Clinical Trials

Prostate Cancer Support Group - Richmond, Va

Meeting Dates - 3rd Thurs. each month - Time 7:00 PM - No July Meeting - The Dec. date will vary - Call for details - Peter C. Moon Phd. at 804-387-2151 between 7 - 11:00 PM - Location - Ridge Baptist Church, 1515 Eastridge Road Richmond, VA 23229

Rva Prostate Cancer Support Group

www.rvaprostatecancersupport.org

RVA

Clinical Trials Page

In good faith, this website was created to furnish you with helpful information. Nevertheless, no one who contributes or posts information to this website makes any guarantee regarding the information provided. Any decisions that you make regarding your health should be made in consultation with a qualified healthcare provider.

Affiliated with Us-TOO International Prostate Cancer Education & Support Network

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Clinical Trials

Prostate Cancer
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Novel Immunotherapy Agent Safe, Shows Promise Against High-Risk Prostate Cancers

Us Too Warriors,

A new drug, a monoclonal antibody known as enoblituzumab, is safe in men with aggressive prostate cancer and may induce clinical activity against cancer throughout the body, according to a phase 2 study led by investigators at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Institute for Cancer Immunotherapy. If confirmed in additional studies, enoblituzumab could become the first promising antibody-based immunotherapy agent against prostate cancer.

Best
Peter

Link 1 : "Johns Hopkins Kimmel Cancer Center"
or Go To
https://www.hopkinsmedicine.org/kimmel_cancer_center/

Link 2 : "Bloomberg/Kimmel Institute for Cancer Immunotherapy"
or Go To
https://www.hopkinsmedicine.org/dev/xtest_shaun/bki-demo/bki-index.html
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Us Too Warriors,
Mid-Atlantic Clinical trials using CAR-T for castration resistant PCa

Us Too Warriors,
if you have advanced disease this may be of interest. Clinical Trials - See below
Best
Peter

To See the Blog - Click on the Link Below:

Link 1 : "Clinical Trials"
or Go To
http://rvaprostatecancersupport.org/PDF/5 28 22 PSCA.pdf

Us Too Warriors,
List of PCa Clinical trials going on At U. of California Website

Check out this website.
Prostate Cancer clinical trials at University of California Health

Best
Peter

To Go to the Website - Click on the Link Below:

Link : "U. of California"
or Go To
https://clinicaltrials.ucbraid.org/prostate-cancer

Us Too Warriors,
Clinical trials for LU 177 PMSA for hormone sensitive PCa- most in the USA

Check out this website if you have advanced PCa.

Now that the VISION trial of Lu-177-PSMA-617 is no longer recruiting, some patients are wondering if they can still get PSMA-targeted radiopharmaceuticals in the US, without traveling to Germany, Australia, India, etc. Here is a list of trials that are active, still open to recruitment, or will soon be recruiting.
Best
Peter

To Go to the Website - Click on the Link Below:

Link : "Clinical Trial"
or Go To
https://www.prostatecancer.news/2020/08/psma-targeted-radiopharmaceutical.html
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Us Too Warriors,
Too New radiation SBRT regime- 5 doses of 9 Grey Versus 1 Dose of 24 Grey Clinical trial results -both ways are Good for intermediate PCa

This Treatment looks promising for men with intermediate PCa (Gleason 3+4) and they will be doing future Clinical trials for men with locally advanced PCa (Gleason+4 +3). This treatment is new so I am seeing if it has any Chance of developing locally in the future.
See below
Best
Peter

To Read the Paper - Click on the Links Below:

Link 1 : "New"
or Go To
http://rvaprostatecancersupport.org/PDF/3 15 21 Greco-2021-Safety-and-efficacy-of-virtual-pros.pdf

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Us Too Warriors,
Rosemary

A Clinical Trial website for Rosemary extract and curcumin that is being planned is: https://clinicaltrials.gov/ct2/show/NCT04403568.

Below is a paper that discusses the action of Rosemary extract on Many cancers including PCa.

