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. 2022 Nov 29;4(1):20220032.
doi: 10.1259/bjro.20220032. eCollection 2022.

Stereotactic prostate radiotherapy with or without androgen deprivation therapy, study protocol for a phase III, multi-institutional randomized-controlled trial

Marco Lorenzo Bonù  1 , Alessandro Magli  2 , Davide Tomasini  1 , Francesco Frassine  1 , Domenico Albano  3 , Stefano Arcangeli  4 , Alessio Bruni  5 , Stefano Ciccarelli  6 , Martina De Angeli  7 , Giulio Francolini  8 , Ciro Franzese  9 , Paolo Ghirardelli  10 , Luigi Grazioli  11 , Andrea Guerini  1 , Andrea Lancia  12 , Giulia Marvaso  13 , Matteo Sepulcri  14 , Luca Eolo Trodella  15 , Vittorio Morelli  1 , Andrea Georgopulos  1 , Anastasiya Oleksandrivna Domina  1 , Lorenzo Granello  1 , Eneida Mataj  1 , Fernando Barbera  1 , Luca Triggiani  1
Affiliations

Stereotactic prostate radiotherapy with or without androgen deprivation therapy, study protocol for a phase III, multi-institutional randomized-controlled trial

Marco Lorenzo Bonù et al. BJR Open. .

Abstract

Objective: The therapeutic landscape for localized prostate cancer (PC) is evolving. Stereotactic radiotherapy (SRT) has been reported to be at least not inferior to standard radiotherapy, but the effect of androgen deprivation therapy (ADT) in this setting is still unknown and its use is left to clinical judgment. There is therefore the need to clarify the role of ADT in association with SRT, which is the aim of the present study.

Methods: We present a study protocol for a randomized, multi-institutional, Phase III clinical trial, designed to study SRT in unfavorable intermediate and a subclass of high-risk localized PC. Patients (pts) will be randomized 1:1 to SRT + ADT or SRT alone. SRT will consists in 36.25 Gy in 5 fractions, ADT will be a single administration of Triptorelin 22.5 mg concurrent to SRT. Primary end point will be biochemical disease-free survival. Secondary end points will be disease-free survival, freedom from local recurrence, freedom from regional recurrence, freedom from distant metastasis and overall survival (OS); quality of life QoL and patient reported outcomes will be an exploratory end point and will be scored with EPIC-26, EORTC PR 25, IPSS, IIEF questionnaires in SRT + ADT and SRT alone arms. Moreover, clinician reported acute and late toxicity, assessed with CTCAE v. 5.0 scales will be safety end points.

Results: Sample size is estimated of 310 pts. For acute toxicity and quality of life results are awaited after 6 months since last patient in, whereas, for efficacy end points and late toxicity mature results will be available 3-5 years after last patient in.

Conclusion: Evidence is insufficient to guide decision making concerning ADT administration in the new scenario of prostate ultra-hypofractionation. Hence, the need to investigate the ADT role in SRT specific setting.

Advances in knowledge: The stereotactic prostate radiotherapy with or without ADT trial (SPA Trial) has been designed to establish a new standard of care for SRT in localized unfavorable intermediate and a subclass of localized high risk PC.

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Figures

Figure 1.
Figure 1.
Patient pathway in SPA trial protocol.
Figure 2.
Figure 2.
Pre-randomization and follow-up assessment of PSA, testosterone, toxicity, PRO e QoL questionnaires in details. PRO, patient reported outcome; PSA, prostate-specific antigen; QoL, quality of life.
See this image and copyright information in PMC

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References

    1. Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, et al. . 10-Year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. N Engl J Med 2016; 375: 1415–24. doi: 10.1056/NEJMoa1606220 - DOI - PubMed
    1. Dearnaley D, Syndikus I, Mossop H, Khoo V, Birtle A, Bloomfield D, et al. . Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 chhip trial. Lancet Oncol 2016; 17: 1047–60. doi: 10.1016/S1470-2045(16)30102-4 - DOI - PMC - PubMed
    1. Lee WR, Dignam JJ, Amin MB, Bruner DW, Low D, Swanson GP, et al. . Randomized phase III noninferiority study comparing two radiotherapy fractionation schedules in patients with low-risk prostate cancer. J Clin Oncol 2016; 34: 2325–32. doi: 10.1200/JCO.2016.67.0448 - DOI - PMC - PubMed
    1. Catton CN, Lukka H, Gu C-S, Martin JM, Supiot S, Chung PWM, et al. . Randomized trial of a hypofractionated radiation regimen for the treatment of localized prostate cancer. J Clin Oncol 2017; 35: 1884–90. doi: 10.1200/JCO.2016.71.7397 - DOI - PubMed
    1. Jackson WC, Silva J, Hartman HE, Dess RT, Kishan AU, Beeler WH, et al. . Stereotactic body radiation therapy for localized prostate cancer: a systematic review and meta-analysis of over 6,000 patients treated on prospective studies. Int J Radiat Oncol Biol Phys 2019; 104: 778–89: S0360-3016(19)30612-1. doi: 10.1016/j.ijrobp.2019.03.051 - DOI - PMC - PubMed