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ERLEADA® (apalutamide)
Medical Information
ERLEADA - Use of ERLEADA in High-Risk Localized or Locally Advanced Prostate Cancer
Last Updated: 05/07/2026
SUMMARY
Two ongoing phase 3 trials PROTEUS (NCT03767244; N~2000)1 , 2 and ATLAS (NCT02531516; N=1503)3 - 5 and are evaluating the efficacy and safety of ERLEADA in patients with high‑risk localized or locally advanced prostate cancer, with metastasis‑free survival (MFS) as a key primary endpoint in both studies. No safety or efficacy results have been published. - Please refer to ERLEADA - PROTEUS Study and ERLEADA - ATLAS Study for additional information.
- Phase 2 studies have evaluated the safety and efficacy of ERLEADA administered as neoadjuvant or perioperative therapy in patients with highrisk or very highrisk localized or locally advanced prostate cancer, alone or in combination with androgen deprivation therapy (ADT) and other androgen signaling inhibitors.6
-40 These studies have reported oncologic outcomes including minimal residual disease (MRD) rates,6,9 ,10 ,15 ,16 ,18 ,19 pathologic complete response,9-16,18,19,31 tumor volume reduction,6-8 ,30 ,33 ,39 prostate-specific antigen (PSA) responses,11 -14 biochemical recurrencefree survival (RFS),6-8,17 ,20 -27 ,30,32 ,33,39 biochemical progressionfree survival (PFS),18,19 quality of life (QoL),39 and safety outcomes.9-18,20-22 ,32,40 - Results from a phase 2 study that included patients with multiple clinical states of prostate cancer have been published; however, the outcomes were not reported separately for those with high-risk localized or locally advanced prostate cancer.34
,35 Additionally, a phase 2 study reported results related to tumor pathology measures.36
CLINICAL DATA
For additional study information, such as inclusion/exclusion criteria and study endpoints, please click the NCT hyperlinks to access https://clinicaltrials.gov.
Phase 3 Studies
PROTEUS (NCT03767244) is an ongoing phase 3, randomized, double-blind, placebocontrolled, multicenter study evaluating the efficacy (primary endpoints: pathologic complete response [pCR] and MFS) and safety of ERLEADA plus ADT compared to placebo plus ADT before and after radical prostatectomy (RP) in patients with localized or locally advanced high-risk prostate cancer (N~2000). Results have not been published.1,2
ATLAS (NCT02531516) is an ongoing phase 3, randomized, double-blind, placebocontrolled, multicenter study evaluating the efficacy (primary endpoint: MFS) and safety of adding ERLEADA to gonadotropin-releasing hormone agonist (GnRHa) and external beam radiation therapy (EBRT) in patients with high-risk localized or locally advanced prostate cancer (N=1503). Results have not been published.3-5
Study Design/Methods
- Phase 2, randomized, double-blind, placebo-controlled, single-center study
- Patients were randomized 1:1 to receive either neoadjuvant degarelix (240-80-80 mg) plus ERLEADA (240 mg/day; n=45) or neoadjuvant degarelix (240-80-80 mg) plus placebo (n=44) for 3 months followed by RP plus extended pelvic lymph node dissection (ePLND).
Results
Efficacy
- The MRD rate in patients who received degarelix plus ERLEADA vs degarelix plus placebo was 38% vs 9% (relative risk [RR], 4.16; 95% CI, 1.52-11.4; P=0.002).30
- At the final follow-up, there was no statistically significant difference in BCR-free survival between patients with and without MRD (both 62%; HR, 0.97; 95% CI, 0.44-2.13; P=0.93).
- MRD was not significantly associated with MFS (HR, 0.42; 95% CI, 0.10-1.71; P=0.22).
- The median pre-RP PSA nadir in the degarelix plus ERLEADA vs degarelix plus placebo arm was 0.11 ng/mL vs 1.20 ng/mL (HL∆, 1.06 ng/mL; 95% CI, 0.74-1.59 ng/mL; P<0.001).6
- The rate of patients reporting a pre-RP PSA nadir <0.3 ng/mL was 87% in the degarelix plus ERLEADA arm, compared with 9.1% of patients in the degarelix plus placebo arm (RR, 9.53; 95% CI, 3.72-24.4; P<0.001).