Swanson sells a Rosemary extract pill which I will be using - I also have a Rosemary clump in my Garden which I snip off and add to my stir frys.
Best
Peter

To Read The Paper - Click on the Link Below:

Link : "Rosemary"
or Go To
http://rvaprostatecancersupport.org/PDF/3 4 21 nutrients-08-00731.pdf

To go to the Wewbsite - Click on the Link Below:

Link : "Clinical Trial"
or Go To
https://clinicaltrials.gov/ct2/show/NCT04403568
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Us Too Warriors,
[177Lu]Lu-PSMA-617 vs Cabazitaxel in Patients With Metastatic Castration-Resistant Prostate Cancer

TAKE-HOME MESSAGE

In this phase II trial, 177Lu-PSMA therapy was associated with improved PSA responses compared with cabazitaxel (66% vs 37%) among patients with metastatic castration-resistant prostate cancer and PSMA-positive disease.

These data suggest that 117Lu-PSMA is active and well-tolerated compared with chemotherapy in this patient population.
– Neil Majithia, MD

The patients included in the trial had to have failed a previous abiraterone- or enzalutamide-type novel hormonal agent, and progressive disease at the time of trial entry was required.

Best
Peter

To Read The Paper - Click on the Link Below:

Link : "Lu-PSMA-617 vs Cabazitaxel"
or Go To
https://www.practiceupdate.com/journalscan/78557/67/11?elsca1=emc_enews_weekinreview&elsca2=email&elsca3=practiceupdate_advancedprostatecancer&elsca4=advancedprostatecancer&elsca5=newsletter&rid=NTU2MjE4MTA4NzMS1&lid=20849592
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Us Too Warriors,

Blocking P300-CBP binding in PCa cell nucleus limits PCa growth by down playing the Androgen Receptor

A clinical study is testing a new drug to Block P300-CBP binding with the website shown below below. But about 10 years ago, I went to a cancer seminar at VCU's Massey cancer center by a PHD from Jefferson Cancer Hospital in Philadelphia whose research showed that Curcumin supplements do the same thing - that is one of the reasons I take such a big dose of 15 pills per day.

Best
Peter

More Info - Click on the Links Below:

Link: "Clinical Trial"
or Go To
https://clinicaltrials.gov/ct2/show/NCT03568656
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Us Too Warriors,

Arvinas Releases Updated Dose Escalation Data from Clinical Trial of PROTAC® Protein Degrader ARV-110 in Patients with Metastatic Castration-Resistant Prostate Cancer

See the link below for more information.

Best
Peter

Abstract:

NEW HAVEN, Conn., May 29, 2020 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced updated data from the dose escalation portion of the company’s Phase 1/2 clinical trial of ARV-110 in men with metastatic castration-resistant prostate cancer (mCRPC), to be shared as an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting on May 29, 2020. ARV-110 is a potent, selective, orally available androgen receptor (AR) degrader, and the ASCO presentation highlights promising clinical activity, including both efficacy and AR degradation, in a heavily pretreated patient population.

“For ARV-110 to show signs of efficacy in these patients at this early stage of development is strong validation of our PROTAC® technology,” said John Houston, Ph.D., President and Chief Executive Officer at Arvinas. “In addition, seeing AR degradation demonstrates that ARV-110 is acting on-mechanism to achieve this result, and we are excited to continue clinical development in the hope of bringing a new therapeutic option to patients with significant unmet need.”

More Info - Click on the Links Below:

Link: "Clinical Trial"
or Go To
https://ir.arvinas.com/news-releases/news-release-details/arvinas-releases-updated-dose-escalation-data-clinical-trial/
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Us Too Warriors,

FDA Puts RV001 on Fast Track for Treating Prostate Cancer

FDA fast tracks a vaccine treatment to block Metastasis. See below and attachment of Paper reporting results of clinic trial.

