED.
A remission can be temporary or permanent. This uncertainty causes many people to worry that the cancer will come back. Although there are treatments to help prevent a recurrence, such as hormonal therapy and radiation therapy, it is important to talk with your doctor about the possibility of the cancer returning. There are tools your doctor can use, called nomograms, to estimate someone’s risk of recurrence. Understanding your risk of recurrence and the treatment options may help you feel more prepared if the cancer does return. Learn more about coping with the fear of recurrence.
In general, following surgery or radiation therapy, the PSA level in the blood usually drops. If the PSA level starts to rise again, it may be a sign that the cancer has come back. If the cancer returns after the original treatment, it is called recurrent cancer.
When this occurs, a new cycle of testing will begin again to learn as much as possible about the recurrence, including where the recurrence is located. The cancer may come back in the prostate , in the tissues or lymph nodes near the prostate , or in another part of the body, such as the bones, lungs, or liver . Sometimes the doctor cannot find a tumor even though the PSA level has increased. This is known as a PSA recurrence or biochemical recurrence.
Focal Therapy For Prostate Cancer
With recent advances in MRI and targeted biopsy, we are better able to locate the exact area of prostate cancer. Men who do not have an enlarged prostate, who have prostate cancer that is detected only in a single region of the prostate and have intermediate grade cancer can be a candidate for focal therapy. This type of therapy treats only the cancerous tissue and spares the normal prostate, thereby preserving urinary and sexual function
Here at UCLA we commonly use cryotherapy or HIFU to focally treat prostate cancer. Given that this is a relatively new form of treatment, we have established rigorous post-treatment protocols using MRI and biopsies to ensure that the cancer has been adequately treated.
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Modifying Risk Level Classification
The new millennium brought changes as 1) more epidemiological and demographic data accumulated, 2) the nature of PCa was better understood, and 3) sub-radical therapies such as focal ablation or hemi-ablation were developed to offer comparable cancer control but with far fewer side effect risks. A need was seen to add qualifiers to low risk PCa. Thus, the National Comprehensive Cancer Network subdivided this category into very-low and low-risk types to help doctors and patients determine for which men Active Surveillance or a sub-radical treatment would be safe choice.
The NCCN system did not qualify intermediate risk PCa. It differs a bit from DAmico, defining it as stage T2b or T2c, Gleason score of 7, and PSA level 10-20 ng/mL. However, by 2015 it was clear that this category was the largest group of PCa cases with the most heterogeneous disease characteristics. There was a wide range of PCa-specific mortality as well as biochemical or clinical recurrence after radical treatment by prostatectomy, beam radiation, and brachytherapy . Studies began to show that all Gleason 7 is not created equal men with Gleason 3+4=7 had better outcomes than those with Gleason 4+3=7, Therefore, In order to better understand this risk group, new classification systems have been proposed that help reduce its heterogeneity by subdividing men with intermediate-risk prostate cancer into favorable and unfavorable subgroups.
About Dr Dan Sperling
Dan Sperling, MD, DABR, is a board certified radiologist who is globally recognized as a leader in multiparametric MRI for the detection and diagnosis of a range of disease conditions. As Medical Director of the Sperling Prostate Center, Sperling Medical Group and Sperling Neurosurgery Associates, he and his team are on the leading edge of significant change in medical practice. He is the co-author of the new patient book Redefining Prostate Cancer, and is a contributing author on over 25 published studies. For more information, contact the Sperling Prostate Center.
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Experiences With Active Surveillance In Patients With Expanded Selection Criteria
The number of men with features of intermediate risk prostate cancer who are currently offered AS is unknown. Non-curative management is initially recorded for around 14% of men with intermediate risk disease features within the SEER and National Cancer Database, however these datasets are unable to distinguish AS with defined surveillance strategies from traditional watchful waiting or just deferred treatment to the prostate. Within the Swedish Prostate Cancer Registry, however, active surveillance was recorded as initial treatment choice for 16% of intermediate risk men. At this time, most intermediate risk men in the Western world are offered curative therapy at the time of diagnosis. Several investigators have published their experiences of surveillance with delayed intervention for men with intermediate risk disease. Different patient selection criteria and surveillance strategies are described. The âintermediate riskâ category is defined differently for each of the studies analyzed . Another confounder is the modification of the Gleason scoring system over time. The International Society of Urologic Pathology update to prostate cancer grading in 2005 resulted in upgrading of many pattern 3s to pattern 4, or 6 to 7. Certain low-risk patients included in series prior to 2005 without contemporary pathologic review, therefore may actually be similar to contemporary men with Gleason 3+4 tumors.
