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Adding Provenge to Xtandi or Zytiga Reduces Risk of Death by 45% in Metastatic Hormone Resistant Prostate Cancer

Data from more than 6,000 Medicare patients showed that adding the immunotherapy Provenge (sipuleucel-T) to a regimen containing the oral agents Zytiga (abiraterone acetate) or Xtandi (enzalutamide) significantly extended the lives of men with metastatic hormone-resistant prostate cancer (mCRPC). The findings were presented in a poster at the recent American Society of Clinical Oncology (ASCO) 2020 Genitourinary Cancers Symposium in San Francisco, California.

Provenge, marketed by Dendreon Pharmaceuticals, is an immunotherapy that uses a patient’s own immune cells to fight prostate cancer. In it, a fraction of white blood cells that have been exposed to a prostate cancer protein are primed to activate the remaining immune cells to fight cancer. Provenge is the only immunotherapy approved in the U.S. (2010) for prostate cancer that is made from a patient’s own immune cells. Since 2010, second-generation androgen receptor inhibitors, like Zytiga and Xtandi, have become the standard care treatment for men with mCRPC. This led researchers at Dendreon to assess the benefits of Provenge when used in combination with these agents. The researchers examined medical and pharmacy claims from 6,853 Medicare mCRPC patients who had not received any prior treatment, which means they had no treatment claims in the prior year.

Results indicated that the use of Provenge significantly extended patients’ lives from 20.7 months to 35.2 months. This 14.5-month increase in overall survival represented a 45% reduction in the risk of death. Notably, the benefits were seen at any point during treatment, with patients receiving Provenge as part of their first-line treatment seeing the same extension in overall survival as those receiving the therapy in later lines. At three years, nearly half (48%) of patients receiving Provenge in any line of treatment were alive, compared to 28% of those receiving only Zytiga or Xtandi without Provenge.

Recent findings from an observational registry study called PROCEED also showed that men with asymptomatic or minimally symptomatic mCRPC derive the same benefits from Provenge as those that had been demonstrated in IMPACT. Men with low prostate specific antigen (PSA) levels at baseline fared particularly well, living nearly four years after receiving Provenge.

This is in line with another study also presented at the ASCO GU Cancers Symposium, demonstrating that Provenge works better in men with early-stage prostate cancer — who likely have lower PSA levels — than in those with mCRPC.

“These real-world data contribute to a growing body of evidence that Provenge continues to deliver on its promise of helping men with advanced prostate cancer live longer,” said Bruce A. Brown, MD, chief medical officer at Dendreon.

Several blogs describing Provenge including my own experience with it have been posted on this website. See the following links from 2017, 2014, and 2011.

A portion of the above was an excerpt from the Feb. 20th Prostate Cancer News Today, by Iqra Mumal. I strongly encourage readers to subscribe to this e mail prostate cancer news service.

Put Your Hope in God

Several years ago, I experienced an annoying side effect which had arisen related to earlier prostate cancer therapy. The side effect had been “cured” by a specific series of treatments but now it had reared its troublesome head again. One recent Sunday, it was especially troublesome. There are potential treatments for this condition but my excellent Johns Hopkins urologist told me that living with the condition is probably better than medically trying to make everything perfectly normal. “Perfection is the enemy of good”, he stated. So I spent the Sunday dejected and asking God why He had allowed this unwelcome side effect to arise again when it had been so well controlled four years earlier. In the course of a disease, when these disappointments happen, my mind and emotions sink into a mild depression and some degree of anger all of which last 2-3 days after which I acknowledge the situation and resolve to carry on my life as normally as I possibly can.

