Clinical Guide · Earlier-Line PSMA

Early-line Lu-177 PSMA therapy: moving upstream.

Q: What is the difference between mHSPC and mCRPC?

mHSPC (metastatic hormone-sensitive prostate cancer) is metastatic prostate cancer that has not yet become resistant to androgen deprivation therapy — testosterone suppression still controls the cancer. mCRPC (metastatic castration-resistant prostate cancer) is metastatic prostate cancer that continues to progress despite testosterone suppression. Most metastatic prostate cancers transition from mHSPC to mCRPC over time; the transition typically takes 18-36 months. Current FDA approval for Lu-177 PSMA is for taxane-refractory mCRPC [1].

Q: When does Lu-177 PSMA become available for earlier-line use?

Timing depends on regulatory submissions. The PSMAfore trial supports moving Lu-177 PSMA to pre-taxane mCRPC; regulatory submissions to FDA and EMA are ongoing. The PSMAddition trial in mHSPC has its primary readout expected from 2026, with regulatory submission following if positive. Patients in earlier disease states today typically access Lu-177 PSMA through clinical trial enrolment or, in some jurisdictions, evidence-based off-label use under multidisciplinary review [3][4].

Q: Can patients get Lu-177 PSMA before chemotherapy?

Based on current FDA labelling, Lu-177 PSMA-617 (Pluvicto) is approved after both ARPI and taxane chemotherapy. The PSMAfore phase III trial established efficacy in pre-taxane mCRPC patients (median rPFS 12.0 vs 5.6 months on ARPI switch) [2]. At some experienced centres, evidence-based off-label use in pre-taxane mCRPC is considered under multidisciplinary review; this is jurisdiction-dependent and requires patient-specific discussion with the treating team.

Q: Can patients with hormone-sensitive prostate cancer get Lu-177 PSMA?

Currently, the use of Lu-177 PSMA in metastatic hormone-sensitive prostate cancer (mHSPC) is investigational — not approved by FDA or EMA for this indication. The PSMAddition phase III trial is testing this use with primary readout expected from 2026 [4]. Patients with mHSPC interested in Lu-177 PSMA today should discuss trial enrolment options with their treating team.

Q: What is the PSMAfore trial?

PSMAfore (NCT04689828) is a phase III trial that compared Lu-177 PSMA-617 versus an alternate androgen receptor pathway inhibitor (ARPI switch) in 468 mCRPC patients who had progressed on one prior ARPI but had not yet received taxane chemotherapy. The trial reported median radiographic PFS of 12.0 months on Lu-177 PSMA versus 5.6 months on ARPI switch (HR 0.43; p<0.0001), and PSA response ≥50% in 58% versus 20% [2]. PSMAfore established the rPFS benefit of Lu-177 PSMA in pre-taxane mCRPC.

Q: What is the PSMAddition trial?

PSMAddition (NCT04720157) is a phase III trial testing Lu-177 PSMA-617 in metastatic hormone-sensitive prostate cancer (mHSPC), an earlier disease state than the currently approved indication. The trial randomises approximately 1,144 newly diagnosed mHSPC patients to standard of care (ADT + ARPI) ± Lu-177 PSMA-617. Primary endpoint is radiographic PFS. Primary readout is expected from 2026 [4].

Q: What is oligometastatic prostate cancer?

Oligometastatic prostate cancer refers to a limited number of metastatic lesions (typically 1-5) discovered after primary therapy. Oligometastatic disease lies between localised cancer and overt high-volume metastatic disease and may be treated with metastasis-directed therapy (stereotactic radiotherapy or surgery to individual lesions) ± systemic therapy. The Bullseye trial is testing Lu-177 PSMA in this disease state [5].

Q: Are there risks to using Lu-177 PSMA earlier?

The known side effects of Lu-177 PSMA — xerostomia, fatigue, cytopenia, and rarely renal toxicity — exist regardless of disease state. The relative balance of risk versus benefit may differ in earlier disease states: earlier-line patients typically have better organ function reserve and may tolerate the treatment better, but the absolute benefit of adding Lu-177 PSMA to standard care must be weighed against treatment burden. Trials in earlier disease states (PSMAfore, PSMAddition) include detailed safety monitoring [8].

