FDA-Approved Prostate Cancer Treatments- MPR

FDA-Approved Prostate Cancer Treatments

FDA-APPROVED PROSTATE CANCER TREATMENTS
Generic	Brand	Strength	Form	Usual Dose
ALKYLATING AGENT
estra– mustine	Emcyt	140mg	caps	14mg/kg in 3 or 4 divided doses
ANTHRACENEDIONE
mitoxan– trone	—	2mg/mL	soln for IV infusion after dilution	12−14mg/m² every 21 days
ANTIANDROGENS
abiraterone acetate	Yonsa	125mg	tabs	mCRPC: 500mg once daily (in combination with methylprednisolone 4mg twice daily). Give concurrent GnRH analog or should have had bilateral orchiectomy. Hepatic impairment (Child-Pugh B): 125mg once daily; discontinue if ALT/AST >5×ULN or total bilirubin >3×ULN and do not re-treat.
abiraterone acetate	Zytiga	250mg, 500mg	tabs	1g once daily on an empty stomach (in combination with oral prednisone 5mg twice daily [mCRPC] or 5mg once daily [mCSPC]). Give concomitant GnRH analog or should have had bilateral orchiectomy.
apalutamide	Erleada	60mg, 240mg	tabs	CRPC, mCSPC: 240mg once daily. Give concurrent GnRH analog or should have had bilateral orchiectomy.
bicalu– tamide	Casodex	50mg	tabs	50mg daily
darolu– tamide	Nubeqa	300mg	tabs	nmCRPC, mHSPC: 600mg twice daily until disease progression or unacceptable toxicity. Give concurrent GnRH analog or patient should have had bilateral orchiectomy. For mHSPC: give the 1st of 6 docetaxel cycles within 6wks after the start of Nubeqa; may continue Nubeqa even if a docetaxel cycle is delayed, interrupted, or discontinued.
enzalu– tamide	Xtandi	40mg	caps	CRPC, mCSPC: 160mg once daily. Give concurrent GnRH analog or should have had bilateral orchiectomy.
enzalu– tamide	Xtandi	40mg, 80mg	tabs
flutamide	—	125mg	caps	250mg every 8hrs
nilutamide	Nilandron	150mg	tabs	300mg once daily for 30days, then 150mg once daily, starting day of or day after surgical castration
ANTIMICROTUBULE AGENTS
docetaxel	Taxotere	20mg/mL	soln for IV infusion after dilution	mCRPC: 75mg/m² once every 3wks with oral prednisone.
cabazitaxel	Jevtana	60mg/ 1.5mL	soln for IV infusion after dilution	mCRPC: 20mg/m² every 3wks, with oral prednisone 10mg/day during treatment; 25mg/m² may be used in select patients.
AUTOLOGOUS CELLULAR IMMUNOTHERAPY
sipuleucel‑T	Provenge	Minimum 50 million autolo– gous CD54+ cells activated with PAP-GM-CSF/ 250mL dose	susp for IV infusion	Autologous use only. Obtain product release from manufacturer, match patient identity on product and Cell Product Disposition form, check expiration date and time on product before infusing. Premedicate 30min before infusion with acetaminophen and antihistamine. Give three doses at 2‑wk intervals. For each dose: Give entire contents of bag by IV infusion over 60min; do not use filter; do not use if clumps do not disperse with gentle mixing. Observe patient for at least 30min after infusion. May interrupt or slow infusion if acute transfusion reaction occurs; do not restart if product at room temp for >3hrs.
ESTROGENS*
conjugated estrogens	Premarin	0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg	tabs	1.25−2.5mg 3 times daily
estradiol	Estrace	0.5mg, 1mg, 2mg	scored tabs	1−2mg 3 times daily
estradiol valerate	Delestrogen	10mg/mL, 20mg/mL, 40mg/mL	soln for IM inj	30mg or more every 1 or 2wks
estrogens, esterified	Menest	0.3mg, 0.625mg, 1.25mg, 2.5mg	tabs	1.25−2.5mg 3 times daily
GnRH ANALOGUES
goserelin acetate	Zoladex	3.6mg	SC implant	Advanced prostate cancer: One 3.6mg implant every 28 days or one 10.8mg implant every 12wks. Stage B2-C prostatic carcinoma (in combination with flutamide): Initially one 3.6mg implant, followed in 28 days by one 10.8mg implant; or may use one 3.6mg implant every 28 days. Treat 8wks prior to and during radiotherapy.
goserelin acetate	Zoladex 3-Month 10.8mg	10.8mg	SC implant
leuprolide acetate	—	1mg/0.2mL	soln for SC inj	1mg SC daily
	Eligard	7.5mg, 22.5mg, 30mg, 45mg	ext-rel susp for SC inj	7.5mg SC once per month; or 22.5mg SC once every 3mos; or 30mg SC once every 4mos; or 45mg SC once every 6mos
	Lupron Depot 7.5mg	7.5mg	depot susp for IM inj	7.5mg IM once a month (4wks); or 22.5mg IM once every 3mos (12wks); or 30mg IM once every 4mos (16wks); or 45mg IM once every 6mos (24wks)
	Lupron Depot–3month 22.5mg	22.5mg
	Lupron Depot–4month 30mg	30mg
	Lupron Depot – 6month 45mg	45mg
leuprolide mesylate	Camcevi	42mg	emulsion for SC inj	Advanced: 42mg once every 6mos
triptorelin pamoate	Trelstar	3.75mg, 11.25mg, 22.5mg	pwd for IM inj after reconsti– tution	3.75mg every 4wks or 11.25mg every 12wks or 22.5mg every 24wks
GnRH ANTAGONISTS
degarelix	Firmagon	80mg/ vial, 120mg/ vial	pwd for SC inj after reconsti– tution	Give by SC inj in abdomen once every 28 days; avoid waist and rib areas. Two 120mg injections once, then one 80mg inj once every 28 days.
relugolix	Orgovyx	120mg	tabs	360mg on day 1, then 120mg once daily. If treatment is interrupted for >7days, restart at 360mg, then 120mg once daily.
Poly (ADP-ribose) Polymerase (PARP) Inhibitors
olaparib	Lynparza	100mg, 150mg	tabs	HRR gene-mutated or BRCAm mCRPC: 300mg twice daily until disease progression or unacceptable toxicity. Give concomitant GnRH analog or should have had bilateral orchiectomy. For BRCAm mCRPC: give abiraterone 1000mg once daily with prednisone or prednisolone 5mg twice daily.
rucaparib	Rubraca	200mg, 250mg, 300mg	tabs	Deleterious BRCA-mutated mCRPC: 600mg twice daily until disease progression or unacceptable toxicity. Give concurrent GnRH analog or patient should have had bilateral orchiectomy.
OTHERS
niraparib/ abiraterone acetate	Akeega	50mg/500mg, 100mg/500mg	tabs	BRCAm mCRPC: 200mg/1000mg once daily (in combination with prednisone 10mg daily) until disease progression or unacceptable toxicity. Give concomitant GnRH analog or should have had bilateral orchiectomy.
lutetium Lu 177 vipivotide tetraxetan	Pluvicto	1000MBq/mL (27mCi/mL)	soln for IV inj or infusion	PSMA-positive mCRPC: 7.4GBq (200mCi) every 6wks for up to 6 doses, or until disease progression, or unacceptable toxicity.
NOTES
KEY: BRCAm = BRCA-mutated; CRPC = castration-resistant prostate cancer; CSPC = castration-sensitive prostate cancer; GnRH = gonadotropin-releasing hormone; HRR = homologous recombination repair; mCRPC = metastatic castration-resistant prostate cancer; mCSPC = metastatic castration-sensitive prostate cancer; mHSPC = metastatic hormone-sensitive prostate cancer; nmCRPC = non-metastatic, castration-resistant prostate cancer; PSMA = prostate-specific membrane antigen *For palliative treatment only. Not an inclusive list of medications and/or doses. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling. (Rev. 12/2023)

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