Controlling the Control Arm in Metastatic Castration-Resistant Prostate Cancer Trials: Best Standard of Care or the Minimum Standard of Care

[cujoe]

"A substantial number of anticancer drugs receive marketing authorization on the basis of data that do not prove their superiority over standard-of-care treatment because of the use of substandard control arms in clinical trials."

Many who read here make their treatment decisions based on good faith that CTs are 100% reliable sources of efficacy data. This series from MedPage Today (a commentary, interview, and linked research) shine a very bright light on why those highly touted CT results might not be as reliable as you (and your MO or other treatment doc) think. It is also a reason to be careful of advice offered on PCa cancer forums by non-medical, self-professed experts who offer unqualified treatment advice to patient questions on those forums - often using results from such trials as the basis for doing so.

The first link is to the MPT article that got my attention and the next are to an interview with one the researchers and with a medical practitioner. The last link is to the full research paper. (The opening sentence of that paragraph is the one reproduced at the start of this post.)

Controlling the Control Arm in Metastatic Castration-Resistant Prostate Cancer Trials: Best Standard of Care or the Minimum Standard of Care? - ASCO > Prostate Cancer - MedPage Today - June 9, 2022

medpagetoday.com/reading-ro...

Simon Van Wambeke, MD, on 'Substandard' Control Arms in Clinical Trials – Practice found common in prostate cancer studies - by Jeff Minerd , Contributing Writer, MedPage Today - June 9, 2022

medpagetoday.com/reading-ro...

Raising the Standard of Substandard Control Arms in MCRPC Trials – Use of control arms beneath the contemporary standard should be prohibited, particularly for pivotal registration trials.

- by Peter E. Lonergan, MD, FRCS June 9, 2022

medpagetoday.com/reading-ro...

Controlling the Control Arm in Metastatic Castration-Resistant Prostate Cancer Trials: Best Standard of Care or the Minimum Standard of Care? - ASCO Jourmal of Clinical Oncology - February 21, 2022

ascopubs.org/doi/full/10.12...

For those who want to look deeper into this topic, I suggest you read the 2 books linked below by Vinayak Prasad and explore the often-controversial work of the Stanford researcher John Ioannidis. I first took note of Ioannidis when I came across his paper titled, "Why Most Published Research Findings Are False". And while the research he is most critical of is not the random, double-blinded, controlled CT that are the "gold standard" for all research, his career critiquing research methodology is only confirmed by this recent paper on PCa trials.

ENDING MEDICAL REV∃RSAL :: Improving Outcomes, Saving Lives

by VINAYAK K. PRASAD, MD, MPH

ADAM S. CIFU, MD

Can be downloaded for eReaders here:

usa1lib.org/book/3365435/ac...

Malignant : how bad policy and bad evidence harm people with cancer by Vinayak K. Prasad

Can be downloaded in PDF format here:

usa1lib.org/book/5472075/ca...

John Ioannidis - Stanford Profile

med.stanford.edu/profiles/j...

Link to his controversial 2005 PLoS Med paper:

Why Most Published Research Findings Are False

ncbi.nlm.nih.gov/pmc/articl...

Our cancers belong to us. They do not come like a virus or bacteria from a one-time contact with some outside source, but from malfunctions within the cellular replications normal to daily life. We own it, pure and simple - and no one will better advocate for our continued good health than we will. Caveat Emptor with all things related to health is not optional - it is required.

Stay informed, advocate at every opportunity, and stay safe & well. Ciao - Captain K9

[NPfisherman]

K9 Terror,

Great information !!!

This is a sad statement on Pca trials... The concept of using an already "failed" drug as Physician Treatment of Choice is crap... How do we advance treatment if we use "less than optimal" as the standard for comparison, or even in this case a treatment with a big F for failure as use for comparison. This is a big screw you for us as patients....Talk about sleight of hand...

This does not mean that olaparib and other PARP inhibitors do not work for BRCA mutations... They do.... but the benefit may not be as much as these trials show.... Companies should do a head to head with the best option, or at least a viable option, and not a F drug choice...

Just got back in our house after 4 days....huge storm.... no power... stayed in lodging for several days... It's good to be home for Lady M and I... Tomorrow, I will address the 1/2 tree down in my front yard... Are you able to take a call yet or still out of cell range??

Travel well, sailor....

At Home and Ever Dangerous...

[cujoe in reply to NPfisherman]

Still out of cell range until the 23rd. Hosts have returned from their 10 days in HI. Wiped out from the travel HI>LAX>CLT>2hr drive here. Good part is I am solo K9 once again!

Storms must have had you in the target sights. Zero power & trees down sounds like the real deal. Sorry to hear it. Seems Dangerous Dave also lives a dangerous life? Did SBRT happen yesterday or is schedule still in the works? As Gilda Radner frequently reported on SNL, "It's always something". (Usually works out best if it is "something else & somewhere else".)

Stay Safe with all things related to fallen trees and your health.

Ciao - K9 Terror x 1

[NPfisherman in reply to cujoe]

K9 Solo,

Glad to hear you survived in the dog eat dog world... I guess the K9 Terror prevails as always... Indeed, I got the SBRT and the Eligard.... now, to let the n=1 trial continue onward... I will be doing a PSA on Monday and then later post SBRT to see if I am undetectable again... Work continues.... I will be doing some chain sawing later... Got the lawn mowed courtesy of the zero turn....

Be safe and have a great weekend....

Fish and Chips