Salvage Ultrahypofractionated Postoperative External Radiotherapy For Biochemical Recurrence

NCT06941363 | Recruiting

• 1 other identifier: SUPERB
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer (Post Prostatectomy)

Keywords

biochemical recurrence; salvage RT; toxicity profile; oncological outcomes; linac-based SBRT

Outcome Measures

Primary Outcomes (1)

• Number of participants with acute treatment-related adverse events as assessed by CTCAE v. 5.0

  To prospectively evaluate the cumulative incidence of acute (\< 90 days from the end of treatment) genitourinary (GU) and gastrointestinal (GI) treatment-related toxicities and adverse events. Toxicity assessments are performed at baseline, end of treatment, and at 1, 2, and 3 months after radiotherapy.

  3 months

Secondary Outcomes (5)

• Number of participants with late treatment-related adverse events as assessed by CTCAE v.5.0

  1, 2 and 5 years

• QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-CP) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL

  3 months, 1, 2 and 5 years

• Number of participants with urinary incontinence assessed by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), ranging from 0 (best) to 21 (worst)

  3 months, 1, 2 and 5 years

• Number of participants with erectile dysfunction assessed by International Index of Erectile Function Questionnaire ranging from 5 (worst ) to 25 (best)

  3 months, 1, 2 and 5 years

• Number of participants with biochemical relapse assessed by PSA (cut off 0.20 ng/mL)

  2 and 5 years

Study Arms (1)

1 fx SDRT

Radiation: SDRT

Interventions

SDRT RADIATION

Salvage Single Dose Radiation Therapy (SDRT) to the prostate bed up to 17 Gy

1 fx SDRT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with biochemical relapse following radical prostatectomy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Radiation Oncology, Fondazione IRCCS San Gerardo dei Tintori (University of Milan Bicocca)

Monza, Italy, 20900, Italy

RECRUITING

Related Publications (6)

• Ma 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 BACKGROUND

• Dess 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 BACKGROUND

• Burdett 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

  BACKGROUND

• Ferrario 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 BACKGROUND

• Lucchini 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.

  PMID: 36547147 BACKGROUND

• Buyyounouski MK, Pugh SL, Chen RC, Mann MJ, Kudchadker RJ, Konski AA, Mian OY, Michalski JM, Vigneault E, Valicenti RK, Barkati M, Lawton CAF, Potters L, Monitto DC, Kittel JA, Schroeder TM, Hannan R, Duncan CE, Rodgers JP, Feng F, Sandler HM. Noninferiority of Hypofractionated vs Conventional Postprostatectomy Radiotherapy for Genitourinary and Gastrointestinal Symptoms: The NRG-GU003 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2024 May 1;10(5):584-591. doi: 10.1001/jamaoncol.2023.7291.

  PMID: 38483412 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Stefano Arcangeli, MD

CONTACT

+39 0392333663; stefano.arcangeli@unimib.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): May 1, 2033
• Study Completion (Estimated): May 1, 2033
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

IT (1)