Q: Is Lu-177 PSMA replacing chemotherapy for prostate cancer?

Not currently — Lu-177 PSMA and taxane chemotherapy address different needs in different disease states. Taxane chemotherapy (docetaxel) is established in mHSPC (CHAARTED, STAMPEDE) and as a treatment option in mCRPC. Lu-177 PSMA is currently approved post-taxane and is being tested earlier (PSMAfore, PSMAddition, UpFrontPSMA). The future sequence may use both modalities in coordinated combination or sequence rather than as alternatives [9].

Q: What about combinations with PARP inhibitors or immunotherapy?

Several trials are testing Lu-177 PSMA in combination with PARP inhibitors (LunAR with olaparib in BRCA-altered mCRPC) and immunotherapy. The rationale is that radiation-induced DNA damage may synergise with PARP inhibition (preventing DNA repair) or with checkpoint inhibitors (enhanced antigen presentation). These trials are ongoing; combination Lu-177 PSMA is investigational [10].

Lu-177 PSMA-617 was first approved for end-of-line, taxane-refractory metastatic castration-resistant prostate cancer. The evolving evidence base — PSMAfore, PSMAddition, Bullseye — is reshaping the sequencing of PSMA-targeted therapy. A sourced clinical guide to what moving upstream means and where the evidence currently stands.

Dr. Ishita B. Sen, MDDirector & Chief, Nuclear Medicine · FMRI

Published 14 May 2026

Reviewed by Dr. Dharmender Malik

13 min read

Last reviewed by Dr. Dharmender Malik on 14 May 2026 · this article reflects the published primary literature and current clinical practice at FMRI Gurugram.

Introduction

Lu-177 PSMA-617 (marketed as Pluvicto in the United States and Europe) received FDA approval in March 2022 based on the VISION phase III trial, which enrolled patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed through both an androgen receptor pathway inhibitor (ARPI — abiraterone or enzalutamide) and a taxane-based chemotherapy^[1]. This positioning placed Lu-177 PSMA at the end of the standard treatment sequence. Since 2022, the evolving evidence base has begun to reshape that positioning. Trials testing Lu-177 PSMA in earlier disease states — pre-taxane mCRPC, hormone-sensitive disease, oligometastatic disease — are changing the question of when Lu-177 PSMA should be considered. This article is a sourced clinical guide to the current evidence on moving Lu-177 PSMA upstream.

The current approved indication — taxane-refractory mCRPC

AI Overview · short answer

The current FDA-approved indication for Lu-177 PSMA-617 (Pluvicto) is for adults with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have received prior treatment with both an androgen receptor pathway inhibitor (abiraterone or enzalutamide) and taxane-based chemotherapy (typically docetaxel). The pivotal VISION trial enrolled this patient population and showed median radiographic progression-free survival of 8.7 months on Lu-177 PSMA + standard of care versus 3.4 months on standard of care alone (HR 0.40; p<0.001), and median overall survival of 15.3 versus 11.3 months (HR 0.62; p<0.001)^[1].

The VISION outcomes established Lu-177 PSMA as a meaningful, FDA-approved option for end-of-line mCRPC. The clinical question that follows is: if Lu-177 PSMA works at the end of the treatment sequence, would it work better — or with less toxicity — if used earlier?

PSMAfore — Lu-177 PSMA before taxane chemotherapy

The PSMAfore phase III trial (NCT04689828) tested Lu-177 PSMA-617 versus an alternate androgen receptor pathway inhibitor (ARPI switch — for example abiraterone after enzalutamide progression, or vice versa) in mCRPC patients who had progressed on one prior ARPI but had not yet received taxane chemotherapy^[2]:

Patient population — 468 randomised mCRPC patients, PSMA-positive on Ga-68 PSMA-11 PET-CT, post-progression on one ARPI, taxane-naive (or considered unsuitable for taxane).
Primary endpoint — median radiographic PFS 12.0 months on Lu-177 PSMA-617 versus 5.6 months on ARPI switch (HR 0.43; p<0.0001).
PSA response (≥50% decline) — 58% on Lu-177 PSMA versus 20% on ARPI switch.
Overall survival — interim analyses ongoing; crossover from ARPI switch arm to Lu-177 PSMA after progression complicates the OS comparison.

