ExcelMale
Menu
Home
What's new
Latest activity
Forums
New posts
Search forums
What's new
New posts
Latest activity
Videos
Lab Tests
Doctor Finder
Buy Books
About Us
Men’s Health Coaching
Log in
Register
What's new
Search
Search
Search titles only
By:
New posts
Search forums
Menu
Log in
Register
Navigation
Install the app
Install
More options
Contact us
Close Menu
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Prostate Related Issues
Transdermal square-wave testosterone therapy: mCRPC
JavaScript is disabled. For a better experience, please enable JavaScript in your browser before proceeding.
You are using an out of date browser. It may not display this or other websites correctly.
You should upgrade or use an
alternative browser
.
Reply to thread
Message
<blockquote data-quote="madman" data-source="post: 254825" data-attributes="member: 13851"><p><strong>Transdermal square-wave testosterone therapy: A pilot trial in metastatic castration-resistant prostate cancer (2023)</strong></p><p><em>Nellowe Candelario, Andrew Nicklawsky, Laura Graham, Elaine T. Lam, Eryn Callihan, Michael Wacker, Thomas W. Flaig, Elizabeth R Kessler; the University of Colorado Cancer Center Anschutz Medical Campus, Aurora, CO</em></p><p></p><p></p><p><strong>Background</strong></p><p></p><p><em>Metastatic castration-resistant prostate cancer (mCRPC) becomes resistant to antiandrogen therapies due to a variety of adaptive mechanisms. Intramuscular bipolar androgen therapy (BAT) which alternates between high and low testosterone (T) levels is therapeutically active in mCRPC and confers sensitivity to second-generation androgen receptor antagonists such as enzalutamide (ENZA). We hypothesized that transdermal T with sustained supraphysiologic T levels would lead to high response rates to ENZA in mCRPC. We also hypothesized Square-wave transdermal T therapy would be a safe alternative to BAT due to the ability to quickly withdraw therapy in the setting of symptoms.</em></p><p></p><p></p><p><strong>Methods</strong></p><p></p><p><em><strong>This was an open-label, single-site, phase 2 feasibility trial in men with asymptomatic mCRPC who had not previously received ENZA. Transdermal T was administered at a dose of 100 mg/day for a minimum of 12 weeks and until disease progression.</strong> <strong>Therapy was then switched to ENZA 160 mg/day until the next disease progression.</strong> Patients who initially responded to T could receive a second course of transdermal T followed by ENZA, remaining on study until progression on both T and ENZA or for the 12-month study duration, whichever was sooner. ADT was continued throughout.<strong><em> The primary endpoint of the study was feasibility. T dose was adjusted to achieve T levels between 900-1500 ng/dL.</em></strong> Secondary endpoints included PSA50 response rate (50% decline in PSA) and safety. </em></p><p></p><p></p><p><strong>Result</strong></p><p></p><p><em><strong>Fifteen patients were enrolled. Ten (66.7%) had Gleason .8 disease. Thirteen (86.7%) patients had bone metastases. The median baseline PSA was 11.73 ng/mL.</strong> The primary endpoint of feasibility based on patient recruitment and retention was met. <strong>The median testosterone level on T was 901.3 ng/dL (Range: 645.2 to 1171.1). Median time on therapy was 15.9 weeks on T and 25.9 weeks on ENZA. PSA50 was 13.3% on initial T therapy and 66.7% after switching to ENZA.</strong> Three (20%) patients did not initiate ENZA after T progression. Two desired to avoid androgen-related side effects and 1 initiated chemotherapy. <strong>No Grade 3 or higher adverse events (AEs) occurred on T and the most common AEs were weight gain, rash, and nipple sensitivity. </strong></em></p><p></p><p></p><p><strong>Conclusions</strong></p><p><strong></strong></p><p><strong><em><u>Square-wave transdermal T alternating with ENZA is feasible and achieves adequate T levels in the treatment of asymptomatic mCRPC</u>. Given the acceptable safety profile and quick reversibility, transdermal T warrants further exploration, and we have expanded enrollment to include higher-risk patient populations.</em></strong></p></blockquote><p></p>
[QUOTE="madman, post: 254825, member: 13851"] [B]Transdermal square-wave testosterone therapy: A pilot trial in metastatic castration-resistant prostate cancer (2023)[/B] [I]Nellowe Candelario, Andrew Nicklawsky, Laura Graham, Elaine T. Lam, Eryn Callihan, Michael Wacker, Thomas W. Flaig, Elizabeth R Kessler; the University of Colorado Cancer Center Anschutz Medical Campus, Aurora, CO[/I] [B]Background[/B] [I]Metastatic castration-resistant prostate cancer (mCRPC) becomes resistant to antiandrogen therapies due to a variety of adaptive mechanisms. Intramuscular bipolar androgen therapy (BAT) which alternates between high and low testosterone (T) levels is therapeutically active in mCRPC and confers sensitivity to second-generation androgen receptor antagonists such as enzalutamide (ENZA). We hypothesized that transdermal T with sustained supraphysiologic T levels would lead to high response rates to ENZA in mCRPC. We also hypothesized Square-wave transdermal T therapy would be a safe alternative to BAT due to the ability to quickly withdraw therapy in the setting of symptoms.[/I] [B]Methods[/B] [I][B]This was an open-label, single-site, phase 2 feasibility trial in men with asymptomatic mCRPC who had not previously received ENZA. Transdermal T was administered at a dose of 100 mg/day for a minimum of 12 weeks and until disease progression.[/B] [B]Therapy was then switched to ENZA 160 mg/day until the next disease progression.[/B] Patients who initially responded to T could receive a second course of transdermal T followed by ENZA, remaining on study until progression on both T and ENZA or for the 12-month study duration, whichever was sooner. ADT was continued throughout.[B][I] The primary endpoint of the study was feasibility. T dose was adjusted to achieve T levels between 900-1500 ng/dL.[/I][/B] Secondary endpoints included PSA50 response rate (50% decline in PSA) and safety. [/I] [B]Result[/B] [I][B]Fifteen patients were enrolled. Ten (66.7%) had Gleason .8 disease. Thirteen (86.7%) patients had bone metastases. The median baseline PSA was 11.73 ng/mL.[/B] The primary endpoint of feasibility based on patient recruitment and retention was met. [B]The median testosterone level on T was 901.3 ng/dL (Range: 645.2 to 1171.1). Median time on therapy was 15.9 weeks on T and 25.9 weeks on ENZA. PSA50 was 13.3% on initial T therapy and 66.7% after switching to ENZA.[/B] Three (20%) patients did not initiate ENZA after T progression. Two desired to avoid androgen-related side effects and 1 initiated chemotherapy. [B]No Grade 3 or higher adverse events (AEs) occurred on T and the most common AEs were weight gain, rash, and nipple sensitivity. [/B][/I] [B]Conclusions [I][U]Square-wave transdermal T alternating with ENZA is feasible and achieves adequate T levels in the treatment of asymptomatic mCRPC[/U]. Given the acceptable safety profile and quick reversibility, transdermal T warrants further exploration, and we have expanded enrollment to include higher-risk patient populations.[/I][/B] [/QUOTE]
Insert quotes…
Verification
Post reply
Share this page
Facebook
Twitter
Reddit
Pinterest
Tumblr
WhatsApp
Email
Share
Link
Sponsors
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Prostate Related Issues
Transdermal square-wave testosterone therapy: mCRPC
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to our use of cookies.
Accept
Learn more…
Top