A day or two later, I read a devotional from Our Daily Bread, April 20, 2020. In Psalm 42, we gain a window into the human spirit as it engages in a profound emotional struggle often related to our disease state. The author of the Psalm copes with his personal crisis by first acknowledging his desperate need of God. I saw a clear picture of myself in this Psalm. The writer of Psalm 42 begins by acknowledging that he needs divine help in his condition by writing in verses 1-2 “As the deer pants for streams of water, so my soul pants for you, my God. My soul thirsts for God, for the living God.” Then he outlines his problem. In his predicament, the Psalmist writes “when can I go and meet with God?” It is as if he is asking “where are you God in all of this?” While my condition was not painful, the writer, like myself, was distraught and disappointed, writing in verse 3 “my tears have been my food day and night.”

Then the Psalmist recalls better days when all was under control and he was living a peaceful life. I could relate to the following “These things I remember as I pour out my soul: how I used to go to the house of God (my church) under the protection of the Mighty One with shouts of joy and praise among the festive throng.” Even though I was experiencing my problem on a Sunday, I was definitely not filled with joy and praise. Instead, like the writer in verse 5, I was saying “my soul, why are you downcast? Why so disturbed within me?” Looking back on God’s unfailing goodness to him in the past, the Psalmist challenges himself: “Why, my soul, are you downcast?” But then, he comes up with the solution. Instead. . . “Put your hope in God.”

For me, one day later, the dawn broke, bright and fair. I could express my hope as the Psalmist wrote in verse 5 ” Put your hope in God for I will yet praise him, my Savior and my God.” In our spiritual and medical struggles, our emotions must be acknowledged. It’s healthy to be completely honest before God, and it’s vital to keep our focus on Him in our emotional anguish. The Psalms were written by people like David who were at times overwhelmed with despair and confusion yet they exhibited a faith-filled confidence in God’s great love, His presence and faithfulness. That’s why we so readily identify with the psalms.

When I look into the sky on a clear night, I can see the stars like the Big Dipper, perfectly aligned in a pattern even though they are millions of light years away. But then, I realized that if I were actually closer to those stars, they would not appear to be so clearly aligned in a pattern. Yet from my distant perspective, they looked carefully configured in the heavens. At that moment, I realized that when I am too close to the negative events in my life and see only my dire situation, I don’t see what God sees. In His big picture, everything is in perfect alignment. His ways are beyond our limited ability to understand or visualize. Yet the One who holds all things together in the heavens and on earth is intimately and lovingly involved with every detail of our lives. Therefore, we “hope in God for we will yet praise him, our Savior and our God.”

If you are unsure of your own personal relationship with this God to whom this post refers, see the following.

When Most Needed, An Unexpected Letter

If two ospreys, created by God Himself, guard their nest as jealously as they do, how much more doesn’t God watch us who hold on to Him? Photo: Bjarne Gabrielsen

This post is very personal to me and provided me with encouragement at this time of personal need. While I am currently asymptomatic, for which I am immensely grateful, I know I have metastatic sites of prostate cancer in my body. Upon a recent visit to my oncologist, he calmly but coldly and clinically told me that I have Stage 4 advanced prostate cancer which really scared me. It took about 2 days for the shock to calm down and for my stomach muscles to fully relax.

In 2007, I experienced a biochemical recurrence of prostate cancer which had supposedly been removed surgically in 1995. Subsequent radiation also failed to totally remove all traces of cancer. Fear gripped my life at that point. Meanwhile, I received an unexpected letter from the wife of the pastor of our country church in Maryland which spoke volumes to me in 2007 and then again today in 2020. I’d like to share a portion of it with you my readers and anyone else who could benefit from its contents.

She wrote as follows. “When an angel appears to someone in the Bible, often the first words out of its mouth are ‘do not be afraid.’ It happened that way to Mary and Joseph, the shepherds in the field, and the two Marys at Jesus’ empty tomb as well as to numerous Old Testament characters. If an angel were to appear to me, I would want to hear those same words. Actually, the phrase ‘do not be afraid’ is reiterated over and over in the Bible which contains 365 commands to ‘fear not’. I think that’s because God knows how prone we are to be afraid anytime we meet up with something we don’t understand or cannot control.