PSMAfore established the rPFS benefit of Lu-177 PSMA in pre-taxane mCRPC and is the basis for ongoing regulatory submissions to move the formal indication upstream^[3].

PSMAddition — Lu-177 PSMA in hormone-sensitive disease

The PSMAddition trial (NCT04720157) is testing Lu-177 PSMA-617 in an even earlier disease state — metastatic hormone-sensitive prostate cancer (mHSPC), before castration resistance has developed^[4]:

Patient population — Approximately 1,144 newly diagnosed mHSPC patients with PSMA-positive disease on Ga-68 PSMA PET-CT.
Design — Standard of care (androgen deprivation therapy + androgen receptor pathway inhibitor) with or without Lu-177 PSMA-617.
Primary endpoint — radiographic progression-free survival.
Status — Enrolment completed; primary readout expected in 2026 or later^[4].

Investigational status

Lu-177 PSMA-617 in metastatic hormone-sensitive prostate cancer is investigational — not currently approved by FDA, EMA, or other regulators for this earlier indication. Patients considering enrolment in PSMAddition or comparable trials should review the trial protocol, informed consent, and randomisation framework with their treating team.

Bullseye and other earlier-line trials

The Bullseye trial (NCT04443062) is testing Lu-177 PSMA in oligometastatic recurrence of prostate cancer after primary therapy — a disease state that lies between localised cancer and overt metastatic disease^[5]. Other ongoing earlier-line trials include:

UpFrontPSMA (NCT04343885) — Lu-177 PSMA + docetaxel versus docetaxel alone in de novo high-volume mHSPC^[6].
SPLASH (NCT04647526) — Lu-177 PSMA-I&T (variant ligand) versus ARPI in pre-taxane mCRPC^[7].
ECLIPSE (NCT05204927) — Lu-177 PSMA-I&T versus ARPI in pre-taxane mCRPC; published topline radiographic PFS benefit in 2024.
NCT05530941 (LunAR) — combination of Lu-177 PSMA-617 with olaparib (PARP inhibitor) in BRCA-altered mCRPC.

Collectively, these trials test the hypothesis that Lu-177 PSMA may be more effective when used in earlier disease states with lower tumour burden, less prior treatment exposure, and better organ function reserve.

The clinical rationale for moving upstream

Several lines of clinical reasoning support testing Lu-177 PSMA in earlier disease states^[8]:

Less heavily pre-treated disease — earlier disease typically shows better PSMA expression and more uniform receptor distribution, which may translate to better response.
Better organ function reserve — earlier-line patients typically have better marrow reserve and kidney function, allowing more cycles to be delivered safely.
Better functional status — earlier-line patients typically have better ECOG performance status, supporting completion of full courses.
Avoidance of cumulative chemotherapy toxicity — moving Lu-177 PSMA before taxane may spare some patients from chemotherapy-related toxicity altogether or delay it.
Possible synergistic effects in combinations — earlier-line combinations with ARPI, PARP inhibitors, or immunotherapy are being tested.

What the published outcomes mean for sequencing

The current sequencing of systemic therapy for prostate cancer — based on FDA-approved labelling and major guideline recommendations^[9]:

Disease state	Established standard	Lu-177 PSMA evidence base
Localised, low-risk	Active surveillance, surgery, radiotherapy	Not applicable
Localised, high-risk	Radical prostatectomy ± adjuvant RT/ADT; radiotherapy + ADT	Investigational only
Biochemical recurrence	Salvage RT; ADT; PSMA PET-guided MDT	Investigational (Bullseye); not approved
mHSPC	ADT + ARPI ± docetaxel (LATITUDE, STAMPEDE, ARASENS)	Investigational (PSMAddition, UpFrontPSMA); not approved
Pre-taxane mCRPC	ARPI switch or docetaxel	PSMAfore established rPFS benefit; regulatory submissions ongoing
Post-taxane mCRPC	Lu-177 PSMA + standard of care (FDA-approved)	VISION-based approval; established standard

The evolving evidence base will likely shift Lu-177 PSMA progressively into earlier lines of treatment over the coming years. Patients currently being treated should expect their multidisciplinary team to integrate evolving evidence into individualised recommendations^[10].

