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The Precision Prostatectomy: an IDEAL Stage 0, 1 and 2A Study

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The Precision Prostatectomy: an IDEAL Stage 0, 1 and 2A Study Open access Original article BMJ Surg Interv Health Technologies: first published as 10.1136/bmjsit-2019-000002 on 19 August 2019. Downloaded from The Precision Prostatectomy: an IDEAL Stage 0, 1 and 2a Study Akshay Sood, 1 Wooju Jeong,1 Kanika Taneja,2 Firas Abdollah,1 Isaac Palma-Zamora,1 Sohrab Arora,1 Nilesh Gupta,2 Mani Menon1 To cite: Sood A, Jeong W, ABSTRACT Key messages Taneja K, et al. The Precision Objective This study aimed to develop a preclinical model Prostatectomy: an IDEAL Stage of prostate cancer (CaP) for studying focal/hemiablation What is already known about this subject? 0, 1 and 2a Study. BMJ Surg of the prostate (IDEAL stage 0), and to use the information Interv Health Technologies Whole-gland treatment of prostate cancer (CaP) of- from the stage 0 investigation to design a novel focal ► 2019;1:e000002. doi:10.1136/ ten leads to unintended adverse functional effects, surgical treatment approach—the precision prostatectomy bmjsit-2019-000002 in particular, sexual impotence. (IDEAL stage 1/2a). ► Focal ablative techniques for treatment of local- Received 18 March 2019 Methods The IDEAL stage 0 study included simulation ized CaP have recently emerged to avoid such Revised 17 July 2019 of focal/hemiablation in whole-mount prostate functional decline; although these focal ablative Accepted 17 July 2019 specimens obtained from 100 men who had undergone techniques have shown promise, a few limitations radical prostatectomies, but met the criteria for focal/ have emerged: (1) an inability or reluctance to treat hemiablation. The IDEAL stage 1/2a was a prospective, a prostate gland >40 gm, (2) an inability to ablate single-arm, Institutional Review Board-approved study of >60% of the whole gland, (3) lack of pathological precision prostatectomy undertaken in eight men, who information, and (4) a high positive biopsy rate in the met the predetermined criteria. Criteria for both stages residual prostate tissue resulting in a high rate of included (1) prostate-specific antigen (PSA) ≤15 ng/ redo procedures (~25% of the patients). mL, (2) stage ≤cT2, (3) dominant unilateral lesion with Gleason ≤4+3 with any number of cores or % cores What are the new findings? copyright. involved ipsilaterally on transrectal biopsy, (4) no primary ► Precision prostatectomy allows for removal of great- Gleason ≥4 contralaterally on transrectal biopsy, and (5) er than 90% of the prostate with complete removal preoperative erectile function score (International Index of of the side of the dominant lesion, and removal of Erectile Function (IIEF)-5) of ≥17 (out of 25) without PDE- the majority of satellite lesions on the contralateral 5i (applicable only to the stage 1/2a study participants). side. Feasibility and safety of the precision prostatectomy ► All eight patients who underwent precision pros- technique, and short-term urinary, sexual and oncological tatectomy in this exploratory study were continent outcomes were studied. and potent within 12 months from surgery, and no Results Analysis of whole-mount specimens in the patient (out of eight) had clinically significant resid- 100 men showed an index lesion (>1 cm in diameter) in ual cancer or required secondary treatment at a fol- all. Ninety-eight men had satellite lesions smaller than low-up of 30 months. 0.5 cm∧3 in volume—46 on the side of the dominant lesions and 52 in the contralateral lobe. If the men in this How might it impact on clinical practice in the modeling cohort had undergone focal ablation with a foreseeable future? http://sit.bmj.com/ ► Precision prostatectomy may allow patients to http:// dx. doi. org/ 10. 1136/ 5–10 mm untreated margin, all except one would have had ► choose a risk-stratified surgical approach to treat- bmjsit- 2019- 000015 at least Gleason 6 residual cancer. If they had undergone hemiablation with no untreated tissue on the ablated ment of localized CaP. side, 56 men would have had residual cancer on the contralateral side, of whom 21 would have had clinically © Author(s) (or their remain on active surveillance. No man has undergone significant cancer (Gleason 7 or higher). If these men had on October 1, 2021 by guest. Protected employer(s)) 2019. Re-use secondary whole-gland therapy. undergone precision prostatectomy, with preservation permitted under CC BY-NC. No Conclusions Examination of whole-mount radical of 5–10 mm of tissue on the non-dominant side, 10% commercial re-use. See rights prostatectomy specimens in men who fit the conventional and permissions. Published by and 4% would have had Gleason 3+4 and Gleason 4+3 criteria of focal/hemiablation showed that approximately BMJ. disease left behind, respectively. For the stage 1/2a study, 21%–68% of men would have clinically significant CaP 1Vattikuti Urology Institute, the median (IQR) age, PSA