Clinical Trials / request for information

Hello gents, my chemo has already started to show signs of no longer being effective I am pretty sure that by next year I will be looking at clinical trials (as the last house on the block), can anyone share there knowledge, experience, and thoughts on "Clinical Trials" anyone seeing success with them? my Onc doc said when the time comes he would help me find one to try, what should I look out for, and what should I be looking for, with clinical trials.

thank you,

12 Replies

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  • Ideally it would be an unblinded phase 3 trial

  • Do an advanced search at clinicaltrials.gov. Search by your status (e.g. metastatic castration resistant prostate cancer) and location to see if there is anything near you first. They will tell you what the inclusion and exclusion factors are. The more treatments we have tried, the fewer options for trials there seem to be, but sometimes the doctor can appeal to the drug manufacturer for special opportunities to try a promising drug outside a trial. Good luck.

    I'm at about the same point, and just started bipolar androgen therapy yesterday.

  • There's a clinical trials search section at Malecare.org

  • I've been on the Stampede trial for 5 years, the Aberaterone arm. It's randomised so I was given what the computer decided. PSA at start was 600+, Gleason 7, PSA <O.1 at the moment. Unbelievable, I count myself lucky every day.

    New Stampede trial includes Herceptin. Let's see how that goes.

  • Stampede. A new 11th arm, arm K, is for metformin.

    stampedetrial.org/

    Maybe they should call it Centipede, not Stampede.

    Another arm is Celebrex.

    Celebrex: Anti-cancer effect against a backdrop of concern over "long-term use" for cox-2 inhibitors (eg VIOXX but also many others)

    forbes.com/sites/johnlamatt...

  • I think everyone should have a trial strategy, and I dont think anyone should have the strategy: I will wait until I have no other option and then I will look for one. Many trials exclude people in late stage, or may be looking for the particular condition that you may be in right now. While trials do carry a risk, so does everything else, including doing nothing.

    Interventions come in a few families, and you will likely be eligible for only one trial in any family. One radiation, one hormone, one T-cell, one checkpoint. There are some trials that are not in any of these families, because they are so novel. (Like plerixifor.) Listen to conference audios and videos, join patient groups, find out who is up to something.

  • I am in my 3rd clinical trial. You need to find one that supports your medical profile, if possible. If possible, get a genomic analysis of your tumor(s) and have it sent to a Lab, such as Foundation One, there are others, too. Possibly, there may be a trial that may treat how your PCa has mutated over the years. My 1st was not successful for me (phase3). dropped out after 30 days due to uticaria (rash over entire body-head to toe). 2nd one was for 32 months, until the PSA got to over 1.0, and couldn't handle the fatigue side effect any more. 3rd one (phase 1) is in progress, had to drop out for a month due to liver reaction, and have restarted at a lower dose. No trial is without some risks, generally phase 3 is better than phase 1 trials. You get to contribute to the science and you may find something that helps you even for only a year or two. Every Major cancer center has a list of all their on-going trials, along with what the qualifying and dis-qualifying factors are. Wish you the best!

  • Like Martin said you need a strategy--Another mentioned Gene mapping, at FoundationOne.com, look up and call. Great navigators. You can get your genes identified that Mutated. Then the info coming back to you will list all trials in the World working against the Mutations you have. This could then lead to Tapur.org--for the obtaining any drug/biologic/immunologic, anywhere, whether FDA approved or not. Cannot explain it all. You will need to look up and call.

    But for all men you have to have a strategy. As Martin said. Know your pathology and your mutations, plan ahead. I am at a PSA of undetectable--yet I know where every trial is today, and I am updated regularly, that might be appropriate for me, as I know my Gene Mutations, and I am hooked up with a Tapur.org, participating clinic, if needed. And if you live in a Right To Use State==like I do[North Carolina]--get paperwork completed that allows for use of any experimental drug, if times call for its needs. Your State.gov, will be needed for registration, if it is a Right To Use State. All I can suggest---

    Nalakrats

  • One of the most important things to know about clinical trials for new drugs or biologics is that Phase I trials are trials that are conducted for the first time in humans. These trials should be reserved only for patients who have no other options. They typically will test for safety and MTD (maximum tolerated dose). They don't necessarily look for efficacy.

  • thanks for the info, wow I have a lot to consider here.

  • Your oncologist or urologist should be able to find any trials that would fit your eligibility. The Urology group that is treating me has a single point of contact, one doctor who handles all trials. I am on my second trial now with xtandi plus a second mystery drug from Eli Lilly. I don't know if the Eli Lilly drug is doing any thing but the at least the xtandi is. My PSA went from 130 to 5.

  • Nice, I love to hear success, that's pretty good, good luck to you, let's hope for continued success.

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