The U.S. Food and Drug Administration (FDA) has granted fast track status to RV001, RhoVac's investigational therapy for prostate cancer, the company announced. Fast track designation helps speed the approval of potential medicines that address unmet medical needs in serious or life-threatening conditions. It grants RhoVac greater access to FDA input throughout the regulatory process and makes RV001 eligible for accelerated approval and priority review, if it meets certain criteria. With the fast track designation, RhoVac also may apply for a "rolling review," in which the company submits sections of its biologic license application for review as they are completed, rather than all together after clinical testing finishes. "We are extremely pleased and proud that our drug candidate, RV001, has earned fast track designation by the FDA," Anders Månsson, RhoVac's CEO, said in a press release. "The fact that the FDA has reviewed our data, and found our drug candidate worthy of this level of priority ... sends a clear signal of recognition of the drug's potential to all our would-be partners, which is something of great importance to us," Månsson said. RV001 is a peptide-based medicine meant to prevent cancer recurrence and spread. The treatment mimics the Ras homolog gene family member C (RhoC), a protein that helps cancer cells migrate and take hold in other tissues, and stimulates the immune system to recognize and target cells producing this protein. While these treatments historically have shown poor effectiveness against solid tumors, the goal of RV001 is to target the metastatic cancer cells, rather than the solid primary tumor. In this manner, the treatment is expected to eliminate spreading cells before they establish hard-to-treat tumors outside the prostate.
Best
Peter

More Info - Click on the Links Below:

Link: "RV001"
or Go To
https://prostatecancernewstoday.com/2020/12/08/fda-puts-rv001-on-fast-track-for-treating-prostate-cancer/
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Link: "Trial Info"
or Go To
https://www.clinicaltrials.gov/ct2/show/record/NCT04114825?term=RV001&cond=Prostate+cancer&cntry=US&draw=2&rank=1

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Us Too Warriors,

Another Clinic Trial to consider.

Clinical trial for Xtandi and Niclosamide in Ca website for CRPC

See below for information

Best
Peter

Click on the Link Below:

Link: "Xtandi"
or Go To
https://www.cureitt.com/trialdetails?nctid=NCT03123978

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Us Too Warriors,

Another Clinic Trial to consider.

Hold Lifted on Phase 1 Trial Testing P-PSMA-101 CAR T-cell Therapy in mCRPC

See below for information

Best
Peter

Click on the Link Below:

Link: "Clinic Trial"
or Go To
https://prostatecancernewstoday.com/

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Us Too Warriors,

A Randomized Clinical Trial Will Assess Efficacy and Safety of Bicalutamide in Hospitalized Patients With COVID-19

The website below describes the clinical trial to see if Casodex will reduce the symptoms of the Virus within three days of diagnosis by lowering TMPRSS2 proteins. I take casodex which has put my cancer in remission as I have the TMPRSS2-ERG fusion mutation.

See below

Best Peter

To Read More:

Click on the Link:

Link: "Clinic trial"
or Go To
https://www.cancertherapyadvisor.com/home/cancer-topics/general-oncology/bicalutamide-covid19-coronavirus-randomized-clinical-trial-efficacy-treatment/?utm_source=newsletter&utm_medium=email&utm_campaign=cta-update-hay-20200727&cpn=&hmSubId=dAxH82apgD81&hmEmail=fr7G03yN6cnk8ADvkszHEA2&NID=1578536835&email_hash=64cf9fac99d02b310899d9548da8fec7&dl=0&mpweb=1323-100174-809173

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Us Too Warriors,

Dr. Bilusic (he spoke at one of our meetings) of NIH - Casodex and Metformin Clinic trial

This is the main treatment that put my cancer in remission. I also take doxycycline and avodart/+proscar along with many antioxidants and anti- inflammatories. This treatment works particularly well for men who have the TMPRSS2-ERG fusion mutation which may occur 50% or more PCa men.

My brothers have the same germline mutation I do. Chris Maxwell in our group took part in the NIH clinical study and had a lowering of his PSA but the study as a whole was not as successful as the selection was restricted and recruiting was difficult. I have been able to make indirect contact with Dr. Kinloch Nelson of Va Urology for Chris to continue the treatment which I hope he will. I think if they had tried it on men with TMPRSS2-erg fusion mutation it would have been very successful. I have also read a paper showing Xtandi is very successful in slowing cancer with mutation growth. Xtandi worked very well for my oldest brother for four years until the fatigue became too much so his PSA is going up now. I am trying to get him to try Casodex Etc which I think will have fewer side effects. The TMPRSS2-ERG mutation is very active in regard to testosterone so at low PSA it reacts well to Avodart and Proscar that keep my cancer growing slowly for 15 years until my PSA grew above 1.0 so by the time it got to 12.2 at 3 years later I had a bone met in my hip and 6+ in my lymph nodes.

