Switching from Lupron to Orgovyx.

The Lupron shot you've had will take some time after its advertised shelf life to clear your system.

I personally don't see any issue in switching, what does your medical team say?

As to mono-therapy with an ARI, yes, that is a possible option. Supporting data for that comes out of the EMBARK trial so discuss that with your medical team.

I'm off treatment now. When, not if, I go back treatment I intend to have that discussion with my oncologist. It should be interesting as he swears we'll do 24 months ADT + ARI and SBRT (the EMBARK trial has as an arm the 24 month ADT+ARI).

I also will discuss the PATCH trial which uses an trans-dermal estrogen patch vice ADT.

As to being on bone strengthening agents while on ADT, yes and no. My general understanding is one should have a baseline bone density scan. For those on longer term ADT, possibly, short term, less so. There is also resistance training which can be a factor in mitigating the bone density impacts of longer term ADT.

Kevin

Phil

From the trial protocol...http://patch.mrcctu.ucl.ac.uk/media/1310/patch-protocol_v150_may_clean_signed-2024_.pdf

In order to be considered eligible for enrolment in this trial, patients should fulfil one of the
criteria in the first section.

Additionally, all patients must fulfil all of the criteria in the second section and none of the exclusion criteria.

Newly Diagnosed Patients
…with one of:-
(i) Stage T3/4 NO or NX M0 histologically confirmed prostate adenocarcinoma with
either PSA≥20ng/ml or Gleason sum score ≥6
(ii) Stage Tany N+ M0 or Tany Nany M+ histologically confirmed prostate adenocarcinoma
(iii) Multiple sclerotic bone metastases with a PSA≥50ng/ml without histological
confirmation of prostate cancer
OR
Patients with histologically confirmed prostate adenocarcinoma
previously treated with radical surgery and/or radiotherapy who are now relapsing …with at least one of:-
(i) PSA ≥4ng/ml and rising with doubling time less than 6 months
(ii) PSA ≥20ng/ml
(iii) Documented evidence of metastatic disease with PSA>4ng/ml

For all patients
(i) Intention to treat with continuous long-term ADT (> 3 year
(ii) Fit for all protocol treatment and follow-up, WHO performance status 0-2 (see Appendix A)
(iii) Should have completed the appropriate investigations prior to randomisation (see Section 4.4)
(iv) Written informed consent
(v) Willing and expected to comply with protocol
(vi) For newly diagnosed N0M0 patients only – Intention to treat with radical radiotherapy (unless there is a specific contraindication; exemption can be sought in advance of consent after discussion with the PATCH Trial Manager).

Note: Prior hormone therapy for localised disease must have been completed at least 12 months previously and
have been no longer than 12 months in duration. It can have been given as adjuvant or neoadjuvant therapy..

Kevin

The patch trial was completed. I’ve already seen a descriptive report of the results in PCa Commentary volume 195 November 2024. The final report Is supposed to be released at the next UK conference. An estradiol patch is just as successful as ADT in suppressing testosterone, but had some positive results. It did reduce brain fog.

If you have BRCA2 it cannot be used, estrogen can cause breast cancer.

Here are some of the results

At 3 years metastasis-free survival was the same for both agents ~86 to 87%. Overall survival
was similar over 14 years of follow-up.
- The adverse effects profile favored tE2, reducing hot flushes from 89% (Lupron) to 44% (tE2).
At 2 years bone mineral density improved by 7.9% ( tE2) vs. a -3% worsening for Lupron. This
change occurred rapidly over the first year. tE2 provided an improved quality of life.
- Cardiovascular adverse effects (heart failure, angina and myocardial infarction and
thromboembolic strokes) were similar, about 7-10% . However, gynecomastia developed in
85% (tE2) vs. 44% (Lupron). Prophylactic low-dose radiation to breast tissue lessens this
development.
- Dr. Langley concluded: “Transdermal estrogen provides choice about expected side effects
and route of administration allowing personalized treatment plans. Transdermal estradiol
should be a standard-of-care ADT option in M0 disease.”

