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2008 Conference

State of the Art Treatments
for Early Stage and Relapsed Prostate Cancer

Sheraton Gateway - Los Angeles Airport
California, USA
September 6-7, 2008

Conference Summary
by Jim O’Hara, PCRI Educational Facilitator

PCRI wishes to say “Thank You” to all of the sponsors, speakers, volunteers, producers, and most of all, to the attendees who joined together to make the 2008 conference successful. Over 800 people representing 40 states and 10 countries (from 5 continents) participated in the lectures, discussions and exhibits.

“Remarkably well-organized, evidenced-based, affordable, and comprehensive.”

“The caliber of speakers and info far exceeded expectations.”

“We are truly blessed to have such a fine dedicated caring smart group of doctors”

“Overall- A+ meeting! Thank you all for creating a weekend to learn, share and meet other survivors.”

“Thank you to all the speakers, organizers and staff. It is a lot of work, but this is a unique opportunity for patients to get direct information from top clinicians and researchers specializing in PC.”

“The banquet was great, enjoyed the keynote speaker.”

The conference theme - “State of the Art Treatments for Early Stage and Relapsed Prostate Cancer” echoed PCRI’s new initiative “What’s Your Type?”. The speakers presented a fast-paced, in-depth update of 13 topics in a language that most of the audience could understand. After most of the talks, the speaker was available for questions in the Exhibit Hall. Attendees received a data CD with speaker slides for later review.

Around 100 attendees enhanced their experience by participating in support group sessions conducted by Us TOO during lunch on Saturday and Sunday. Separate groups convened to discuss topics on “General Prostate Cancer”, “Advanced Disease” and “Companions & Family” during each time slot. Our thanks to Jack Hudspeth, Chuck Maack, Ralph Valle, and Elizabeth Cabalka for facilitating these sessions. Also, thanks to Betty Gallo for conducting a special session for “Women and Prostate Cancer” on Sunday morning. Comments about the groups included:

“It was really nice to have someplace I could come, talk and sort through all I’m learning. The conference speakers are terrific but I am a bit overwhelmed with all the information. I just need someplace to connect.”

“This group made for a nice place to talk about all I am learning.”

“I really needed some place to share my feelings and fears.”

“So much great data this weekend! Thanks for making a place where we could all talk about it.”

“Thank you for recognizing that we (women) are deeply impacted by prostate cancer too.”

Over 50 medical professionals participated in a CME program sponsored by Community Memorial Hospital of Ventura.

The Gala Dinner on Saturday evening was a major highlight of the conference. Dean Jones, star of movies and stage, entertained as Master of Ceremonies. Attendees were inspired by the introductions of the Harry Pinchot Award Winners (see separate article). Dr. Peter Diamandis (of the X Prize Foundation) gave a mind-altering keynote address on a theme “with innovation and teamwork, anything is possible”.

 

Highlights of the Talks with Comments from Attendees

SATURDAY

The conference was opened with the first “Harry Pinchot Memorial Lecture”, which was made possible by a generous grant from Cancer Care Consultants.

Dietary Supplements from A-Z, What Works and What's Worthless
“Awesome presentation with excellent advice.”
Dr. Mark Moyad’s first point was that despite the risks of prostate cancer, controlling cardiovascular disease should still be a primary concern. “Heart healthy” promotes health for many bodily functions. Exercise is the best (and cheapest) way to improve overall health, reduce the need for pharmaceuticals and prevent premature death.

Exercise can reduce:
• Premature death=30-50%
•Heart disease=40-50% Stroke=30-50%
•Type II diabetes=30-40%
•BREAST CANCER=20-30%
•Colon cancer…=30-50%
•Osteoporosis=40-50%
•Depression=50%
•Kidney stones, E.D., Prostatitis, & FATAL P.C.!!

Everyone probably needs a vitamin D(3) supplement, but the dosage should be determined by a (25 [OH]-vitamin D) blood test. Some other suggestions included: increase soluble fiber, reduce belly fat, use aspirin only if needed, consider the need for supplements including calcium, ground flax seed, fish oil, etc.

Active Surveillance – An Alternative Strategy - Over detection, but selective treatment
“Very professional. So knowledgeable. Fantastic physician.”
Dr. Peter Carroll discussed the reasons and criteria for increased use of “active surveillance”. Widespread, repeated PSA testing and extended-core prostate biopsy have led to the possible over-detection of prostate cancer, This results in finding cancers which, would not be become clinically significant, if left untreated. Currently, over-detection rates are estimated to be between 27% and 56%. Despite such stage migration and the increasing risk of over-detection, active treatment is more common today than previously. Surveillance in low risk patients is feasible and associated with a low risk of progression.