What Affects My Treatment Options
Your treatment options will depend on whether your cancer is contained within the prostate gland , has spread just outside of the prostate or had spread to other parts of the body .
You may have a choice of treatments. Your doctor or specialist nurse will explain all your treatment options, and help you to choose the right treatment for you.
Your treatment options and which treatment you choose may depend on several things, including:
- how far your cancer has spread
- how quickly your cancer may be growing
- the advantages and disadvantages of each treatment
- what each treatment involves
- the possible side effects of each treatment
- practical things, such as how often you would need to go to hospital, or how far away your nearest hospital is
- your own thoughts about different treatments
- how the treatment you choose now could affect your treatment options later if your cancer comes back or spreads
- your general health
- how long youre expected to live for.
The first treatment you have may affect which treatments you can have in the future, if you need further treatment. Speak to your doctor or nurse about this.
It can help to write down any questions you want to ask at your next appointment. And to take someone to appointments, such as your partner, friend or family member.
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Pretreatment Evaluation Of Patients With Intermediate
In addition to routine history and physical examination, including a digital rectal examination, serum PSA, and serum testosterone, radiographical imaging of the abdomen and pelvis using computed tomography or magnetic resonance imaging should be obtained to assist in the evaluation of the extent of primary disease. Although the likelihood of bone metastases is low in men with intermediate-risk prostate cancer, bone scan may be appropriate for patients in whom there is high suspicion for metastatic disease based on laboratory, imaging, or clinical findings .
While CT imaging of the pelvis is the current standard, T2 MRI is superior to CT as it provides adequate soft tissue resolution to delineate the anatomy of the prostate, seminal vesicles, neurovascular bundles, and pelvic floor. MRI offers the ability to detect disease within and adjacent to the prostate gland that is not as easily visualized on CT . MRI, if obtained, can be fused to treatment planning CTs, allowing improved accuracy in contour definition of target and normal tissue volumes . This may result in improved clinical outcomes by decreasing normal tissue toxicity . MRI and magnetic resonance spectroscopy may have a role in the evaluation of tumor response to external beam radiation therapy and prostate brachytherapy .
Radiation Therapy Oncology Group 94
This multi-institutional study was conducted to evaluate the effect of the addition of AST to RT on overall survival, freedom from biochemical failure, freedom from clinical progression, and disease-free survival in patients with localized prostate cancer in response to the positive effect on these parameters seen in RTOG 86-10. To this end, 1979 patients with T1bT2b prostate cancer and PSA less than 20 ng/ml were randomized to receive EBRT alone or in conjunction with 2 months of neoadjuvant and 2 months of concurrent goserelin and flutamide.
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Two Studies For Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment For Patients With A Low Gene Risk Score And Testing A More Intense Treatment For Patients With A Higher Gene Risk Score
| The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| First Posted : September 20, 2021Last Update Posted : September 8, 2022 |
PRIMARY OBJECTIVES:
I. To determine whether men with National Comprehensive Cancer Network unfavorable intermediate risk prostate cancer and lower Decipher genomic risk treated with radiation therapy alone instead of 6 months androgen deprivation therapy + RT experience non-inferior rate of distant metastasis. II. To determine whether men with NCCN UIR prostate cancer who are in the higher genomic risk will have a superior metastasis-free survival through treatment intensification with darolutamide added to the standard of RT plus 6 months ADT.
SECONDARY OBJECTIVES:
I. To compare overall survival between the standard of care and either the de-intensification or intensification interventions.
II. To compare time to prostate specific antigen failure between the standard of care and either the de-intensification or intensification interventions.
EXPLORATORY OBJECTIVES:
OUTLINE:
Inclusion Criteria: