At the risk of throwing yet more "gasoline on the fire" if this discussion topic, I think it is important for those interested to review what we know (and do not know) as of now. This is a most recent review of the topic out of China. (Not the only nor even the best review article. But a good review just the same.) The devil is in the details!
reader.elsevier.com/reader/...
Concluding remarks and future perspectives
"The historical view of androgen as an energy source or driver of
malignant growth of PC has proven contradictory. Numerous
studies have reported the safe results of TRT application in
non-PC and PC populations, indicating that the actual health
benefits of alleviating TD symptoms and improving quality of
life might outweigh the theoretical but unproven risk of PC
progression.
New clinical and experimental data suggest that the
high androgen levels induced by TRT could be protective
against progression or subsequent tumor recurrence in earlystage
PC. In metastatic or locally progressive PC, TRT is more
likely to be discontinued owing to worsening clinical symptoms
or PSA progression, which could be due to increased
levels of AR and AR mutations in PC cells following endocrine
Drug Discovery Today Volume 00, Number 00 March 2021 REVIEWS
DRUDIS-2925; No of Pages 9
Please cite this article in press as: Xie, T. et al. The role of androgen therapy in prostate cancer: from testosterone replacement therapy to bipolar androgen therapy, Drug Discov Today
(2021), doi.org/10.1016/j.drudis.20...
TABLE 4
Summary of the results of completed trials with BAT
Authors No. of
patients
Patient population Treatment regimen Outcomes Refs
Feltquate et al.
(2006)
36 Progressive PC (increasing PSA and
clinical metastases)
Testosterone on days 1 to 7, and
an estrogen patch on days 8 to
21
No imaging and clinical progress,
and PSA decreased continuously
[62]
Szmulewitz
et al. (2009)
15 Early CRPC (with minimal metastatic
disease)
Transdermal testosterone at 25,
50 or 75 mg/day
One patient experienced
symptomatic progression, and 20%
(3/15) demonstrated a decrease in
PSA (the largest was 43%)
[64]
Morris et al. (2009) 12 CRPC (disease burden or symptoms
not designated)
Testosterone via 5 mg
transdermal patch or 1% gel for
1 week, 1 month, or until disease
progression
30% of the patients showed PSA
declines; one patient showed a PSA
decline of >50% from baseline
[65]
Schweizer et al.
(2015)
16 Asymptomatic CRPC with low to
moderate metastatic burden
Testosterone (400 mg
intramuscularly day 1 of 28) and
etoposide (100 mg oral daily;
days 1 to 14 of 28)
50% (7/14) experienced PSA
decline, with 28.6% (4/14) showing
a PSA response of
50%. Of the 10
patients who had evaluable soft
tissue metastases, 50% had
assessable imaging regression
[79]
Schweizer et al.
(2016)
29 HSPC (with low metastatic burden
or biochemically recurrent disease,
who achieved PSA < 4 ng/dl after 6
months of ADT)
Testosterone 400 mg
intramuscularly on days 1, 29,
and 57
59% (17/29) had a PSA level of
< 4 ng/mL at 18 months; 80% (8/10)
objective responses were observed
(four complete; four partial)
[80]
Teply et al. (2018) 30 mCRPC post progression on
enzalutamide
Alternating 3-month cycles of
BAT (400 mg intramuscularly on
days 1, 29 or 57), followed by 3
months of ADT alone
30% achieved PSA response; 29
patients progressed on BAT, 52%
regained PSA response to
enzalutamide treatment
[81]
Reviews POST SCREEN
therapy, resulting in increased sensitivity of cancer cells to
androgens.
It is evident that TRT still needs to be used with caution in
patients with progressive PC. But the indications from the available
studies are that, after rigorous screening, TRT can be applied to
hypogonadism in patients with AS or low-risk PC after radical
treatment.
BAT, which is based on studies of TRT, is an emerging innovative
strategy that has changed our understanding of testosterone
and its interaction with PC. Existing evidence supports BAT as an
appropriate therapy for men with treated PC, particularly those
men with low to moderate metastatic burden or castrationresistant
cancer. However, not all patients exhibit a positive
response to BAT, which is common in all cancer treatments,
although it emphasizes that there is still much research to be
done before BAT can be widely applied."
more possibilities after exhausting SOC?: Enzalutamide-resistant castration-resistant prostate cancer: challenges and solutions