Practical considerations for patients today

For patients today asking about Lu-177 PSMA in earlier disease states, the practical considerations include^[11]:

Off-label use in pre-taxane mCRPC — At some experienced centres, Lu-177 PSMA may be considered in pre-taxane mCRPC based on PSMAfore evidence, even though current FDA labelling specifies post-taxane use. This is jurisdiction-dependent and should be discussed with the treating team.
Trial enrolment — For patients in earlier disease states (mHSPC, biochemical recurrence, pre-taxane mCRPC), trial enrolment is the standard pathway to Lu-177 PSMA. Trial availability varies by country and centre.
Ga-68 PSMA PET-CT eligibility confirmation — Regardless of disease state, PSMA-positive disease on Ga-68 PSMA-11 or F-18 DCFPyL PET-CT is required for Lu-177 PSMA candidacy.
Multidisciplinary review — The decision to use Lu-177 PSMA in any earlier-line context should involve urology, medical oncology, and nuclear medicine in coordinated review.
Documentation of evidence-based rationale — Off-label or investigational use should be documented with reference to specific trial data, expected benefits, and patient-specific reasoning.

The bottom line

The current FDA-approved indication for Lu-177 PSMA-617 is post-taxane mCRPC based on the VISION trial (median rPFS 8.7 vs 3.4 months; OS 15.3 vs 11.3 months)^[1].
The PSMAfore phase III trial established rPFS benefit in pre-taxane mCRPC (12.0 vs 5.6 months); regulatory submissions to move the formal indication upstream are ongoing^[2].
The PSMAddition phase III trial is testing Lu-177 PSMA in metastatic hormone-sensitive prostate cancer (mHSPC) with primary readout expected from 2026^[4].
Multiple other trials (Bullseye, UpFrontPSMA, SPLASH, ECLIPSE, LunAR) are testing earlier-line and combination uses of Lu-177 PSMA across the prostate cancer disease spectrum^[5].
For patients today asking about earlier-line Lu-177 PSMA, the practical pathways are trial enrolment, multidisciplinary case review of evidence-based off-label use where applicable, and continued monitoring of evolving evidence and regulatory updates.

Important

This article describes evolving evidence in prostate cancer therapy. Treatment decisions in your specific situation depend on your disease state, prior treatment history, imaging findings, organ function, and treatment goals — and must be made in coordinated review by your urology, oncology, and nuclear medicine teams. Trial enrolment options should be discussed with your treating team.

"The question patients now ask me is not whether Lu-177 PSMA works — that is settled by VISION — but when to use it. PSMAfore tells us it works before taxane. PSMAddition is asking whether it works before castration resistance even develops. The honest answer for any individual patient today depends on disease state, prior treatment, and which trial framework or off-label evidence pathway applies. The conversation has moved from 'is this a real option' to 'where in your treatment sequence does this fit best.'"

Dr. Ishita B. Sen, MD · Director & Chief, Nuclear Medicine, FMRI

Earlier-line Lu-177 PSMA evaluation · case review

For patients in earlier prostate cancer disease states (pre-taxane mCRPC, oligometastatic recurrence, mHSPC) considering Lu-177 PSMA therapy, our nuclear medicine team can review your specific disease state, prior treatment history, and current PSMA PET-CT imaging to discuss what evidence and pathways apply to your case.

Discuss earlier-line PSMA · WhatsApp +91 8800 988936

For patients & referring clinicians

Frequently asked questions

Q01 What is the difference between mHSPC and mCRPC?

mHSPC (metastatic hormone-sensitive prostate cancer) is metastatic prostate cancer that has not yet become resistant to androgen deprivation therapy — testosterone suppression still controls the cancer. mCRPC (metastatic castration-resistant prostate cancer) is metastatic prostate cancer that continues to progress despite testosterone suppression. Most metastatic prostate cancers transition from mHSPC to mCRPC over time; the transition typically takes 18-36 months. Current FDA approval for Lu-177 PSMA is for taxane-refractory mCRPC [1].

Q02 When does Lu-177 PSMA become available for earlier-line use?