Richard Wassersug PhD, Who wrote the book Androgen Deprivation Therapy has been on estradiol patches and Now estradiol gel for a couple years. He’s given talks over at Ancan.org On the use of the estradiol patch. Here’s the link to one of the webinars
https://ancan.org/talking-estradiol-e2-for-recurrent-and-advanced-prostate-cancer/

Phil

From the trial protocol...http://patch.mrcctu.ucl.ac.uk/media/1310/patch-protocol_v150_may_clean_signed-2024_.pdf

In order to be considered eligible for enrolment in this trial, patients should fulfil one of the
criteria in the first section.

Additionally, all patients must fulfil all of the criteria in the second section and none of the exclusion criteria.

Newly Diagnosed Patients
…with one of:-
(i) Stage T3/4 NO or NX M0 histologically confirmed prostate adenocarcinoma with
either PSA≥20ng/ml or Gleason sum score ≥6
(ii) Stage Tany N+ M0 or Tany Nany M+ histologically confirmed prostate adenocarcinoma
(iii) Multiple sclerotic bone metastases with a PSA≥50ng/ml without histological
confirmation of prostate cancer
OR
Patients with histologically confirmed prostate adenocarcinoma
previously treated with radical surgery and/or radiotherapy who are now relapsing …with at least one of:-
(i) PSA ≥4ng/ml and rising with doubling time less than 6 months
(ii) PSA ≥20ng/ml
(iii) Documented evidence of metastatic disease with PSA>4ng/ml

For all patients
(i) Intention to treat with continuous long-term ADT (> 3 year
(ii) Fit for all protocol treatment and follow-up, WHO performance status 0-2 (see Appendix A)
(iii) Should have completed the appropriate investigations prior to randomisation (see Section 4.4)
(iv) Written informed consent
(v) Willing and expected to comply with protocol
(vi) For newly diagnosed N0M0 patients only – Intention to treat with radical radiotherapy (unless there is a specific contraindication; exemption can be sought in advance of consent after discussion with the PATCH Trial Manager).

Note: Prior hormone therapy for localised disease must have been completed at least 12 months previously and
have been no longer than 12 months in duration. It can have been given as adjuvant or neoadjuvant therapy..

Kevin

The patch trial was completed. I’ve already seen a descriptive report of the results in PCa Commentary volume 195 November 2024. The final report Is supposed to be released at the next UK conference. An estradiol patch is just as successful as ADT in suppressing testosterone, but had some positive results. It did reduce brain fog.

If you have BRCA2 it cannot be used, estrogen can cause breast cancer.

Here are some of the results

At 3 years metastasis-free survival was the same for both agents ~86 to 87%. Overall survival
was similar over 14 years of follow-up.
- The adverse effects profile favored tE2, reducing hot flushes from 89% (Lupron) to 44% (tE2).
At 2 years bone mineral density improved by 7.9% ( tE2) vs. a -3% worsening for Lupron. This
change occurred rapidly over the first year. tE2 provided an improved quality of life.
- Cardiovascular adverse effects (heart failure, angina and myocardial infarction and
thromboembolic strokes) were similar, about 7-10% . However, gynecomastia developed in
85% (tE2) vs. 44% (Lupron). Prophylactic low-dose radiation to breast tissue lessens this
development.
- Dr. Langley concluded: “Transdermal estrogen provides choice about expected side effects
and route of administration allowing personalized treatment plans. Transdermal estradiol
should be a standard-of-care ADT option in M0 disease.”

Richard Wassersug PhD, Who wrote the book Androgen Deprivation Therapy has been on estradiol patches and Now estradiol gel for a couple years. He’s given talks over at Ancan.org On the use of the estradiol patch. Here’s the link to one of the webinars
https://ancan.org/talking-estradiol-e2-for-recurrent-and-advanced-prostate-cancer/

Great info, jeffmarc; I asked about the PATCH trial because my friend has non alcoholic liver cirrhosis but needs ADT. His drs are concerned that Orgovyx could really damage his liver further.
However, the estradiol in the patch is absorbed initially thru the skin and doesn’t do what is called a “first pass” through the liver, thus sparing the enzyme flares that are so common.
And Kevin, I am sure his RO is gonna also give him “the look” when he mentions it!😳