Know 2.5 years later my PSA=0.028 and at this level i can not image mets so I am in remission as far as I can tell and my general practitioner is helping me to maintain this treatment as my VCU oncologist retired and and his replacement can not think outside the box of Standard of care Treatment.

If after reading the attachment if you have BCR cancer recurrence and you would like to consider this treatment, especially if you know you have TMPRSS2-ERG Mutation, email me and I will try to contact Dr Nelson in your Behalf to see if it can help you. You do not have to have cancer that fits the parameters of the NIH clinical trial.
Best Peter

To Read More:

Click on the Link:

Link: "Clinic trial"
or Go To
https://www.prostatepedia.net/blogs/prostatepedia/join-a-clinical-trial-casodex-bicalutamide-metformin

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On March 21, 2019 Dr. Marijo Bilusic Program Director,NIH Hematology/Oncology Fellowship,Gave our group a presentation on the work the NIH and the NCI perform. Topics covered were Clinical Trials, Who gets chosen, How the process works and the benefits and opportunities that are available for our group and anyone with cancer. Dr. Marijo Bilusic talked about Clinical Trials & how to find and apply to them. Below are links to the (NIH) National Institute Of Health's "Clinical Research Trials and You" page and (NCI) National Cancer Institute page. The NCI is a part of NIH.

Dr. Marijo Bilusic gave us permission to post this Information (see Below) on our website and invited us to call if we needed help on getting information on how to get into a trial.

Click on Our Links for more information

NIH

or go to:

https://www.nih.gov/health-information/nih-clinical-research-trials-you
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NCI

or go to:

https://www.cancer.gov
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NIH - NATIONAL CANCER INSTITUTE
Marijo Bilusic, M.D., Ph.D.
Program Director, NIH Hematology/Oncology Fellowship
10 Center Dr.------------------------(NCI) 1-800-4-CANCER (1-800-422-6237)
BIdg. 10, Rm. B2L312------------(fax) 240.541.4548
Bethesda, MD 20892--------------marijo.bilusic@nih.gov
U.S. Department of Health & Human Services -- National Institutes of Health

New Hot Topic: Axumin™ (Fluciclovine F 18) Injection for PET Imaging of Recurrent Prostate Cancer - Phillip Koo

Blue Earth Diagnostics’ Initial Results from FALCON Trial Show 61% of Patients with Suspected Recurrent Prostate Cancer had Treatment Plan Changed Following Fluciclovine (18F) PET/CT Scan

Click on Our Link for more information

F 18

or go to:

https://www.urotoday.com/video-lectures/5-for-5-hot-topics-e-david-crawford/video/mediaitem/623-embedded-media2016-06-14-21-42-52.html

Sponsored by National Cancer Institute (NCI)

Prostvac (PSA-TRICOM) in Preventing Disease Progression in Patients With Localized Prostate Cancer Undergoing Active Surveillance

This randomized phase II trial studies how well rilimogene-galvacirepvec works in preventing cancer from worsening,
growing, or spreading (progressing) in patients with prostate cancer that is found only in the prostate and has not
yet spread to other places in the body who are undergoing active surveillance. Vaccines made from a gene-modified virus
may help the body build an effective immune response to kill tumor cells and prevent prostate cancer from progressing.

Click on Our Link for more information

PSA-TRICOM

or go to:

https://clinicaltrials.gov/show/NCT02326805

ClinicalTrials.gov

Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Breast Cancer, Non-small
Cell Lung Cancer, or Prostate Cancer.

Purpose
This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy in treating
patients with breast cancer, non-small cell lung cancer, or prostate cancer that has spread to other parts of the
body. Stereotactic body radiation therapy delivers fewer, tightly-focused, high doses of radiation therapy to all
known sites of cancer in the body while minimizing radiation exposure of surrounding normal tissue.

Click on Our Link for more information

ClinicalTrials

or go to:

https://clinicaltrials.gov/ct2/show/NCT02206334?recr=Open&cond=%22Prostatic+Neoplasms%22&state1=NA%3AUS%3AIL&locn=Loyola&rank=2
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