UCSF has an “Active Surveillance” program with entry criteria of: PSA<10; Gleason sum ≤ 6, no pattern 4/5; Stage T1-T2; ≤ 33% cores positive, ≤ 50% any single core positive. A well-performed biopsy by an experienced Urologist is essential. Treatment is suggested at “Progression” defined as: PSA velocity >0.75 ng/ml/yr; Rise in Gleason score; Increase lesion size on ultrasound; PSA DT increase. Data to date includes: Median time to treatment for 24% of men: 3 years (range 1-17 years); 71% of treated men had evidence of clinical progression. Conclusions: Active surveillance appears feasible; Change in Gleason grade is greatest driver of treatment.

Active Surveillance - Patient Selection and Results
“His added humor was much appreciated.”
Dr. John Davis, pinch-hitting for Dr. Babaian, continued the topic with details of two studies and a discussion of patient and physician anxieties. He reviewed the “Active Surveillance program at M.D. Anderson that includes four groups of patients based on risk profile. The ideal patient is Very low risk: Gleason score (GS) <6 (3+3), no more than one positive core with <3-mm tumor, and PSA level <4 ng/mL (adjusted for age and prostate volume) He also discussed the evidence for the use of the PCA3 urine assay in selecting candidates for active surveillance and for monitoring changes that might suggest a need to treat the disease.

Focal Cryotherapy: Cancer Control and Potency Preservation
“Always relevant and intelligent…this year's talk had more info and relevancy to me.”
Dr. Duke Bahn discussed a compromise between active surveillance and radical treatment, using cryotherapy to destroy the focus of cancer only (Index Tumor). He presented data from three leading cryotherapy centers with mean follow-up on focal cryo of 28, 40 and 70 months. The data includes: stable PSA 84-95%, potency preservation 71-89% with no other significant complications reported. Dr. Bahn also explained a new clinical trial (called “Critical” Trial) combining cryotherapy and immunotherapy. The trial features the injection of a known number of patients’ own immature dendritic cells into his cryoablated prostate. Low dose cyclophosphamide is administered pre- and post-cryoablation to temporarily reduce regulatory T cells. The trial is open for accrual.

Essential Nutrition for Prostate Health
“Verne Varona's presentation was worth the price of admission.”
Verne Varona described the nutritional causes of inflammation which may contribute to many conditions, including cancer. He suggested exercise, and a diet with reduced pro-inflammatory foods such as: excessive amounts of animal and dairy protein, sugar, fat and artificial food chemicals, especially artificial sweeteners. He also suggested reduced consumption of "nightshade vegetables" (such as tomatoes, potatoes, eggplant and pepper family - particularly for those with joint pain) and alcohol (in his opinion a strong inflammatory and immune weakening agent). He discussed how each of these impacts body functions and can lead to various diseases. He provided several ideas for food exchanges and a dietary template consisting of: 25-35% whole grains, 35-40% vegetables and 5-15% of seven other categories including: animal protein, fruits, nuts, beans and a discreet amount of "WYW" (Whatever You Want). He concluded with 10 lifestyle recommendations:

1. Morning Skin Brushing for Promoting Lymph Flow
2. Daily Aerobic Exercise (Walking, Biking etc.) for at least 1/2 Hour
3. Eat More Frequently - Up to 4 Times Daily, Minimum
4. Control Food Volume - Consume 80% Of Appetite Capacity
5. Chew Thoroughly - Complex Carbohydrate First Digests in Your Mouth
6. Sip Hot Non-Caffeinated Tea After Meals
7. Have Meditative or Creative Time Daily
8. Do No Eat Prior to Bed for a Minimum of Three Hours
9. Do 3-4 simple Yoga Postures Before bedtime
10. Redefine Your Passions and Pursue Them

State-of-the-Art Scanning for Prostate Cancer
“Thank you for explaining why the FDA can be "slow" to approve a new tech. or drug.”
Dr. Daniel Margolis explained that the detection of prostate cancer is done through physical exam and blood PSA levels, followed by ultrasound guided biopsies. However, these techniques may not accurately determine where and how much cancer there is. New medical imaging techniques, especially MRI, are very sensitive for the localization and characterization of prostate cancer, and can provide important information when active surveillance is pursued, or when definitive treatment by surgery or radiation is planned. Current MRI techniques can evaluate anatomy, cellular density, cancer-associated metabolites, and blood flow dynamics with a combined accuracy of 93%. New techniques on the horizon show promise for detecting spread to lymph nodes and elsewhere. These include a new MRI imaging agent that mimics testosterone and another that contains a genetically engineered virus.

