ABlative Radiotherapy (for) Unfavorable Prostate Tumors

NCT04831983 | Recruiting DMC

• 1 other identifier: ABRUPT
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Published clinical evidence confirms that a single dose of 24 Gy provides unprecedented long-term local control in primary and metastatic prostate cancer with safe toxicity profiles, provided that exposure of surrounding healthy tissues is critically assessed with fulfillment of strict constraints and dose distribution is accomplished using image guidance and tracking tools. In the present trial, intermediate unfavorable and selected high-risk organ-confined prostate cancer patients will undergo Single Dose Radiation Therapy (SDRT) With Focal Boost to the MRI-defined Macroscopic Tumor Volume by means of image-guided volumetric intensity-modulated arc radiotherapy (IGRT-VMAT) and state-of-the-art treatment-planning and quality assurance procedures. Androgen Deprivation Therapy (ADT) type and duration has been set as per standard of care, in accordance with current recommendations and guidelines.

Conditions

Prostate Cancer

Keywords

Unfavorable Prostate Tumors; Stereotactic Body Radiotherapy (SBRT); Volumetric Modulated Arc Therapy (VMAT); Prostate Imaging Reporting and Data System (PI-RADS); Toxicity; Quality of Life

Outcome Measures

Primary Outcomes (1)

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

  To assess treatment related gastrointestinal (GI) and genitourinary (GU) toxicity for patients who undergo SD RT with focal boost on dominant lesion(s) for intermediate unfavorable and selected high risk organ-confined prostate cancer.

  60 months

Secondary Outcomes (5)

• QUALITY OF LIFE (QOL) assessed by Expanded Prostate Cancer Index Composite (EPIC-26) Questionnaire. For each domain minimum symptom score (=0) means best QOL and maximum symptom score (=12) means worst QOL

  60 months

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

  60 months

• Number of participants with voiding symptoms assessed by International Prostatic Symptoms Score (IPSS), ranging from 0 (best) to 35 (worst)

  60 months

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

  60 months

• Number of participants with biochemical relapse assessed by PSA (Phoenix definition)

  60 months

Eligibility Criteria

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

Study Population

Unfavorable Intermediate and Selected High Risk Prostate Cancer (no cT3b and PSA \> 20 ng/mL allowed), as per NCCN definition

You may qualify if:

• Histologically proven prostate adenocarcinoma;
• Intermediate and High risk disease, as per the NCCN definition;
• N0M0 at staging with standard techniques (Bone Scan and Abdominal CT) or (preferably) Choline or PSMA PET-CT;
• ECOG performance status between 0 and 2;
• Life expectancy of \> 5 years, in the opinion of the investigator;
• IPSS score must be ≤ 19 (alpha blockers allowed);

You may not qualify if:

• ≥T3b disease according to the 8th AJCC classification;
• PSA\>20 ng/ml at any time point;
• Previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy);
• Previous radiotherapy to the pelvis;
• Previous invasive malignancy unless disease free for a minimum of 5 years;
• Active Crohn's Disease or Ulcerative Colitis;

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Radiation Oncology, ASST Monza (University of Milan Bicocca)

Monza, MB, 20900, Italy

RECRUITING

Related Publications (9)

• Bodo S, Campagne C, Thin TH, Higginson DS, Vargas HA, Hua G, Fuller JD, Ackerstaff E, Russell J, Zhang Z, Klingler S, Cho H, Kaag MG, Mazaheri Y, Rimner A, Manova-Todorova K, Epel B, Zatcky J, Cleary CR, Rao SS, Yamada Y, Zelefsky MJ, Halpern HJ, Koutcher JA, Cordon-Cardo C, Greco C, Haimovitz-Friedman A, Sala E, Powell SN, Kolesnick R, Fuks Z. Single-dose radiotherapy disables tumor cell homologous recombination via ischemia/reperfusion injury. J Clin Invest. 2019 Feb 1;129(2):786-801. doi: 10.1172/JCI97631. Epub 2019 Jan 14.

  PMID: 30480549 RESULT

• Zelefsky MJ, Greco C, Motzer R, Magsanoc JM, Pei X, Lovelock M, Mechalakos J, Zatcky J, Fuks Z, Yamada Y. Tumor control outcomes after hypofractionated and single-dose stereotactic image-guided intensity-modulated radiotherapy for extracranial metastases from renal cell carcinoma. Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1744-8. doi: 10.1016/j.ijrobp.2011.02.040. Epub 2011 May 17.