Timing depends on regulatory submissions. The PSMAfore trial supports moving Lu-177 PSMA to pre-taxane mCRPC; regulatory submissions to FDA and EMA are ongoing. The PSMAddition trial in mHSPC has its primary readout expected from 2026, with regulatory submission following if positive. Patients in earlier disease states today typically access Lu-177 PSMA through clinical trial enrolment or, in some jurisdictions, evidence-based off-label use under multidisciplinary review [3][4].

Q03 Can patients get Lu-177 PSMA before chemotherapy?

Based on current FDA labelling, Lu-177 PSMA-617 (Pluvicto) is approved after both ARPI and taxane chemotherapy. The PSMAfore phase III trial established efficacy in pre-taxane mCRPC patients (median rPFS 12.0 vs 5.6 months on ARPI switch) [2]. At some experienced centres, evidence-based off-label use in pre-taxane mCRPC is considered under multidisciplinary review; this is jurisdiction-dependent and requires patient-specific discussion with the treating team.

Q04 Can patients with hormone-sensitive prostate cancer get Lu-177 PSMA?

Currently, the use of Lu-177 PSMA in metastatic hormone-sensitive prostate cancer (mHSPC) is investigational — not approved by FDA or EMA for this indication. The PSMAddition phase III trial is testing this use with primary readout expected from 2026 [4]. Patients with mHSPC interested in Lu-177 PSMA today should discuss trial enrolment options with their treating team.

Q05 What is the PSMAfore trial?

PSMAfore (NCT04689828) is a phase III trial that compared Lu-177 PSMA-617 versus an alternate androgen receptor pathway inhibitor (ARPI switch) in 468 mCRPC patients who had progressed on one prior ARPI but had not yet received taxane chemotherapy. The trial reported median radiographic PFS of 12.0 months on Lu-177 PSMA versus 5.6 months on ARPI switch (HR 0.43; p<0.0001), and PSA response ≥50% in 58% versus 20% [2]. PSMAfore established the rPFS benefit of Lu-177 PSMA in pre-taxane mCRPC.

Q06 What is the PSMAddition trial?

PSMAddition (NCT04720157) is a phase III trial testing Lu-177 PSMA-617 in metastatic hormone-sensitive prostate cancer (mHSPC), an earlier disease state than the currently approved indication. The trial randomises approximately 1,144 newly diagnosed mHSPC patients to standard of care (ADT + ARPI) ± Lu-177 PSMA-617. Primary endpoint is radiographic PFS. Primary readout is expected from 2026 [4].

Q07 What is oligometastatic prostate cancer?

Oligometastatic prostate cancer refers to a limited number of metastatic lesions (typically 1-5) discovered after primary therapy. Oligometastatic disease lies between localised cancer and overt high-volume metastatic disease and may be treated with metastasis-directed therapy (stereotactic radiotherapy or surgery to individual lesions) ± systemic therapy. The Bullseye trial is testing Lu-177 PSMA in this disease state [5].

Q08 Are there risks to using Lu-177 PSMA earlier?

The known side effects of Lu-177 PSMA — xerostomia, fatigue, cytopenia, and rarely renal toxicity — exist regardless of disease state. The relative balance of risk versus benefit may differ in earlier disease states: earlier-line patients typically have better organ function reserve and may tolerate the treatment better, but the absolute benefit of adding Lu-177 PSMA to standard care must be weighed against treatment burden. Trials in earlier disease states (PSMAfore, PSMAddition) include detailed safety monitoring [8].

Q09 Is Lu-177 PSMA replacing chemotherapy for prostate cancer?

Not currently — Lu-177 PSMA and taxane chemotherapy address different needs in different disease states. Taxane chemotherapy (docetaxel) is established in mHSPC (CHAARTED, STAMPEDE) and as a treatment option in mCRPC. Lu-177 PSMA is currently approved post-taxane and is being tested earlier (PSMAfore, PSMAddition, UpFrontPSMA). The future sequence may use both modalities in coordinated combination or sequence rather than as alternatives [9].

Q10 What about combinations with PARP inhibitors or immunotherapy?

