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.
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Cabazitaxel In Later Lines Of Therapy For Mcrpc
The panel also discussed results of the multicenter, randomized, open-label CARD study, which compared cabazitaxel with either abiraterone or enzalutamide in 255 patients with metastatic CRPC who had previously received docetaxel and either abiraterone or enzalutamide.21 Either order of the previously received therapies was allowed, and abiraterone or docetaxel could have been given in the castration-naÃ¯ve setting. Disease progression on abiraterone or enzalutamide had to have occurred within 12 months for patients to be eligible. Cabazitaxel at 25 mg/m2 with concurrent steroid improved the primary endpoint of radiographic PFS and reduced the risk of death compared with abiraterone or enzalutamide in these patients . Cabazitaxel was also associated with an increased rate of pain response and delayed time to pain progression and skeletal-related events.22
Panel consensus was that results of CARD provide level 1 evidence supporting cabazitaxel over abiraterone or enzalutamide in patients who have already received docetaxel and either abiraterone or enzalutamide. Therefore, the panel included cabazitaxel as a category 1, preferred option for patients with prior docetaxel and prior novel hormone therapy in the metastatic CRPC setting .
Lantheus Announces Updates To The Nccn Guidelines For Psma Pet Imaging For Prostate Cancer
PYLARIFY® injection was the first commercially available PSMA-targeted PET imaging agent for prostate cancer
NORTH BILLERICA, Mass. — Lantheus Holdings, Inc. , an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced that both the National Comprehensive Cancer Network and the Society of Nuclear Medicine and Molecular Imaging have now updated their guidelines for the use of prostate specific membrane antigen positron emission tomography imaging. Both the NCCN guidelines and the SNMMI appropriate use criteria note that all approved PSMA PET imaging agents, including PYLARIFY® , may be used for patient selection for PSMA-targeted radioligand therapy.
We are pleased that the NCCN and SNMMI have now both updated their guidelines to include PYLARIFY, the most widely adopted PSMA PET imaging agent, for patient selection for PSMA-targeted lutetium radioligand therapy, said Bela Denes , MD, Lantheus Vice President of Medical Affairs. We believe this will increase the accessibility to PSMA-targeted therapeutics for patients with advanced disease and further validates the benefit and utility that PYLARIFY provides to the U.S. prostate cancer community.
- with suspected metastasis who are candidates for initial definitive therapy.
- with suspected recurrence based on elevated serum prostate-specific antigen level.
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What You Need To Know About The Prostate Nccn Favorable Intermediate Risk Prostate Cancer
A enlarged prostate can also cause blockages in the urethra. A blocked urethra can also damage the kidneys. A patient suffering from an enlargement of the prostate may have pain in his lower abdomen and genitals. If pain is present, a digital rectal examination will reveal hard areas. A doctor may prescribe surgery or perform an endoscopic procedure. If the enlarged prostate is not completely removed, it will shrink.
While the size of an enlarged prostate will influence the extent of urinary symptoms, men may experience a range of urinary symptoms. Some men have minimal or no symptoms at all. Some men will have a very enlarged prostate, whereas others will have a mild enlargement. Generally, the symptoms can stabilize over time. Some men may have an enlarged prostate but not notice it. If they have an enlarged colon, their physician can perform a TURP procedure.
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American Society Of Clinical Oncology/cancer Care Ontario Recommendations
ASCO and CCO released a joint clinical practice guideline for treatment of men with metastatic CRPC in 2014. The guideline recommendations include the following :
Pharmacologic androgen deprivation therapy should be continued indefinitely
Offer patients one of three treatment optionsabiraterone/prednisone, enzalutamide, or radium-223 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 drugâs limited clinical benefit and side effect risk
Do not offer the drugs bevacizumab , estramustine, or sunitinib
Begin discussion of palliative care early on while discussing treatment options
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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.
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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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Secondary Hormone Therapy For Crpc
Most men with advanced disease eventually stop responding to traditional ADT and are categorized as castration-resistant . Research has shown enhancement of autocrine and/or paracrine androgen synthesis in the tumor microenvironment of men receiving ADT.166,167 Androgen signaling consequent to nongonadal sources of androgen in CRPC refutes earlier beliefs that CRPC was resistant to further hormone therapies. The development of novel hormonal agents demonstrating efficacy in the metastatic CRPC setting dramatically changed the paradigm of CRPC treatment.
For men who develop CRPC, ADT with an LHRH agonist or antagonist should be continued to maintain castrate serum levels of testosterone . Options for secondary hormone therapy include a first-generation antiandrogen, antiandrogen withdrawal, ketoconazole with or without hydrocortisone, corticosteroid, diethylstilbestrol , or other estrogen.168,169 However, none of these strategies has yet been shown to prolong survival in randomized clinical trials. New secondary hormone options include abiraterone , enzalutamide , and apalutamide , as discussed subsequently.
Evidence For Mpmri And Tumor Multigene Molecular Testing
The role of mpMRI in the diagnosis of prostate cancer has become increasingly important in recent years, as reflected in the NCCN and other prostate cancer guidelines.4 mpMRI typically includes diffusion-weighted imaging and/or dynamic contrast-enhanced images in addition to the standard anatomical T2-weighted imaging. The quality mpMRI involves a 3 T magnet. It has a higher signal to noise ratio, allowing quality imaging within a short time and without the use of an endorectal coil .
The NCCN guideline recommendations are based on evidence reviewed and voted on by the guideline panels. This evidence is eventually published in the Discussion section of the guidelines. However, because the NCCN guideline on prostate cancer is updated so frequently, the Discussion section often lags behind the recommendations within the same guideline. In Version 2.2022 , for example, the Discussion section is dated November 17, 2020. Many of the recent updates related to the implementation of mpMRI have been based on its increased availability and ability to stage and characterize prostate cancer.