  PMID: 21596489 RESULT

• Brand DH, Tree AC, Ostler P, van der Voet H, Loblaw A, Chu W, Ford D, Tolan S, Jain S, Martin A, Staffurth J, Camilleri P, Kancherla K, Frew J, Chan A, Dayes IS, Henderson D, Brown S, Cruickshank C, Burnett S, Duffton A, Griffin C, Hinder V, Morrison K, Naismith O, Hall E, van As N; PACE Trial Investigators. Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2019 Nov;20(11):1531-1543. doi: 10.1016/S1470-2045(19)30569-8. Epub 2019 Sep 17.

  PMID: 31540791 RESULT

• Foerster R, Zwahlen DR, Buchali A, Tang H, Schroeder C, Windisch P, Vu E, Akbaba S, Bostel T, Sprave T, Zamboglou C, Zilli T, Stelmes JJ, Telkhade T, Murthy V. Stereotactic Body Radiotherapy for High-Risk Prostate Cancer: A Systematic Review. Cancers (Basel). 2021 Feb 12;13(4):759. doi: 10.3390/cancers13040759.

  PMID: 33673077 RESULT

• Jackson WC, Silva J, Hartman HE, Dess RT, Kishan AU, Beeler WH, Gharzai LA, Jaworski EM, Mehra R, Hearn JWD, Morgan TM, Salami SS, Cooperberg MR, Mahal BA, Soni PD, Kaffenberger S, Nguyen PL, Desai N, Feng FY, Zumsteg ZS, Spratt DE. 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 Jul 15;104(4):778-789. doi: 10.1016/j.ijrobp.2019.03.051. Epub 2019 Apr 6.

  PMID: 30959121 RESULT

• Lukka HR, Pugh SL, Bruner DW, Bahary JP, Lawton CAF, Efstathiou JA, Kudchadker RJ, Ponsky LE, Seaward SA, Dayes IS, Gopaul DD, Michalski JM, Delouya G, Kaplan ID, Horwitz EM, Roach M 3rd, Pinover WH, Beyer DC, Amanie JO, Sandler HM, Kachnic LA. Patient Reported Outcomes in NRG Oncology RTOG 0938, Evaluating Two Ultrahypofractionated Regimens for Prostate Cancer. Int J Radiat Oncol Biol Phys. 2018 Oct 1;102(2):287-295. doi: 10.1016/j.ijrobp.2018.06.008. Epub 2018 Jun 18.

  PMID: 29913254 RESULT

• Morgan SC, Hoffman K, Loblaw DA, Buyyounouski MK, Patton C, Barocas D, Bentzen S, Chang M, Efstathiou J, Greany P, Halvorsen P, Koontz BF, Lawton C, Leyrer CM, Lin D, Ray M, Sandler H. Hypofractionated Radiation Therapy for Localized Prostate Cancer: An ASTRO, ASCO, and AUA Evidence-Based Guideline. J Clin Oncol. 2018 Oct 11;36(34):JCO1801097. doi: 10.1200/JCO.18.01097. Online ahead of print. No abstract available.

  PMID: 30307776 RESULT

• Macias VA, Barrera-Mellado I. Ultra-hypofractionated radiation therapy for unfavourable intermediate-risk and high-risk prostate cancer is safe and effective: 5-year outcomes of a phase II trial. BJU Int. 2020 Feb;125(2):215-225. doi: 10.1111/bju.14925. Epub 2019 Nov 8.

  PMID: 31614071 RESULT

• Widmark A, Gunnlaugsson A, Beckman L, Thellenberg-Karlsson C, Hoyer M, Lagerlund M, Kindblom J, Ginman C, Johansson B, Bjornlinger K, Seke M, Agrup M, Fransson P, Tavelin B, Norman D, Zackrisson B, Anderson H, Kjellen E, Franzen L, Nilsson P. Ultra-hypofractionated versus conventionally fractionated radiotherapy for prostate cancer: 5-year outcomes of the HYPO-RT-PC randomised, non-inferiority, phase 3 trial. Lancet. 2019 Aug 3;394(10196):385-395. doi: 10.1016/S0140-6736(19)31131-6. Epub 2019 Jun 18.

  PMID: 31227373 RESULT

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

+39 039-2333663; 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: March 30, 2021
• First Posted: April 5, 2021
• Study Start: April 15, 2021
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: January 3, 2024

Record last verified: 2024-01

Locations

IT (1)