- At 6 months following surgery, 93% of patients in the degarelix plus ERLEADA arm and 96% of patients in the degarelix plus placebo arm were free from biochemical recurrence (BCR).
- Additional results were reported for secondary and exploratory endpoints.8,30
Safety
- No grade 4-5 treatment-related adverse events (TRAEs) were reported.
- Grade 3 rash was reported in 4 (8.9%) patients in the degarelix plus ERLEADA arm.
- One serious TRAE (drug-induced interstitial lung disease) was reported in the degarelix plus ERLEADA arm during neoadjuvant treatment.
Study Design/Methods
- Phase 2, investigator-initiated, randomized study
- Patients were randomized 1:1 to receive either single-dose neoadjuvant ADT 10.8 mg subcutaneously (SC) on day 1 plus abiraterone acetate 1000 mg/day plus prednisone 5 mg twice daily (AAP arm; n=31) or AAP with ERLEADA 240 mg/day (A-AAP arm; n=31) for 3 months in 28-day cycles prior to RP.10
Results
Efficacy
- There was no statistically significant difference in pCR/MRD or residual cancer burden (RCB) ≤0.25 cm3 rate between the study arms.
RCB ≤0.25 cm3 rate in patients with a prostate-specific membrane antigen positron emission tomography (PSMA-PET) complete response (psmaCR) and without psmaCR was 50% and 7.5%, respectively (P=0.001). - The rate of biochemical relapse (BR) in patients with RCB ≤0.25 cm3 and >0.25 cm3 was 14% and 38%, respectively (P=0.118).
- At a median follow-up of 2.6 years, all patients with both psmaCR and RCB ≤0.25 cm3 (n=11 [18%]) were free of BR.
- There were 2 grade 5 adverse events (AEs) in the AAP arm (pulmonary embolism [PE] and sudden death, both after surgery).
- Grade 3-4 TRAEs were reported in 9 (14.5%) patients (A-AAP, n=6; AAP, n=3), and the most common grade 3-4 AEs were hypertension (11.3%), aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) elevations (3.2%), and skin rash (1.6%).
- An additional study examined the perioperative complication rates after RP in this HRLPC patient population which received neoadjuvant therapy (neoadjuvant arm, n=61) in comparison with patients with HRLPC without prior neoadjuvant therapy (control arm, n=63).37
- Clavien-Dindo grade ≥3 major surgical complications were reported in 4 (6.6%) patients in the neoadjuvant arm and 5 (7.9%) patients in the control arm at ≤30 days of surgery.
- A total of 64% of patients in the neoadjuvant arm and 22% of patients in the control arm received thromboprophylaxis for 28 days.
- The study reported 2 (4.9%) cases of thromboembolic events in the neoadjuvant arm within ≤30 days after surgery.
- There were 2 deaths reported in each arm, of which, 1 death in the neoadjuvant arm was from possible PE.
- After the first thromboembolic event was identified in the study, a protocol amendment was made to mandate prophylactic anticoagulation therapy after surgery to all patients, except in cases of major contraindication.
Study Design/Methods
- Phase 2, open-label, single-arm study
- Patients received ERLEADA 240 mg orally (PO) daily for 12 weeks followed by RP within 6 weeks of the last dose of medication.
Results
Efficacy
- At a median follow-up of 36.7 months (interquartile range [IQR], 31.140.0 months), 25 patients underwent RP per protocol and were included in the efficacy and safety analysis.
- No patient experienced a pCR.
- Post-prostatectomy nadir PSA levels were achieved in 84% of patients, and the remainder of patients achieved nadir PSA levels of 0.03-0.05 ng/mL.11
- A total of 4 patients did not achieve PSA <0.3 ng/mL. Of the remaining 21 patients that achieved PSA<0.3 ng/mL, 3 patients experienced a BR.
- After treatment with neoadjuvant ERLEADA alone, the median reduction of serum PSA was 97.3% (range, 61.2-100.0; P<0.0001).11
Patient-Reported Health-Related Quality of Life (HRQoL)
- There were no clinically significant changes observed in the overall health scores across 12 weeks of neoadjuvant ERLEADA treatment (n=29; change in mean score, -3.5; P=0.33).