Intermittent Androgen Deprivation for PSA Recurrence after Initial Local Therapy
“Fabulous speaker and content.” “Bring him back please”
Dr. Stephen Strum started by emphasizing the importance of understanding that Biology is the key. Biology dictates cellular behavior and yields clues to Diagnosis & Staging, Tumor Volume & Aggressiveness and to Probability of Recurrence. Biological profile of PC forecasts the nature of a recurrence and relates to whether androgen deprivation (ADT) & Intermittent Androgen Deprivation (IAD) will work (or not). He discussed IAD as a major option for many patients who are found to have PSA recurrence (PSAR) after local therapy. It can also be a major first treatment option as primary androgen deprivation therapy for those who wish to minimize the treatment side effects of continuous ADT. IAD allows for the recovery of physiologic levels of testosterone, a key hormone that mediates a multitude of biological actions to maintain optimal health in such areas as musculo-skeletal integrity, red blood cell production, cognitive function, and of course libido and sexual performance. Dr. Strum covered the rationale for using IAD in the setting of PSAR and also what form of ADT as part of the IAD approach should be used (ADT1 vs ADT2 vs ADT3). He reviewed the data that supports adding Proscar® to extend the off-cycle. He reviewed the biologic parameters (like testosterone, a PSA nadir < 0.05 and other biomarkers) that should be used to guide the optimal use of IAD.

Treating Relapsed Disease without Hormonal Therapy
“First rate in all respects.”
Dr. Mark Scholz discussed recent research findings that men with relapsed prostate cancer can respond to certain agents with limited side-effects. Some of these treatments seem to work by a mechanism that harnesses the immune system. He discussed three approaches to stimulating the immune system individually or in combinations:

1) General stimulation of the immune system with Leukine® (originally developed to counteract the suppressive effect of chemotherapy on the immune system).
2) Reversing cancer-induced immune suppression using low-dose of Cytoxan® to suppress the regulatory immune system. CTLA-4 (ipilimumab) and Ontak® may also be beneficial in this area.
3) Improving recognition of non-self proteins via dendritic cells – VEGF is abundantly expressed by tumor cells and inhibits the development of dendritic cells. Over expression of COX-2 stimulates production of VEGF. COX-2 inhibitors (ex: Celebrex®) reduce VEGF. Thalidomide also blocks VEGF.

Dr. Scholz also presented data showing the potential benefit of Zometa®, Modified Citrus Pectin and pomegranate juice. The holiday period after induction hormone blockade is a logical time to try non-toxic treatments with the hope of delaying the re-initiation of hormones. These treatments are not universally effective but risks from side effects are low. When response occurs, quality of life is improved. With greater experience, the development of optimal methods for combining these treatments is likely to result in further improvement in response rates

 

SUNDAY

Getting Radiation without Getting Hurt
“Great!”
Dr. Michael Steinberg began by reviewing a bit of the history of prostate radiation and the case for using higher doses of radiation. He expressed caution in interpreting historical retrospective RT studies as the dose was likely too low. He stressed the importance of using the latest targeting techniques for IMRT that allow us to better shape the dose to the prescribed targets, with less dose to surrounding tissues and fewer complications. These include: Portal imaging; Steroscopic x-ray guidance; Ultrasound (i.e. BAT); Volumetric imaging with Cone-beam CT and finally GPS/Calypso (discussed in the August PCRI Insights). Further, he discussed the potential of hypofractionation providing higher dose fractions in fewer treatments. Dr. Kevin Lin discussed the indications for immediate (adjuvant) post-prostatectomy radiation (including positive margin, extra-capsular extension and seminal vesicle involvement) as well as the randomized data supporting those guidelines. Adjuvant radiation can delay metastases and the need for hormonal therapy. Additionally, he discussed the appropriate timing of radiation after prostatectomy for patients experiencing a PSA rise.


2008 Outstanding Presentation (based on attendee evaluations)

Oligometastatic Disease - Can men with metastatic cancer become disease-free?
“Translates the medical info into terms we can understand.” “Great teacher. Brought us a wonderful message of hope.”
Dr. Charles “Snuffy” Myers discussed the importance of treating oligometastic disease, which means few metastases. Newly diagnosed patients often have cancer cells in blood and bone marrow. Only about half of men with PSA-producing cells in their bone marrow develop metastases. Why don’t all men with cancer cells in their bone marrow relapse with metastatic disease? First, in men with high-risk disease at diagnosis, the cancer is still limited to the pelvis in three quarters of men and potentially curable with radiation. Second, men with bone metastases that grow and spread slowly can enter complete remission with systemic treatment plus radiation.