and IIEF-5 scores at the time of in the untreated tissue. In a small development cohort, Henry Ford Hospital, Detroit, surgery were 54 (52–57) years, 4.4 (3.8–6.1) ng/mL and precision prostatectomy was technically feasible, with Michigan, USA 24 (23-25), respectively. All eight patients were continent 2 excellent postoperative functional recovery. At 30 months Department of Pathology, Henry and sexually active at 12 months with a median IIEF-5 of follow-up, no patient had clinically significant residual Ford Hospital, Detroit, Michigan, score of 21 (out of 25). At 24–30 months from surgery, USA cancer or required secondary treatment. Pending long- the median PSA was 0.2 (range 0.1–0.7) ng/mL. Six men term follow-up, a risk-stratified surgical approach may had undergone follow-up protocol biopsies, two, with Correspondence to avoid whole-gland therapy and preserve erectile function undetectable PSA, had refused. Two men had residual Dr Akshay Sood; in the majority of men with intermediate-risk CaP. asood1@ hfhs. org Gleason 3+3 cancer, with PSA of 0.7 and 0.4 ng/mL, and Sood A, et al. BMJ Surg Interv Health Technologies 2019;1:e000002. doi:10.1136/bmjsit-2019-000002 1 Open access BMJ Surg Interv Health Technologies: first published as 10.1136/bmjsit-2019-000002 on 19 August 2019. Downloaded from INTRODUCTION 1. Map the CaP lesions, including grade and tumor Whole-gland treatment of localized prostate cancer (CaP) diameter. is associated with a substantial risk of adverse outcomes, 2. Determine the distribution of lesions that were below in particular of erectile dysfunction.1 2 In an attempt to the size limit of mp-MRI detection, usually defined as minimize this, a few investigators have developed tech- 10 mm in diameter or 0.5 cm∧3.18 niques of focal CaP ablation, following the well-estab- 3. Simulate a “what if” scenario to examine residual can- lished organ-preserving treatment paradigms in other cer rates, if these men were treated with focal or hemia- malignancies.3–6 While several techniques have been blation rather than with conventional prostatectomy. described,7 the underlying premise is to treat the index 4. Use the risk estimates generated in this stage to devel- lesion,8 9 where visible on imaging (with focal therapy), op a novel technique—the precision prostatectomy— or one side of the prostate, when lesions are not visible that removes the entire hemi prostate and seminal (hemiablation). vesicle complex on the side of the index lesion, but Clinical studies of focal therapy in CaP, notably of high-in- leaves a thin rim of prostatic capsule (5–10 mm) on the tensity focused ultrasound (HIFU), have shown promise— side contralateral to the dominant lesion. 1-year continence and potency rates have been reported to be 100% and 89%, respectively,10 11 and 5-year metasta- IDEAL stage 1/2a: study population, informed consent and sis-free and cancer-specific survival rates were reported to surgical technique be 98% and 100%, respectively, in a recent multi-institu- We examined the feasibility of precision prostatectomy tional study of HIFU.12 However, certain limitations have in eight carefully selected men who were desirous of emerged: an inability or reluctance to treat a prostate gland focal therapy to the prostate (IDEAL stage 1/2a). These >40 g, (2) an inability to ablate >60% of the whole gland, (3) men were evaluated and treated over a 6-month period, lack of pathological information on the ablated prostatic between January and July 2017, allowing a minimum tissue, and (4) a high positive biopsy rate in the residual follow-up of 24 months. All men placed high priority prostate tissue resulting in a high rate of redo procedures on preservation of erectile function and sought out the (~25% of the patients) at 3 years.13 treating surgeon specifically requesting focal therapy. We undertook a preclinical study to model the oncolog- No man was a candidate for active surveillance, and all ical outcomes of focal/hemiablation in a cohort of men met the following criteria: (1) PSA ≤15 ng/mL, (2) stage who had undergone whole-gland radical prostatectomy ≤cT2, (3) dominant unilateral lesion with Gleason score copyright. for localized CaP, but met the criteria for focal/hemiab- ≤4+3 with any number of cores or % cores involved ipsilat- lation (IDEAL stage 0). We used these data to develop a erally on TRUS prostate biopsy, (4) no primary Gleason technique that would optimize the maintenance of erec- score ≥4 contralaterally on TRUS prostate biopsy, and tile function, while allowing for the maximal removal of (5) preoperatively potent without phosphodiesterase CaP, including the index and most/all satellite lesions type 5 (PDE-5) inhibitors. Data collection was under an (IDEAL stage 1/2a). Our primary intent was the precise ongoing protocol approved by the Institutional Review preservation of erectogenic nerves, hence the term Board, and in compliance with Health Insurance Porta- precision prostatectomy.
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