The term ‘do not be afraid’ is invariably linked Biblically with a phrase describing one of God’s characteristics; His presence, His power, His past performance or His promise. ‘Do not be afraid for I am…., or for I will.’ Apparantly, the antidote to fear is the knowledge that God is with us, is powerful and promises to help us. Isaiah 41:10 states ‘do not fear for I am with you; do not be dismayed for I am your God. I will strengthen you and help you; I will uphold you with my righteous right hand.'”

My pastor’s wife continues. “When I was a very little girl, my dad used to take me for walks. My hands were still very tiny and his hands were very large. I would hold onto one of his fingers so that I wouldn’t fall. But my dad knew that wasn’t enough, for if I started to tumble I could easily lose my grip on his finger. He used to let me hold his finger but then he would wrap his other big fingers around my little hand so that even if I let go, he would still be holding on to me. He said that was a picture of the way God holds us with His big hand. Yes Lord”, she continued, “hold my hand tightly. I’m holding on to you but even more important I’m glad you’re holding on to me more than ever when I am afraid.”

So now, I am finding that the posts I am writing serve not only to hopefully encourage other men with medical issues like mine, but they serve to provide strength and encouragement for myself as I read them again. If you want to read any of the previous Encouragement posts, simply go to the Godandprostate.net home page and enter the word “Encouragement” in the search area. If you are unsure of your personal relationship with such a God and His Son, Jesus, see the following link.

A Life of Peace

This website usually focuses exclusively on prostate cancer but this particular post could apply to the current worldwide coronavirus pandemic as well.

Right now we as a nation and many of us as individuals may have a potential medical problem that has our stomach in knots with persistent worry. For most of us, it is the COVID-19 virus and its consequences but for many of us men it might also be cancer. We may be so focused on our situation that it feels like we’re carrying a heavy load on our shoulders. The Lord offers a liberating alternative: “Cast your burden upon [Me] and [I] will sustain you” (Psalm 55:22). Though God doesn’t erase all the ills that invade this life, He instead shields us from the weight of worry by taking our situation into His own hands.

However, the call to a peaceful life is impossible without confidence in the Lord. That trust is built through a relationship with Him, praying through trials and triumphs, seeking His guidance, and testing His Word to see that it is true and practical for life.

When we’ve experienced God’s faithfulness and believe He will continue to act on behalf of His followers, that’s when peace is possible. “No eye has seen any God besides you who acts on behalf of those who wait for Him” (Isaiah 64:4). In fact, peace is not only possible but promised to the believer who trusts in Him. Philippians 4:6-7 states “do not be anxious about anything, but in everything, by prayer and petition with thanksgiving, present your requests to God. And the peace of God, which transcends all understanding, will guard your hearts and minds in Christ Jesus.” But unshakeable peace isn’t instantaneous; it is cultivated through a consistent relationship with the Lord.

May we as a nation and as individuals place our trust in the words of Isaiah 26:2-4 which states as follows. “Open the gates that the righteous nation may enter, the nation that keeps faith. You will keep in perfect peace him whose mind is steadfast, because he trusts in You. Trust in the Lord forever, for the Lord, the Lord, is the Rock eternal.”

Much of this post was an excerpt from the February 26th, 2020 devotional from In Touch Ministries by Dr. Charles Stanley.

Molecular Imaging PSMA PET/CT Could Transform Management of People with Aggressive Cancer

Upon recent discussions with my urologist and oncologist, they both informed me that the following is a highly significant development in imaging of prostate cancer.

A medical imaging technique, known as PSMA PET/CT, that provides detailed body scans while detecting levels of a molecule associated with prostate cancer could help doctors better tailor treatments for their patients, by determining the extent of disease spread at the time of diagnosis. This was the finding of a randomized, controlled trial involving 300 patients in Australia recently published in The Lancet journal.

