Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence

Recently, the Radiation Oncology Department at Fondazione IRCCS San Gerardo dei Tintori has been renovated and has been equipped with cutting edge technologies to treat prostate cancer. Specifically, the now available technology can track organ motion in real time, thus allowing improved precision in radiation delivery, with increased protection of the surrounding organs at risk. These facilities have already enabled the kickoff of two prospective observational trials, the ABRUPT and the POPART, which are currently ongoing in the treatment of intact prostate and the biochemical recurrence, respectively. Taken together, these observations provide the basis for the prospective clinical study herein proposed. Patients enrolled in the study will undergo salvage single stereotactic RT to the prostate bed by means of image guided volumetric intensity-modulated arc technique (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures, with emphasis on normal tissue sparing and and pinpoint delivery accuracy via the use of devices that ensure stability and beam location reproducibility

Sex

Male

Minimum age

18 Years

Maximum age

90 Years

Inclusion Criteria:

* Subjects of male sex ≥ 18 years of age.
* Subjects have freely signed the pertinent informed consent before the beginning of the study

  * Adenocarcinoma of the prostate treated with radical prostatectomy (any type of radical prostatectomy is permitted including retropubic, perineal, laparoscopic or robotically assisted; there is no time limit for the date of radical prostatectomy)
  * Detectable post-prostatectomy PSA of ≥ 0.1 - \< 2.0 ng/mL either (1) persistently detectable post-operatively or (2) developing biochemical recurrence after prostatectomy (initially undetectable)
  * No evidence of N1 and/or M1 disease assessed by PSMA PET-CT within 90 days prior to registration
  * Negative Magnetic Resonance Imaging (MRI) of the pelvis in case of equivocal evidence of local relapse on PSMA PET-CT
  * Androgen deprivation therapy (ADT) allowed as per physician's discretion
  * ECOG performance status of 0-1
  * Ability to complete the questionnaires

Exclusion Criteria:

* N1 and or M1 patients
* Macroscopic local relapse at pelvic MRI.
* Prior radiation of any kind to the prostate gland or pelvis
* Prior brachytherapy
* History of inflammatory colitis or other active severe comorbidities
* Patients who are on immunosuppressant medication

• BACKGROUNDMa TM, Ballas LK, Wilhalme H, Sachdeva A, Chong N, Sharma S, Yang T, Basehart V, Reiter RE, Saigal C, Chamie K, Litwin MS, Rettig MB, Nickols NG, Yoon SM, Smith L, Gao Y, Steinberg ML, Cao M, Kishan AU. Quality-of-Life Outcomes and Toxicity Profile Among Patients With Localized Prostate Cancer After Radical Prostatectomy Treated With Stereotactic Body Radiation: The SCIMITAR Multicenter Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2023 Jan 1;115(1):142-152. doi: 10.1016/j.ijrobp.2022.08.041. Epub 2022 Aug 23. PMID 36007724
• BACKGROUNDDess RT, Sun Y, Jackson WC, Jairath NK, Kishan AU, Wallington DG, Mahal BA, Stish BJ, Zumsteg ZS, Den RB, Hall WA, Gharzai LA, Jaworski EM, Reichert ZR, Morgan TM, Mehra R, Schaeffer EM, Sartor O, Nguyen PL, Lee WR, Rosenthal SA, Michalski JM, Schipper MJ, Dignam JJ, Pisansky TM, Zietman AL, Sandler HM, Efstathiou JA, Feng FY, Shipley WU, Spratt DE. Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. JAMA Oncol. 2020 May 1;6(5):735-743. doi: 10.1001/jamaoncol.2020.0109. PMID 32215583
• BACKGROUNDBurdett S, Fisher D, Parker CC, et al. LBA64 duration of androgen suppression with post-operative radiotherapy (DADSPORT): a collaborative meta-analysis of aggregate data. Ann Oncol. 2022;33(7):S1428-S1429
• BACKGROUNDFerrario F, Franzese C, Faccenda V, Vukcaj S, Belmonte M, Lucchini R, Baldaccini D, Badalamenti M, Andreoli S, Panizza D, Magli A, Scorsetti M, Arcangeli S. Toxicity profile and Patient-Reported outcomes following salvage Stereotactic Ablative Radiation Therapy to the prostate Bed: The POPART multicentric prospective study. Clin Transl Radiat Oncol. 2023 Nov 25;44:100704. doi: 10.1016/j.ctro.2023.100704. eCollection 2024 Jan. PMID 38111610
• BACKGROUNDLucchini R, Franzese C, Vukcaj S, Purrello G, Panizza D, Faccenda V, Andreoli S, Poli GL, Baldaccini D, Lo Faro L, Tomatis S, Cazzaniga LF, Scorsetti M, Arcangeli S. Acute Toxicity and Quality of Life in a Post-Prostatectomy Ablative Radiation Therapy (POPART) Multicentric Trial. Curr Oncol. 2022 Nov 30;29(12):9349-9356. doi: 10.3390/curroncol29120733.