- Reduced cognitive function (P=0.038), role functioning (P=0.025), sexual function (P<0.001) and increased fatigue (P=0.012) were observed.14
Safety
- TRAEs were reported in 93.3% (n=28) of patients; the most common AEs were dry skin (n=16; 53.3%), fatigue (n=10; 33.3%), and skin rash (n=9; 30.0%).
- One patient experienced an unrelated grade 3 AE.11
- Clavien-Dindo grade 1-2 surgical complications were experienced by 5 (20%) patients who underwent RP, and no patients experienced a Clavien-Dindo grade ≥3 surgical complication.13
- Phase 2, open-label, single site study
- Patients received 12 weeks of neoadjuvant therapy with 3 times daily indomethacin 50 mg combined with ERLEADA, abiraterone acetate, and degarelix at their respective Food and Drug Administration (FDA)-approved doses plus prednisone 5 mg twice daily followed by RP.
Results
- One (5%) patient had a pCR, which was identical to the null hypothesized value.
- Six (30%) patients had MRD, for an overall pathologic response rate of 35%.
- Four of these patients had ypT3 disease at the time of surgery.
- Eighteen (90%) patients had ypT3 stage at RP and 7 (35%) had lymph node metastases.
- Eight patients had adjuvant radiation following RP.
- Over a median follow-up for PSA relapse of 23.8 months (IQR, 20.3-26.9 months), 1 of 7 (14%) men with pathologic response and 6 of 13 (46%) men without pathologic response had a PSA relapse (P=0.3).
- Over a median follow-up for metastasis of 24.8 months (IQR, 21.4-32.6 months), 1 of 7 (14%) patients with a pathologic response and 1 of 13 (8%) patients without a pathologic response developed metastasis (P=0.7), both of whom also had PSA relapses.
Safety
- Treatment was well tolerated with AEs consistent with each drug’s safety profile.
Study Design/Methods
- Phase 2, open-label, single-arm, multi-institutional study
- Patients received 6-month treatment with ERLEADA (4×60 mg tablets per day) in combination with:
- Abiraterone (4×250 mg tablets per day) and prednisone (5 mg twice daily)
- Leuprolide (2×22.5 mg 3-monthly intramuscular (IM) injections) with UHRT 7.5 or 8 Gy × 5 fractions
- Primary endpoint: proportion of patients who had a BCR within 36 months after the completion of systemic therapy as defined by the Phoenix criteria (an increase in PSA above post-treatment nadir by ≥2 ng/mL).
Results
Efficacy
- Phoenix-defined BCR was reported in 12 of 63 (19.0%) patients within 36 months after treatment, all of whom had testosterone normalization at the time of BCR.
- The median follow-up duration for 51 evaluable patients without Phoenix-defined BCR was 41 months (range, 34-43).
- Among the intention-to-treat (ITT) population, the Phoenix-defined biochemical RFS rate at 36 months was 84.2% (95% CI, 75.6-93.7).
- Among the 63 evaluable patients, 37 (58%) patients experienced PSA recurrence >0.2 ng/mL using the surgical definition of BCR (any post-treatment PSA ≥0.2 ng/mL).
- Among the ITT population, the surgically defined 3-year biochemical RFS was 42% (95% CI, 31.5-56.1).
- Four patients developed distant metastasis during follow-up, and the 3-year MFS was 93.6% (95% CI, 87.8-99.8).
- Among the 51 evaluable patients without Phoenix-defined BCR, 50 (98%) had normalized testosterone (>150 ng/dL) at last follow-up; the median PSA at that time was 0.10 ng/mL (IQR <0.05-0.20), and 36 patients (71%) had PSA <0.2 ng/mL.
- Among the 58 patients who achieved an undetectable PSA of <0.05 ng/mL during treatment, 8 had Phoenix-defined biochemical failures (BCFs) within 36 months of post-treatment follow-up.
- The 3-year biochemical RFS was 87.7% (95% CI, 79.5-96.7).
- Undetectable PSA was not achieved in 4 of 6 patients (P=0.0025).
Safety
- No acute (≤3 months of treatment completion) grade 4 TRAEs were observed. Grade 3 TRAEs included hypertension, (n=12), rash (n=3), hyperglycemia (n=1), and diarrhea (n=1).
- No grade 3/4 late (>3 months of treatment completion) TRAEs were reported. Grade 2 TRAEs (reproductive system and breast disorders) were reported in 1 (1.6%) patient.