The approach combines two imaging technologies – positron emission tomography (PET) and computed tomography (CT) – and is almost one third more accurate than standard CT and bone scans at pinpointing the spread of prostate cancer throughout the body. PSMA PET/CT proved to be 92% accurate compared with only 65% accuracy with standard imaging. Although the study did not assess whether the scans had any effect on patient survival, the researchers say this approach could improve outcomes by helping doctors decide whether to offer a localized treatment, such as surgery or radiotherapy, or to use more advanced treatments to treat the whole body if the cancer has already spread.

Prostate cancer is commonly treated by surgery to remove the prostate or intensive radiotherapy to target the tumor. If there is a high risk the cancer may have spread to other parts of the body, patients may be offered medical imaging – typically CT and bone scans – to help doctors determine if additional treatments are needed. Study lead Professor Michael Hofman of the Peter MacCallum Cancer Centre, Melbourne, said: “Taken together, our findings indicate that PSMA-PET/CT scans offer greater accuracy than conventional imaging and can better inform treatment decisions. We recommend that clinical guidelines should be updated to include PSMA PET/CT as part of the diagnostic pathway for men with high risk prostate cancer.” Both imaging techniques involve exposure to radiation but the dose associated with PSMA-PET/CT was less than half that associated with conventional imaging (8.4mSv vs 19.2mSv).

Researchers sought to investigate if a molecular imaging approach could help doctors better define the extent of disease at the time of diagnosis. This approach involves giving patients a radioactive substance that detects a molecule called Prostate Specific Membrane Antigen (PSMA), which is found at high levels on prostate cancer cells. They then undergo a PET/CT scan. The CT scan produces detailed images of the body’s organs and structures, while the PET scan lights up areas where PSMA is present at high levels, indicating the presence of prostate cancer cells.

The study involved 300 men recruited to ten sites across Australia. All of the men had been diagnosed with prostate cancer, confirmed by tests on prostate tissue samples, and were deemed to be at high risk of having aggressive disease. The men were randomly assigned to receive either conventional CT and bone scans (152 patients) or PSMA-PET/CT (148 patients). Men then swapped over and were given the scans using the alternative imaging arm unless more than three sites of cancer spread were detected on the initial scans (18 patients). A second round of scans were undertaken at six months if there was any concern about ongoing prostate cancer following treatment. The results of these scans were used to confirm tumor spread, in addition to biopsies and change in blood tests.

Overall, the researchers found the PSMA-PET/CT scans were much more accurate than conventional CT and bone scans at detecting cancer spread (92% vs 65%). This is because the new technique was better at detecting small sites of tumor spread. Conventional imaging failed to detect that the cancer had spread in 29 patients, giving a false negative result. By comparison, PSMA-PET/CT gave false negative results in just six patients. Furthermore, fewer men had false positive results obtained with the new technique (2 with PSMA-PET/CT and 9 with conventional imaging)

PSMA-PET/CT scans had greater impact on the way patients’ disease was managed, with 28% having their treatment plans changed after the scans (41/147) compared with 15% following conventional imaging (23/152). When PSMA-PET/CT was given at the second round of imaging after conventional imaging, disease management plans were still changed in more than a quarter of cases (39/146, 27%). When conventional imaging was used at the second round, however, just 5% of patients had their treatment plans changed (7/135 patients).

Professor Declan Murphy, senior author, of Peter MacCallum Cancer Centre, Melbourne, said “Around one in three prostate cancer patients will experience a disease relapse after surgery or radiotherapy. This is partly because current medical imaging techniques often fail to detect when the cancer has spread, which means some men are not given the additional treatments they need. Our findings suggest PSMA-PET/CT could help identify these men sooner, so they get the most appropriate care.”

For further details, see the following from the Prostate Cancer Foundation, March 22, 2020.

Rubraca Granted FDA Priority Review for Advanced Prostate Cancer in Men with BRCA Mutations

The U.S. Food and Drug Administration (FDA) has granted priority review to Clovis Oncology’s application seeking approval of Rubraca (rucaparib) for treating men with recurrent metastatic castration (hormone)-resistant prostate cancer (mCRPC) and BRCA mutations.