He discussed the characteristics of “Favorable Metastatic Disease” as:

• PSA doubling time slower than 6 months, even better, 9 months
• Five or fewer metastatic lesions (bone and lymph node)
• Long period of time passed without new lesions developing

He stated the “Goals of Therapy” as:

• Prolong period of tumor dormancy with antiangiogenesis agents like Avodart®/Proscar®, Celebrex®, Avastin® & Sutent®; immuno-surveillance agents such as: Leukine® & possible vaccines; and dietary interventions including: vitamin D, pomegranate, Mediterranean diet
• Use radiation plus systemic therapy to eliminate metastatic disease as it appears

The Role of Chemotherapy in Prostate Cancer
“Magnificent presenter. Slides were rather easier to study. Explains slides very well.”
Dr. Richard Lam began with the two landmark Phase III studies (2004) that demonstrated improved survival with Taxotere® (docetaxel) and resulted in the FDA approval as the first-line treatment for metastatic prostate cancer that progresses on Androgen Deprivation Therapy. But Taxotere does not extend survival for all and can have significant (but often manageable) side-effects. Dr. Lam discussed a variety of combinations that address these issues. In one study, adding thalidomide improved PSA response (53% vs 37%) and survival ( 26mo vs 15 mo) but increased risk of blood clot and numbness. Another study added Avastin® to the two and obtained PSA response of 90%. Two studies with Taxotere/Xeloda® reported 68% and 73% of patients had PSA response (defined as >50%). For treatment after Taxotere failure, PSA response has been demonstrated with: Taxol/Carboplatin/Emcyt (40%); Taxotere & custirsen (40%). He also discussed several new and promising agents and new trials using Taxotere for newly diagnosed patients with high-risk prostate cancer in conjunction with prostatectomy, radiation and androgen deprivation.

Tips and suggestions for controlling prostate cancer until we find a cure
“Excellent. A real professional. Thank you for coming.”
Dr. Nicholas Vogelzang discussed the development of hormone resistance—usually signaled by a rising PSA while on ADT. A rising PSA after local treatment/hormone therapy is presumed due to prostate cancer cells somewhere in the skeleton since bone metastases are ultimately found in >90% of patients. PSA has primacy in managing prostate cancer (but has not replaced the bone scan, CT and MRI). He suggested several other markers that can be used to improve on PSA and showed a nomogram for predicting probability of survival. Recent studies suggest that for men with advanced disease, measuring whether the number of cancer cells circulating (CTC) in the blood stream is rising or falling may be a more accurate method for determining response than PSA. CTC’s are found in many cancers but are most common in prostate cancer. A drop in CTC after chemo by 2-5 weeks is a better indicator of prognosis than PSA. Pain can also be used to predict overall survival. Dr. Vogelzang discussed several recent trial failures and some reasons as to why trials fail. He also gave a view into the development pipeline through 2013 and discussed three promising agents: Abiraterone®, MDV3100 and Avastin® (see below)

New Discoveries in Prostate Cancer Research Arena
“Speaker is so enthusiastic he salivates over the subject!”
Dr. Howard Soule spoke of major advances in technology that have propelled the biological understanding of cancer to unprecedented levels. Laboratories all over the world (academic, government and industrial) are working to apply these new findings to discovery of new medications that will fight cancer. Many of these new experimental medications are heralded by the new discipline of predictive medicine: physicians will treat cancer as a single disease and tailor treatments by these molecularly-defined signatures. He provided a review of the progress for two new drugs he mentioned last year. Abiraterone® – has demonstrated in Phase I/II trials to be safe and have anti-tumor activity with a PSA response (>50%): Pre-Taxotere® 38/54 (70%) – Post-Taxotere 16/34. A Phase III trial is now underway for post-Taxotere at 175 sites. MDV3100 – Currently under investigation in a Phase I/II trial in patients with castrate resistant prostate cancer. The proportion showing PSA decline suggests a dose response with 9% of patients having a 90% drop in PSA at 60 mg/day vs 29% at 240. MDV3100 has been well-tolerated and higher doses are being explored. He also described a new Phase III trial of Taxotere with Avastin® (bevacizumab), which is approved for the use in metastatic colon cancer, breast cancer and non-small cell lung cancer. Finally, he discussed the new Phase III trail of pomegranate juice. He closed with a plea for more participants in these prostate cancer trials.

The final session was a Multi-Disciplinary Round Table including many of the conference speakers. It featured several case presentations and selected questions from the audience.

 

 

 

 



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