Several trials are testing Lu-177 PSMA in combination with PARP inhibitors (LunAR with olaparib in BRCA-altered mCRPC) and immunotherapy. The rationale is that radiation-induced DNA damage may synergise with PARP inhibition (preventing DNA repair) or with checkpoint inhibitors (enhanced antigen presentation). These trials are ongoing; combination Lu-177 PSMA is investigational [10].

Q11 What about Lu-177 PSMA in biochemical recurrence?

Biochemical recurrence (PSA rising after primary therapy without overt metastatic disease) is a disease state where PSMA PET imaging has revolutionised detection of micrometastases. Whether Lu-177 PSMA therapy benefits this earlier disease state is an open question. Some trials (Bullseye) are testing this use. Outside trials, standard care for biochemical recurrence remains salvage radiotherapy, ADT, and PSMA PET-guided metastasis-directed therapy where applicable [5].

Q12 Where can I learn more about earlier-line Lu-177 PSMA?

For Lu-177 PSMA evaluation at FMRI Gurugram — including discussion of where current evidence supports your specific disease state and what trial options may be available — our nuclear medicine team can review your prior treatment record, recent imaging, and current PSA trajectory. WhatsApp +91 8800 988936 to begin a confidential case review.

Citations & references

All clinical numbers above are sourced from the primary literature listed below. Every reference links to the open journal page or the FDA archive — open in a new tab to verify.

[1] Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer (VISION trial). N Engl J Med. 2021;385(12):1091-1103. View source ↗

[2] Sartor O, Castellano D, Herrmann K, et al. Phase 3 trial of Lu-177-PSMA-617 in taxane-naive patients with mCRPC (PSMAfore). Ann Oncol. 2023;34(suppl 2):S1324. View source ↗

[3] Morris MJ, Castellano D, Herrmann K, et al. Lu-177 PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive mCRPC (PSMAfore): phase 3 randomised trial. Lancet. 2024. View source ↗

[4] Novartis. PSMAddition Phase III trial of ¹⁷⁷Lu-PSMA-617 in metastatic hormone-sensitive prostate cancer (NCT04720157). ClinicalTrials.gov. View source ↗

[5] University Medical Center Utrecht. Bullseye: Lutetium-177-PSMA in oligometastatic prostate cancer (NCT04443062). ClinicalTrials.gov. View source ↗

[6] Peter MacCallum Cancer Centre. UpFrontPSMA: ¹⁷⁷Lu-PSMA + docetaxel in mHSPC (NCT04343885). ClinicalTrials.gov. View source ↗

[7] Curium Pharma. SPLASH: ¹⁷⁷Lu-PSMA-I&T versus ARPI in pre-taxane mCRPC (NCT04647526). ClinicalTrials.gov. View source ↗

[8] Hofman MS, Iravani A, Nzenza T, et al. Targeted radionuclide therapy for prostate cancer: A clinical perspective. Eur Urol. 2022;82(2):149-158. View source ↗

[9] National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Prostate Cancer (Version 4.2024). View source ↗

[10] European Association of Urology. EAU Guidelines on Prostate Cancer. 2024 Update. View source ↗

[11] Iravani A, Violet J, Azad A, et al. Lutetium-177 PSMA therapy: practical aspects, dosimetry, and outcomes. Theranostics. 2020;10(20):8854-8866. View source ↗

[12] Hofman MS, Emmett L, Sandhu S, et al. [¹⁷⁷Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP trial). Lancet. 2021;397(10276):797-804. View source ↗

[13] Hofman MS, Violet J, Hicks RJ, et al. [¹⁷⁷Lu]-PSMA-617 in mCRPC (LuPSMA trial). Lancet Oncol. 2018;19(6):825-833. View source ↗

[14] Sweeney CJ, Chen YH, Carducci M, et al. Chemohormonal therapy in metastatic hormone-sensitive prostate cancer (CHAARTED). N Engl J Med. 2015;373(8):737-746. View source ↗

[15] James ND, Sydes MR, Clarke NW, et al. Addition of docetaxel and/or zoledronic acid to standard of care for hormone-naive prostate cancer (STAMPEDE). Lancet. 2016;387(10024):1163-1177. View source ↗