Clovis submitted its application to the FDA in November, 2019. The priority review status will shorten Rubraca’s regulatory review for this indication to six months from the standard 10 months.

Nearly 12% of men with mCRPC have a mutation in the BRCA1 or BRCA2 genes, which are involved in DNA repair. These tumors rely on other DNA repair mechanisms — including those involving PARP enzymes that act as DNA damage sensors — to survive and grow. Thus, treatments that block PARPs’ activity (PARP inhibitors), such as Rubraca, are particularly effective in BRCA-mutated tumors. Rubraca is already approved for the treatment of several gynecologic tumors carrying BRCA mutations, and as a maintenance therapy regardless of BRCA mutations.

Rubraca’s new application was supported by data from the TRITON2 Phase 2 trial (NCT02952534), which is evaluating its safety and effectiveness in up to 360 mCRPC patients with mutations in BRCA genes or in other 13 DNA repair genes known to increase susceptibility to PARP inhibitors.

Besides eligible mutations, participants must have experienced disease progression after at least one but no more than two previous androgen-receptor targeted therapies and one prior taxane-based chemotherapy for their castration-resistant disease.

TRITON2’s main goals were to assess overall response rates in men with measurable disease, and the proportion of men who saw a reduction in the levels of prostate-specific antigen (PSA) — a biomarker of prostate cancer — after treatment. Secondary goals included duration of response, time to disease progression or death, overall survival, and safety measures.

Early positive data from TRITON2 led to Rubraca’s breakthrough therapy designation by the FDA for the treatment for mCRPC patients with BRCA mutations, a status intended to accelerate the therapy’s development and review. As of Feb. 28, 2019, 190 patients (98 with a BRCA mutation) had received Rubraca, with a median follow-up of 13.1 months. Among patients with BRCA mutations, results showed that 43.9% of those with measurable disease responded to treatment, and that 60% of these responses lasted at least 24 weeks. Also, 52% of patients had a confirmed PSA response (deemed as a 50% or greater reduction in PSA levels), which lasted a median of 5.5 months.

Rubraca’s safety profile was consistent with prior reports from TRITON2 and other trials, with the most common adverse events being fatigue (55.3%), nausea (49.5%), anemia (37.9%), decreased appetite (27.9%), transient increase in liver enzymes (24.7%), constipation (24.7%), vomiting (22.1%), and diarrhea (21.1%).

The preceding was an excerpt from Prostate Cancer News Today, Jan. 16th by Dr. Marta Figureiredo.

Responding to Life’s Storms

God provides for all His creatures; photo: BJ Gabrielsen

How do you react in a severe storm or if you receive bad news? Do you tense up with fear or do you recall words such as those in Psalm 107:28-30? “Then they cry out to the Lord in their trouble, and He brings them out of their distresses. He calms the storm, so that its waves are still. Then they are glad because they are quiet; so He guides them to their desired haven.”

Personally, the year 2019 was filled with medical challenges. In addition to my 24-year issue with prostate cancer, physicians speculated that I may have bladder cancer as well. When I received this news, I did indeed tense up with fear and uttered the following to God. “Why this too? Isn’t one type of cancer enough?” I discovered that when one gets bad news, it usually takes 2-3 days before the initial shock subsides and I can then more calmly refocus on God’s presence.

Life’s storms can either stunt or accelerate our spiritual growth. The determining factor is our reaction. Some people humbly cry out to the Lord, while others get angry or frustrated with Him and their circumstances. Still, others ignore God and try to figure things out on their own, seeking solutions in every place except God’s Word.

Turning away from the Lord results in a hardened heart for someone who does not have a personal relationship with Him; for a believer, turning away results in spiritual discipline. God wants us to be surrendered to His will whatever the occurrence, because if we are proud, doubting Him or self-reliant, then we aren’t useful for His glory and purpose for our lives. That is why God brings storms across our path- to teach us to fully rely on Him.