- Statistically significant changes in the Expanded Prostate Cancer Index Composite (EPIC) hormonal and sexual domains were observed at 12 months vs baseline (n=60), and in the EPIC sexual domain at 24 months vs baseline (n=46). No statistically significant changes were observed in the bowel and urinary domains from baseline to 12 months.
Study Design/Methods
- Phase 2, randomized, open-label, multicenter study
- Part 1: patients were randomized (1:1) to receive either ERLEADA 240 mg PO once daily (QD) in combination with abiraterone acetate 1000 mg PO QD plus prednisone 5 mg PO twice daily and leuprolide 22.5 mg every 12 weeks (Q12W) IM; A-APL arm) or abiraterone acetate 1000 mg PO QD plus prednisone 5 mg PO QD and leuprolide 22.5 mg IM Q12W (APL arm) for 24 weeks followed by RP.
- Part 2: the effect of an additional year of adjuvant therapy on 3-year biochemical PFS was evaluated. Patients were randomized (1:1) to receive either ERLEADA 240 mg PO QD in combination with abiraterone acetate 1000 mg PO QD plus prednisone 5 mg PO twice daily and leuprolide 22.5 mg Q12W IM for 12 months (arm 2A) or observation (arm 2B), stratified by neoadjuvant therapy and pathologic T stage.
Results
- Overall, 114 patients had pathologic assessment at RP; 69% of patients enrolled in part 1 were randomized to part 2 of the study.
- The centrally assessed pCR or MRD rate was similar between the treatment arms (1-sided 95% CI, 11%-14%; 1-sided P=0.4).
- All patients with positive surgical margins had ypT3 disease (n=11/61 [18%]), and
no patient with a positive margin or ypT3 disease had MRD. - Most patients had significant residual tumor with ypT3 disease (A-APL, 49%; APL, 58%).
- The rates of lymph node involvement were numerically lower in the A-APL (7.3%) vs APL (17%) arm.
- No patient with lymph node involvement had pCR/MRD.
- Pathologic responders at RP (pCR or MRD) vs nonresponders more likely had baseline <T3 stage (75% vs 29%), lower percent of positive biopsies (median 42% vs 73%), and lower maximum percent tumor involvement in biopsy (median 75% vs 90%).
- The median pre-RP PSA nadir was <0.01 ng/mL in the A-APL arm and 0.02 ng/mL in the APL arm, with the time to nadir of 4.2 months and 4.6 months, respectively.
- In part 2 of the study, the median follow-up was 50.2 months (range, 7.1-63.3) post-RP. In the intent-to-treat analysis, the 3-year biochemical PFS rate was 73% (90% CI, 57-84).
- The 3‐year biochemical PFS rate was 83% versus 69%, respectively, for patients in the A-APL vs observation arm (HR, 0.50; 90% CI, 0.26-0.97).
- Compared to nonresponders, patients who achieved pCR/MRD had improved 3-year biochemical PFS in the A-APL arm (79% vs 100%) as well as in the observation arm (63% vs 100%). However, compared to patients with <ypT3 disease, those with ≥ypT3 disease had worse 3-year biochemical PFS in the A-APL arm (94% vs 75%) as well as in the observation arm (89% vs 53%).
- Of 36 patients in the A-APL arm, 80.6% had testosterone recovery and the median time to recovery from therapy end was 8.7 months (95% CI, 6.3-9.9). In the observation arm (n=42), 95.2% of patients had testosterone recovery and the median time to recovery from RP was 4.0 months (95% CI, 3.8-4.1).
Safety
- TRAEs were comparable in both arms, except for any-grade and grade 3 maculopapular rash, which was more common in the A-APL arm compared with the APL arm.
- A total of 13 (11%) patients experienced grade 3 TRAEs (A-APL, n=8; APL, n=5).
- The most common grade 3 TRAE in the A-APL arm was hypertension (n=5) and in the APL arm was elevated ALT and AST (n=2, each).
- No grade 4 or 5 AEs were reported.
- Three patients discontinued treatment prior to RP due to toxicity in the A-APL arm. No AEs led to treatment discontinuation in the APL arm.
- In part 2 of the study, no new safety signals were observed.
