Another second line androgen blocker, Darolutamide is in phase III clinical trials. It's showing quite a bit of promise so far. It may prove to be more effective than other AR blockers currently being used and tested.
This is certainly one worth keeping an eye on.
Here's a quote from an article:
"One advantage is that darolutamide has been found to block the activity of all tested/well-known mutant ARs in prostate cancer, including the recently identified clinically-relevant F876L mutation that produces resistance to enzalutamide and apalutamide.
Good to know they are working on new and better androgen blockers. I checked the trials 339 locations, unfortunately I would be excluded from this trial, Lets hope it gets fast tracked.
Exclusion Criteria:
•Prior treatment with: LHRH agonist/antagonists; second generation androgen receptor (AR) inhibitors such as enzalutamide, ARN-509, ODM-201; other investigational AR inhibitors; CYP17 enzyme inhibitor such as abiraterone acetate or oral ketoconazole as antineoplastic treatment for prostate cancer, chemotherapy or immunotherapy for prostate cancer prior to randomization.
The strategy often used with a new drug is to test on CRPC cases, because (a) accrual is not a problem, (b) there are fewer ethical considerations & (c) the FDA will fast track anything with even modest benefit in CRPC cases.
But that's a foot in the market ploy. The ultimate target is new ADT cases.
A bit aggressive though, for a trial to combine with Taxotere in new ADT cases, IMO.
Calls itself a "Phase III Study", but "The purpose of the study is to assess the efficacy and safety" of the combo. "Safety"? Isn't that Phase I?
Agree, looks like they are going for the "early use" concept, similar to STAMPEDE and LATITUDE and hoping to achieve a similar result. I also think it's a bit ambitious. Wish they had started with CRPC patients.
It's a new trial, they just started enrolling patients in Nov, 2016. They are expecting 1300 patients and the trial is expected to be completed in 2022. Hoping to be around then, but who knows.
safety is the priority in phase 1 trials but assessing safety is always an objective of every trial.
There's another trial called ARAMIS. The first exclusion on the list is: "History of metastatic disease at any time or presence of detectable metastases."
Another new and improved antiandrogen coming down the pike. These drugs are more specific blocking testosterone from the pc rather than the whole body. Wonder if combining the old ones flutamide etc.with the new sequencing and rechallenging for chronic controll .
It looks like it's an improvement over Xtandi (enzalutamide) when it comes to crossing the blood-brain barrier. I think it's about 1/4 of enzalutamide so the risk of seizures is less. As far as I know, it has not been approved for metastatic castrate resistant prostate cancer.
my husband passed away just 2 weeks before apalutamide was approved. his oncologists had no problem with him being put on apalutamide despite extensive bone mets. organ mets, no...but, bone mets, yes. unfortunately, he died two weeks too soon.
Very sorry to hear. I know you were trying to get Darolutmide a while back. They need to move faster with these drugs, the whole approval process seems so slow.
actually, i tried to get darolutamide under the ''right to try'' rules before it was approved and two researchers independently replied that it was NOT for cases as advanced as his. they said, essentially, that it was only for early stage cancer.
Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them.
Never delay seeking advice or dialling emergency services because of something that you have read on HealthUnlocked.
'Substandard' Control Arms in Clinical Trials– Practice found common in prostate cancer studies
Darolutamide and Desunomab Questions
ARASENS Trial
Reversal of Apalutamide and Darolutamide Aldo-Keto Reductase 1C3-Mediated Resistance by a Small Molecule Inhibitor. 2020 Mar 3
New Drug BAY1841788 (ODM-201) has been successful for CRPC patients, Clinical trial Phase III completed.