The NCCN recommendation to use tumor molecular testing is based on the goal of achieving personalized or precision medicine. Molecular testing of a tumor offers the potential to evaluate the biologic behavior of a cancer, which would aid in clinical decision making, the guideline says.
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European Association Of Urology/european Society For Radiotherapy And Oncology/international Society Of Geriatric Oncology Recommendations
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 :
Treat with life prolonging agents . 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.
Individuals Who Provided Content Development And/or Authorship Assistance:
Edward Schaeffer, MD, PhD, Panel Chair, has disclosed that he is a scientific advisor for AbbVie, Inc., and Janssen Scientific Affairs, LLC.
Sandy Srinivas, MD, Panel Vice Chair, has disclosed that she is a scientific advisor for Bayer HealthCare, and receives grant/research support from Bayer HealthCare, Endocyte, and Exelixis Inc.
Emmanuel S. Antonarakis, MD, Panel Member, has disclosed that he has received consulting fees from Amgen Inc., Astellas Pharma US, Inc., AstraZeneca Pharmaceuticals LP, Clovis Oncology, Dendreon Corporation, Eli Lilly and Company, GlaxoSmithKline, Janssen PharmaceuticaProducts, LP, Medivation, Inc., Merck & Co., Inc., and ESSA Pharma, Inc. received grant/research support from AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Dendreon Corporation, Genentech, Inc., Janssen PharmaceuticaProducts, LP, Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Tokai, and sanofi-aventis U.S. and receives royalty income from Qiagen.
Xin Gao, MD, Panel Member, has disclosed that he has received honoraria from Exelixis Inc.
George Netto, MD, Panel Member, has disclosed that he has no relevant financial relationships.
Daniel E. Spratt, MD, Panel Member, has disclosed that he receives grant/research support from Janssen PharmaceuticaProducts, LP.
Dorothy A. Shead, MS, Senior Director, Patient Information Operations, NCCN, has disclosed that she has no relevant financial relationships.
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Agents Related To Bone Health In Crpc
In a multicenter study, 643 men with CRPC and asymptomatic or minimally symptomatic bone metastases were randomized to intravenous zoledronic acid every 3 weeks or placebo.228 At 15 months, fewer men in the zoledronic acid 4-mg group than men in the placebo group had SREs . An update at 24 months also revealed an increase in the median time to first SRE .229 No significant differences were found in OS. Other bisphosphonates have not been shown to be effective for prevention of disease-related skeletal complications. Earlier use of zoledronic acid in men with castration-naïve prostate cancer and bone metastases is not associated with lower risk for SREs, and in general should not be used for SRE prevention until the development of metastatic CRPC.230
The randomized TRAPEZE trial used a 2×2 factorial design to compare clinical PFS as the primary outcome in 757 men with bone metastatic CRPC treated with docetaxel alone or with zoledronic acid, 89Sr, or both.231 The bone-directed therapies had no statistically significant effect on the primary outcome or on OS in unadjusted analysis. However, adjusted analysis revealed a small effect for 89Sr on clinical PFS . For secondary outcomes, zoledronic acid improved the SRE-free interval and decreased the total SREs compared with docetaxel alone.
Enzalutamide In M0 And M1 Crpc
On August 31, 2012, the FDA approved enzalutamide, a next-generation antiandrogen, for treatment of men with metastatic CRPC who had received prior docetaxel chemotherapy. Approval was based on the results of the randomized, phase 3, placebo-controlled trial .186,187 AFFIRM randomized 1,199 men to enzalutamide or placebo in a 2:1 ratio, and the primary endpoint was OS. Median survival was improved with enzalutamide from 13.6 to 18.4 months . Survival was improved in all subgroups analyzed. Secondary endpoints also were improved significantly, which included the proportion of men with > 50% PSA decline , radiographic response , radiographic PFS , and time to first skeletal related event . QOL measured using validated surveys was improved with enzalutamide compared with placebo. Adverse events were mild and included fatigue , diarrhea , hot flushes , headache , and seizures . The incidence of cardiac disorders did not differ between the arms. Enzalutamide is dosed at 160 mg daily. Patients in the AFFIRM study were maintained on GnRH agonist/antagonist therapy and could receive bone supportive care medications. The seizure risk in the enzalutamide FDA label was 0.9% versus 0.6% in the manuscript.186,188
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Arent Nomograms More Predictive Of Prognosis
Nomograms are mathematical models used to attempt to individualize prognosis for individual patients. They use the PSA, stage and grade to predict results of various treatments. But nomograms are only as good as the data that is entered into them. For example, the current MSKCC nomogram for brachytherapy is VERY outdated. It includes patients Dr. Grimm treated from 1988-1990, but not his more recent patients with modern techniques. This data is incorrectly compared to updated surgical data. It is well recognized that within all treatment regimens the results have improved over the past 15 years primarily because the patients are diagnosed earlier and that the treatments are improved. Dr. Steven Frank at MD Anderson reported on the expected results of the MSKCC nomogram for brachytherapy compared to modern brachytherapy results and found the nomogram extremely inaccurate. Article
Thus, using the current MSKCC nomogram to compare surgical versus brachytherapy outcomes is extremely misleading. Therefore, rather than using a dated nomogram to decide on treatment, instead, look at modern results. Prostate Cancer Results Study Group
Other Ways To Measure Risk Of Prostate Cancer Growing And Spreading
In addition to the risk groups above, doctors are still learning about the best use of other types of tests and prognostic models to help decide the most effective treatment options for someone. If your doctor suggests using one of these ways to help determine your treatment options, have them explain what it can tell you, as well as how accurate its likely to be.
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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.
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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