Study Design/Methods
- Phase 2, open-label, single-arm, multicenter study
- Patients received ERLEADA 240 mg PO QD plus injectable ADT within 90 days post-RP for 12 cycles (28 days per cycle).
Results
- With a median follow-up duration of 21.4 (range, 0-32.7) months, the confirmed BCRfree rate at 24 months (12 months after completion of planned treatment) was 100% (90% CI, 93-100) in the modified ITT population (mITT; defined as enrolled patients who met all eligibility criteria, received ≥1 dose of ERLEADA, had a baseline PSA, and had ≥1 PSA value after initiating treatment).
- The BCR-free rate at 12 months (at the end of planned treatment) was 100% (90% CI, 95-100).
- The unconfirmed BCR-free rate at 24 months was 98% (90% CI, 92-100). Two patients had elevated PSA levels (PSA=0.39 ng/mL at 24 months [n=1] and PSA=0.22 ng/mL at 30 months [n=1]) just prior to the end of the study but confirmatory PSA measurements could not be obtained.
- Serum testosterone recovery rates to ≥150 ng/dL in a subset of patients from the mITT population (n=103) following treatment completion were 36% (95% CI, 26-46) and 77% (95% CI, 6685) at 6 and 12 months after treatment, respectively. Serum testosterone recovery rates to ≥50 ng/dL at 6 and 12 months post-treatment were 63% (95% CI, 52-72) and 96% (95% CI, 88-98), respectively.
Safety
- Treatment-emergent adverse events (TEAEs) were reported in 107 patients (99%); of these, 20 (19%) were grade 3 and 4 (3.7%) were grade 4.
- Serious AEs were reported in 16 patients (15%).
- Most commonly reported AEs (³15% of patients) included hot flush (69%), fatigue (54%), rash (21%), COVID-19 (18%), and arthralgia (17%).
Use of a pre-specified rash management guide outlining proactive steps for medical management of rash and patient education on gentle skin care was implemented for patients enrolled in the study, with the intent to reduce the onset and severity of rash events. Rash-related safety data were collected during the first 12 months following initiation of ERLEADA treatment and compared descriptively with the North American patient populations of the global SPARTAN and TITAN studies.22 - Any-grade and grade 3 rash were reported in 21.3% and 13.0% of patients in the APA-RP study, 28.3% and 22.5% of patients in the SPARTAN study, and 33.3% and 33.3% of patients in the TITAN study, with 95.7%, 93.8%, and 57.1% experiencing resolution of rash, respectively. Treatment reductions, interruptions, and discontinuations were reported in 4.3%, 21.7%, and 0% of patients in the APA-RP study, 10.0%, 23.8%, and 6.3% of patients in the SPARTAN study, and 19.0%, 33.3%, and 9.5% of patients in the TITAN study, respectively.
Study Design/Methods
- Prospective, phase 2, multicenter, randomized, 3-arm study
- Patients with high-risk prostate cancer (defined as GS ≥8 or PSA >20 ng/mL) were randomized 1:1:1 to receive either:
- Arm 1: ERLEADA PO QD for 3 months followed by RP (n=20).
- Arm 2: GnRHa SC on day 1, ERLEADA PO QD for 4 times plus abiraterone acetate PO QD for 4 times along with prednisone PO QD for 3 months, followed by RP (n=20).
- Arm 3: immediate RP was performed (n=22).
Results
- Patients were similar in biopsy GS, biopsy T stage, baseline American Urological Association (AUA) symptom scores, QoL scores, and Sexual Health Inventory for Men (SHIM) scores.
- Surgical outcomes: final pathologic GS, surgical tumor, nodes, metastasis (TNM) staging, nodal yield, nodal positivity, blood loss, and complication rate were similar across the 3 groups.
- Functional outcomes: no significant difference between groups in terms of change in AUA symptom scores, SHIM scores, or QoL. Continence at 3 months was significantly better in Arm 1 vs Arm 3 (P=0.009) and continence at 12 months was similar among all 3 groups.
- There was no difference in BCR rates at 12 months.