[16] Fizazi K, Tran N, Fein L, et al. Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer (LATITUDE). N Engl J Med. 2017;377(4):352-360. View source ↗

[17] Davis ID, Martin AJ, Stockler MR, et al. Enzalutamide with standard first-line therapy in metastatic prostate cancer (ENZAMET). N Engl J Med. 2019;381(2):121-131. View source ↗

[18] Smith MR, Hussain M, Saad F, et al. Darolutamide and survival in metastatic, hormone-sensitive prostate cancer (ARASENS). N Engl J Med. 2022;386(12):1132-1142. View source ↗

[19] Phillips R, Shi WY, Deek M, et al. Outcomes of observation vs stereotactic ablative radiation for oligometastatic prostate cancer (ORIOLE). JAMA Oncol. 2020;6(5):650-659. View source ↗

[20] Ost P, Reynders D, Decaestecker K, et al. Surveillance or metastasis-directed therapy for oligometastatic prostate cancer recurrence (STOMP). J Clin Oncol. 2018;36(5):446-453. View source ↗

[21] Hennrich U, Eder M. ¹⁷⁷Lu-PSMA-617 (Pluvicto): The First FDA-Approved Radiotherapeutical for Treatment of Prostate Cancer. Pharmaceuticals (Basel). 2022;15(10):1292. View source ↗

[22] Kratochwil C, Bruchertseifer F, Rathke H, et al. Targeted alpha-therapy of mCRPC with ²²⁵Ac-PSMA-617. J Nucl Med. 2017;58(10):1624-1631. View source ↗

[23] Calais J, Czernin J, Cao M, et al. ⁶⁸Ga-PSMA-11 PET/CT mapping of prostate cancer biochemical recurrence after radical prostatectomy. J Nucl Med. 2018;59(4):576-585. View source ↗

[24] Hofman MS, Lawrentschuk N, Francis RJ, et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA). Lancet. 2020;395(10231):1208-1216. View source ↗

[25] Kuo PH, Benson T, Messmann R, et al. Why we did what we did: PSMA PET/CT selection criteria for the VISION trial. J Nucl Med. 2022;63(6):816-818. View source ↗

[26] Sartor O, Sharma D. Cabazitaxel vs ¹⁷⁷Lu-PSMA-617 — TheraP and beyond. Nat Rev Urol. 2021;18(7):385-386. View source ↗

[27] Yadav MP, Ballal S, Tripathi M, et al. ¹⁷⁷Lu-DKFZ-PSMA-617 therapy in mCRPC. Eur J Nucl Med Mol Imaging. 2017;44(1):81-91. View source ↗

[28] Yadav MP, Ballal S, Sahoo RK, et al. ²²⁵Ac-PSMA-617 in mCRPC after Lu-177 PSMA-617 failure. Eur J Nucl Med Mol Imaging. 2024. View source ↗

[29] Sathekge M, Bruchertseifer F, Knoesen O, et al. ²²⁵Ac-PSMA-617 in chemotherapy-naive prostate cancer. Eur J Nucl Med Mol Imaging. 2019;46(1):129-138. View source ↗

[30] Mihatsch PW, Roll W, Schäfers M. Prostate-specific membrane antigen-targeted radioligand therapy in advanced prostate cancer. Future Oncol. 2023;19(11):775-787. View source ↗

[31] Calais J, Gafita A, Eiber MR, et al. PSMA PET imaging and theranostics in prostate cancer. Cancer J. 2024;30(1):24-30. View source ↗

[32] Hofman MS, Buteau JP, Sandhu S, et al. Final overall survival in the TheraP trial: Lu-177 PSMA-617 versus cabazitaxel in mCRPC. Lancet Oncol. 2024;25(1):99-107. View source ↗

About the Author

Dr. Ishita B. Sen

MBBS · MD (Nuclear Medicine) · DNB · Post-doctoral Fellowship, Memorial Sloan Kettering Cancer Center, New York

Director and Chief of Nuclear Medicine at Fortis Memorial Research Institute. Co-founder of Theranostic Physicians Private Limited (TPPL). Two decades of clinical practice in PSMA imaging and PSMA-directed radioligand therapy, with one of the largest Indian institutional experiences in Lu-PSMA.

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