ARNEO: A Randomized Phase II Trial of Neoadjuvant Degarelix with or Without Apalutamide Prior to Radical Prostatectomy for High-risk Prostate Cancer

Devos, Gaëtan; Tosco, Lorenzo; Baldewijns, Marcella; Gevaert, Thomas; Goffin, Karolien; Petit, Valentin; Mai, Cindy; Laenen, Annouschka; Raskin, Yannic; Haute, Carl Van; Goeman, Lieven; Meerleer, Gert De; Berghen, Charlien; Devlies, Wout; Claessens, Frank; Poppel, Hendrik Van; Everaerts, Wouter; Joniau, Steven

doi:10.1016/j.eururo.2022.09.009

Cited by 37 publications

(20 citation statements)

References 33 publications

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“…After the screening, a full-text review of 30 articles was performed. According to our inclusion criteria, we finally identified 20 studies eligible for systematic review [13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32]. Of the twenty studies, we identified eight phase II RCTs comparing the efficacy and/or safety of ARSI-based combination therapy versus other combinations or ADT/ARSI alone (Table 1) [13][14][15][16][17][18][19][20].…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

“…Several studies assessing the efficacy of neoadjuvant ARSIs used a pathological endpoint as a surrogate for long-term oncological outcomes (Table 2 and Supplementary Tables S3 and S4) [13][14][15][17][18][19]21,22]. However, no consensus yet exists regarding the ideal definition of a pathological response following neoadjuvant hormonal therapy.…”

Section: Pathologic Responsesmentioning

confidence: 99%

“…The definition of MRD differed across studies. Four studies defined the MRD as residual cancer <5 mm as the longest length in the crossing section dimension [13,15,17,18], and one study used the <3 mm cut-off [14], and two studies defined it as RCB < 0.25 cm 3 [18,21]. Following the definition of combined pathologic response (pCR + MDR) reported by McKay et al in 2021 [17], we calculated the combined pathologic response of each study.…”

Section: Pathologic Responsesmentioning

confidence: 99%

“…Most recently, the results from the ARNEO trial led by Devos et al were published [18]. This is a phase II RCT assessing the efficacy of a 3-month neoadjuvant degarelix with or without APA prior to RP in 89 patients with high-risk clinically non-metastatic PCa [18].…”

Section: Single Arsi Plus Adtmentioning

confidence: 99%

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Neoadjuvant Androgen Receptor Signaling Inhibitors before Radical Prostatectomy for Non-Metastatic Advanced Prostate Cancer: A Systematic Review

Yanagisawa

Rajwa

Quhal

et al. 2023

JPM

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(1) Background: Several phase II studies, including randomized controlled trials (RCTs), assessed the efficacy of adding androgen receptor signaling inhibitors (ARSIs) to androgen deprivation therapy (ADT) as a neoadjuvant treatment in patients treated with radical prostatectomy (RP) for prostate cancer (PCa). Summarizing the early results of these studies could help in designing phase III trials and patient counseling. (2) Methods: We queried three databases in January 2023 for studies that included PCa patients treated with neoadjuvant ARSI-based combination therapy before RP. The outcomes of interest were oncologic outcomes and pathologic responses, such as pathologic complete response (pCR) and minimal residual disease (MRD). (3) Results: Overall, twenty studies (eight RCTs) were included in this systematic review. Compared to ADT or ARSI alone, ARSI + ADT was associated with higher pCR and MRD rates; this effect was less evident when adding a second ARSI or chemotherapy. Nevertheless, ARSI + ADT resulted in relatively low pCR rates (0–13%) with a high proportion of ypT3 (48–90%) in the resected specimen. PTEN loss, ERG positive, or intraductal carcinoma seem to be associated with worse pathologic response. One study that adjusted for the effects of possible confounders reported that neoadjuvant ARSI + ADT improved time to biochemical recurrence and metastasis-free survival compared to RP alone. (4) Conclusions: Neoadjuvant ARSI + ADT combination therapy results in improved pathologic response compared to either alone or none in patients with non-metastatic advanced PCa. Ongoing phase III RCTs with long-term oncologic outcomes, as well as biomarker-guided studies, will clarify the indication, oncologic benefits, and adverse events of ARSI + ADT in patients with clinically and biologically aggressive PCa.