Study Design/Methods
- Phase 2, open-label, randomized, multicenter, multiarm study
- Patients with newly diagnosed, histologically confirmed clinically localized high-risk prostate cancer were randomized 1:1 to receive ADT in combination with ERLEADA (group 1) or ADT with ERLEADA plus abiraterone acetate (group 2), accomplished by dynamic allocation and stratified by cohort (cohort A or cohort B). Cohort A received either:
- ADT + ERLEADA 240 mg PO QD + AAP (1000 mg PO QD/5 mg PO QD) for 10 months followed by RP and ePLND at 6 months
- ADT + ERLEADA 240 mg PO QD for 10 months followed by RP and ePLND at 6 months
Results
Efficacy
- Overall, 3 (19%) and 1 (6%) patients had radiographic evidence of regional nodal (N1) involvement in the ERLEADA and ERLEADA plus AAP arms, respectively.
- pCR and/or MRD was achieved in 12% (4 of 33) of the patients (90% CI, 4-26).
- Median time to testosterone recovery was 4.9 months (95% CI, 3.3-5.2).
- At 24 months, 8 (50%) vs 12 (71%) patients had an undetectable PSA with testosterone recovery with ERLEADA plus ADT vs
ERLEADA plus ADT plus AAP. - During the off-treatment follow-up period, 6 (18%) of the 33 patients, of whom 3 at 18 months in the ERLEADA arm and 3 at 24 months in the ERLEADA plus ADT plus AAP arm.
- Three (9%) patients in cohort A did not complete treatment and came off study prior to RP because of withdrawal by participant (n=1), an AE (n=1), and a protocol deviation (n=1).
- Three (9%) patients in the ERLEADA arm were continued on ADT beyond the 10-month period per investigator discretion.
Safety
- Grade 4 AEs occurred in 2 of 33 (intra-abdominal hemorrhage and small intestinal obstruction [n=1, 3% each]) vs 1 of 33 (hypertension [n=1, 3%]) patients in the ERLEADA plus ADT vs ERLEADA plus ADT plus AAP arm.
- Grade 3 AEs occurred in 9 of 33 (abdominal infection, urinary tract infection, decreased lymphocyte count, dyspnea [n=1, 3% each], maculopapular rash [n=2, 6%] and hypertension [n=3, 9%]) vs 10 of 33 (increased ALT, hyperglycemia, groin pain, maculopapular rash [n=1, 3% each], pelvic infection [n=2, 6%] and hypertension [n=4, 12%]) patients.
- No new safety signals were observed.
Dubinský et al (2025)40 reported preliminary safety results from a phase 2 study in patients with high-risk localized or locally advanced prostate cancer treated with ERLEADA plus ADT and radiobiologically dose-escalated ultra-hypofractionated prostate and pelvic stereotactic body radiation therapy (SBRT; N=20; 2021-006674-22).38
Study Design/Methods
- Phase 2, interventional clinical study
- Patients received treatment for 18 months with ERLEADA 240 mg QD in combination with:
- ADT
- SBRT to the pelvic nodes (25 Gy), involved nodes (35 Gy), and prostate (36.25 Gy) x 5 fractions on alternate days during month 3
- The study enrollment goal is 43 patients.
- Patients were assigned to either localized or locally advanced high-risk category.
- For more information on the inclusion/exclusion criteria and the study endpoints, please refer to the following link.
Results
Efficacy
- Efficacy results were not reported.
Safety
- All patients were irradiated as planned and remained on ADT and ERLEADA, except 1 patient who underwent dose reduction of ERLEADA to 180 mg.
- Grades 1 and 2 acute gastrointestinal toxicity was observed in 50% and 25% of patients, respectively.
- Grades 1 and 2 acute genitourinary toxicity was observed in 40% and 20% of patients, respectively.
- No grade 3 toxicity was observed.
- AEs of special interest included grade 3 fall in 1 patient; grade 2 and 3 hypertension in 1 patient; grade 2 transitory ischemic attack in 1 patient; grade 1 and 2 skin rash in 2 and 1 patients, respectively; and grade 1 hypothyroidism in 1 patient.
A literature search of MEDLINE®
References
| 1 | Kibel AS, Gleave M, Brookman-May SD, et al. PROTEUS: a randomized, double-blind, placebo-controlled, phase 3 trial of apalutamide plus androgen deprivation therapy (ADT) vs placebo plus ADT prior to and after radical prostatectomy in patients with localized or locally advanced high-risk prostate cancer. Poster presented at: American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium; February 17-19, 2022; San Francisco, CA. |
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