When the Lord allows adversity in your life, do you accept it as something designed for your good? Or do you try to bend God to conform to your own will? As difficult as they may be, storms are meant to produce godly character in us. In my own case, why was the storm of potential bladder cancer to be used for my good? After a period of intense questionning of God and His care for me, I was specifically led to Jesus’ prayer to His Father just prior to His crucifixion as payment for all our sins. In Mark 14:36. Jesus intensely prays, “Abba Father, all things are possible for You. Take this cup away from Me; nevertheless, not what I will but what You will.” After some days of struggle, first I likewise fully acknowledged to God that He has the power to eliminate any traces of cancer from my body. I may not witness many dramatic cancer healings today but God indeed has the power to do so if He desires. All things are possible for Him. Second, as in Jesus’ prayer, I pleaded that He take any vestiges of bladder cancer away from my body. Thirdly, and most importantly, I affirmed that even if cancer were to be found, I would trust His care and His will in my life. After a CT scan and a thorough visual examination of my bladder by my urologist, no cancer was revealed. Instead, I had some fragile blood vessels induced as a side effect of previous radiation therapy. Under God’s direction and ministry to me, I had weathered this storm and learned a valuable lesson to pattern my personal prayer to that of Jesus Himself when the next storm arises.

If you are unsure of a personal relationship with God through faith in Jesus, then this post might seem foreign to you. Coming to know God and His Son Jesus in a personal and unique way is the place to start.

A portion of the above was an excerpt from the January 8th, 2020 In Touch Ministries devotional by Dr. Charles Stanley.

A Clinical Trial for Men With Low – Intermediate Risk Prostate Cancer Considering Radiation Therapy.

The National Cancer Institute (NCI) is sponsoring a clinical trial at many locations comparing two types of radiation therapy, stereotactic body radiation therapy (SBRT) with intensity-modulated radiation therapy (IMRT). The former is administered in less than two weeks while the latter is given in five weeks. The aim of the trial is to compare cure rates and side effects. The following video by Dr. Mark Scholz, Executive Director of the Prostate Cancer Research Institute (PCRI) describes the trial now recruiting patients.

Gleason 6 Prostate Cancer is not Deadly

Tumor samples from a prostate biopsy are graded (Gleason score) which is an indication of a tumor’s aggressiveness. The tumor grade reflects how far the cancer cells deviate from normal healthy cells. Gleason 6 cancer looks almost like normal prostate gland tissue while higher Gleason scores are indicative of more serious cancers. The Prostate Cancer Research Institute (PCRI) recently published an e mail video from Dr. Mark Scholz stating that in a survey of 26,000 men, it was concluded that surgically-proven Gleason 6 prostate cancer does not metastasize. Men diagnosed with grade 6 cancer should be followed by “watching” and not “treating”. In this study, 22 men with positive nodes were regraded to Gleason 7 or higher. If this study is applicable to your case, please be advised to discuss this video and its conclusions with your personal urologist or oncologist.

Message to Men; Please Circulate

Blogger Dr. Bjarne (B.J.) Gabrielsen at Boca Grande Lighthouse, Charlotte Harbor, Punta Gorda, Southwest Florida Gulf Coast

I am a prostate cancer survivor since 1995. If you know of any men in your life who may have an interest in prostate cancer at any stage of disease, please inform them of this website, Godandprostate.net, .com, .org or .info. As blogs are posted, readers can receive them automatically by e mail by simply inserting their e mail address in the indicated space on the right side of the home page. Posts focus on all aspects of prostate cancer as well as encouraging commentaries which we all need at one time or another. Comments on any specific post are always welcome. Remember, as men, we are all in this together and God desires to play a central role in our lives. While I am not a medical doctor, I received my doctorate in organic chemistry at the State University of New York – Stony Brook. My career was evenly distributed between academia (Wagner College, NY and the University of Florida, Gainesville, FL) and government (NCI). I retired from the National Cancer Institute (NCI), National Institutes of Health (NIH) as Senior Advisor in antiviral and antitumor Drug Discovery and Development.