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Section: Study Selection and Characteristicsmentioning

confidence: 99%

Section: Pathologic Responsesmentioning

confidence: 99%

Section: Pathologic Responsesmentioning

confidence: 99%

Section: Single Arsi Plus Adtmentioning

confidence: 99%

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Neoadjuvant Androgen Receptor Signaling Inhibitors before Radical Prostatectomy for Non-Metastatic Advanced Prostate Cancer: A Systematic Review

Yanagisawa

Rajwa

Quhal

et al. 2023

JPM

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“…Placebo für 3 Monate untersuchte, zeigen erste Anzeichen, dass eine erweiterte neoadjuvante Hormontherapie möglicherwiese zu besseren pathologischen Ergebnissen nach Prostataektomie führt. 38 % der Patienten, die Apalutamid erhielten, hatten im Prostatektomiepräparat einen Residualtumor ≤ 0,25 cm [ 3 ] im Vergleich zu 9 % der Patienten in der Placebogruppe [ 14 ].…”

Section: Neoadjuvante Therapieunclassified

Multimodale Therapie des Hochrisiko- und lokal fortgeschrittenen Prostatakarzinoms

Preißer

Tilki

2022

Urologie

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Die Behandlung des Hochrisiko- und lokal fortgeschrittenen Prostatakarzinoms stellt eine Herausforderung im ärztlichen Alltag dar. Mit 20–40 % machen Patienten mit solch einem Tumorstadium aktuell einen Großteil an großen operativen Zentren aus. Aufgrund von COVID-19 („coronavirus disease 2019“) ist zu erwarten, dass der Anteil der Patienten in den nächsten Jahren weiter zunehmen wird. Neben einer adäquaten Ausbreitungsdiagnostik ist v. a. die Auswahl der richtigen Therapie entscheidend, um lokale Komplikationen zu vermeiden und ein optimales onkologisches Überleben zu gewährleisten. Oftmals erfolgt die Behandlung mit einem multimodalen Ansatz. Der Stellenwert der erweiterten Hormontherapie im neoadjuvanten Setting wird gerade in großen Phase-III-Studien überprüft und bleibt abzuwarten.

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Adjuvant and salvage radiotherapy after neoadjuvant therapy and radical prostatectomy for high‐risk localized prostate cancer

Ravi,

Kwak,

Devlies

et al. 2023

The Prostate

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BackgroundWe sought to describe patterns of delivery of adjuvant (aRT) and salvage RT (sRT) in patients who underwent RP after receiving neoadjuvant androgen receptor pathway inhibitor (ARPI) before radical prostatectomy (RP) for high‐risk localized prostate cancer (HRLPC).MethodsTwo hundred eighteen patients treated on phase 2 neoadjuvant trials between 2006 and 2018 at two academic centers were evaluated. aRT and sRT were defined as receipt of RT with a PSA of ≤0.1 or >0.1 ng/mL, respectively. Primary outcomes were biochemical recurrence (BCR), defined as time from aRT/sRT to a PSA rising to >0.1 ng/mL, and metastasis‐free survival (MFS) after RT.ResultsTwenty‐three (11%) and 55 (25%) patients received aRT and sRT respectively. Median PSA at start of aRT and sRT was 0.01 and 0.16 ng/mL, and median duration from RP to RT was 5 and 14 months, respectively. All aRT patients had NCCN high‐risk disease, 30% were pN1 and 43% had positive surgical margins; 52% had prostate bed RT. Fifty‐one percent of sRT patients had biopsy Gleason 9–10, 29% were pT2 and 9% had positive surgical margins; 63% had RT to the prostate bed/pelvis. At a median follow‐up of 5.3 and 3.0 years after aRT and sRT, 3‐year freedom from BCR was 55% and 47%, and 3‐year MFS was 56% and 53%, respectively.ConclusionsaRT was infrequently used in patients who received neoadjuvant ARPI before RP for HRLPC. Outcomes of aRT and sRT were similar but generally poor. Studies evaluating intensified systemic therapy approaches with postoperative RT in this high‐risk population are needed.

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ARNEO: A Randomized Phase II Trial of Neoadjuvant Degarelix with or Without Apalutamide Prior to Radical Prostatectomy for High-risk Prostate Cancer

Cited by 37 publications

References 33 publications

Neoadjuvant Androgen Receptor Signaling Inhibitors before Radical Prostatectomy for Non-Metastatic Advanced Prostate Cancer: A Systematic Review

Neoadjuvant Androgen Receptor Signaling Inhibitors before Radical Prostatectomy for Non-Metastatic Advanced Prostate Cancer: A Systematic Review

Multimodale Therapie des Hochrisiko- und lokal fortgeschrittenen Prostatakarzinoms

Adjuvant and salvage radiotherapy after neoadjuvant therapy and radical prostatectomy for high‐risk localized prostate cancer

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