NCT01913717

Brief Summary

The present research project aims to improve the current treatment for prostate-confined tumor, evaluating the safety and feasibility of a very short hypofractionated radiotherapy schedule administered with one of the best available dose delivery systems. The study will include 2 sub-studies (in-silica and clinical study) and 4 tasks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2013

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

3.5 years

First QC Date

July 30, 2013

Last Update Submit

June 27, 2023

Conditions

Adenocarcinoma of Prostate

Keywords

Prostate cancerRadiotherapyhypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Acute toxicity

    The primary outcome is the acute toxicity according to the validated scale Radiotherapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG / EORTC). It will measure the proportion of patients who experience at least one event of acute toxicity of grade 3 or 4 according to the scale RTOG / EORTC) as the maximum value of toxicity during radiation treatment or within one month after the completion of radiotherapy.

    one month after radiotherapy

Secondary Outcomes (2)

  • late toxicity

    2 years

  • efficacy of treatment

    2 years

Study Arms (1)

External beam radiotherapy

EXPERIMENTAL

External beam radiotherapy

Radiation: External beam radiotherapy

Interventions

External beam radiotherapyRADIATION

The patients will be treated with extreme hypofractionated radiotherapy with the dose delivery system that will result most fit at the in-silica study. Simultaneous Integrated Boost (SIB) technique will be applied to deliver a total dose of 36.25 Gy in 5 fractions (over 10 days) to the whole prostate (7.25 Gy/fraction) and 37.5 Gy to the dominant intraprostatic lesion DIL (7.5 Gy/fraction), profiting of the high sensibility of prostate cancer to high dose/fraction. Several strategies will be applied in order to reduce the dose to the surrounding organs at risk.

Also known as: hypofractionated radiotherapy
External beam radiotherapy

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Histologically confirmed adenocarcinoma of prostate, including the following 2011 National Comprehensive Cancer Network (NCCN) risk categories: very low (T1c PSA \<10 ng/ml, Gleason score \<7, fewer than 3 positive biopsy cores, \<50% cancer in each core, PSA density \<0.15 ng/ml) or low (T1-T2a, PSA \<10 ng/ml, Gleason score \<7) or intermediate (T2b or T2c, PSA between 10 and 20 ng/ml, Gleason score of 7)
  • cN0 and cM0 stage
  • Age \> 18 years
  • Good performance status (ECOG\< 2),
  • No previous pelvic radiotherapy
  • No previous prostatectomy
  • No hormonal treatment (neoadjuvant or concomitant)
  • No concomitant bowel inflammatory disease or other serious comorbidities
  • Good urinary flow (peak flow \> 10 ml/s)
  • No previous invasive cancer (within 5 years before the prostate cancer diagnosis) apart from non-melanoma skin malignancies.

You may not qualify if:

  • Extraprostatic tumor extension (T3) or locally advanced disease (T4)
  • Pelvic lymph node metastasis (N1)
  • Distant metastasis (M1)
  • Urinary obstructive symptoms (IPSS \> 20)
  • Previous pelvic radiotherapy
  • Severe systemic disorders
  • Concomitant disorders including: chronic urinary or intestinal inflammatory conditions (for example, ulcerous recto-colitis, Crohn disease), anti-coagulant treatment (warfarin, heparin)
  • Previous malignancy except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer
  • Non conformity of the radiotherapy dose distribution when compared to the dose constraints
  • Psychiatric disorders or any other condition that can can make unreliable the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

Related Publications (6)

  • Corrao G, Marvaso G, Zaffaroni M, Volpe S, Augugliaro M, Fodor CI, Zerini D, Vingiani A, Mistretta FA, Luzzago S, Alessi S, Pricolo P, Musi G, De Cobelli O, Renne G, Manzoni M, Petralia G, Orecchia R, Jereczek-Fossa BA. Correlation between radiological and biological features and clinical outcomes in early prostate cancer: an exploratory subgroup analysis. Neoplasma. 2022 Mar;69(2):404-411. doi: 10.4149/neo_2021_210622N828. Epub 2022 Jan 12.

    PMID: 35014537DERIVED

  • Marvaso G, Ciardo D, Gandini S, Riva G, Frigo E, Volpe S, Fodor C, Zerini D, Rojas DP, Comi S, Cambria R, Cattani F, Musi G, De Cobelli O, Orecchia R, Jereczek-Fossa BA. Comparison of Outcomes and Toxicity Between Extreme and Moderate Radiation Therapy Hypofractionation in Localized Prostate Cancer: A Propensity Score Analysis. Int J Radiat Oncol Biol Phys. 2019 Nov 15;105(4):735-744. doi: 10.1016/j.ijrobp.2019.07.027. Epub 2019 Aug 1.

    PMID: 31377161DERIVED

  • Cremonesi M, Garibaldi C, Timmerman R, Ferrari M, Ronchi S, Grana CM, Travaini L, Gilardi L, Starzynska A, Ciardo D, Orecchia R, Jereczek-Fossa BA, Leonardi MC. Interim 18F-FDG-PET/CT during chemo-radiotherapy in the management of oesophageal cancer patients. A systematic review. Radiother Oncol. 2017 Nov;125(2):200-212. doi: 10.1016/j.radonc.2017.09.022. Epub 2017 Oct 10.

    PMID: 29029833DERIVED

  • Garibaldi C, Ronchi S, Cremonesi M, Gilardi L, Travaini L, Ferrari M, Alterio D, Kaanders JHAM, Ciardo D, Orecchia R, Jereczek-Fossa BA, Grana CM. Interim 18F-FDG PET/CT During Chemoradiation Therapy in the Management of Head and Neck Cancer Patients: A Systematic Review. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):555-573. doi: 10.1016/j.ijrobp.2017.02.217. Epub 2017 Mar 4.

    PMID: 28581396DERIVED

  • Jereczek-Fossa BA, Fanetti G, Fodor C, Ciardo D, Santoro L, Francia CM, Muto M, Surgo A, Zerini D, Marvaso G, Timon G, Romanelli P, Rondi E, Comi S, Cattani F, Golino F, Mazza S, Matei DV, Ferro M, Musi G, Nole F, de Cobelli O, Ost P, Orecchia R. Salvage Stereotactic Body Radiotherapy for Isolated Lymph Node Recurrent Prostate Cancer: Single Institution Series of 94 Consecutive Patients and 124 Lymph Nodes. Clin Genitourin Cancer. 2017 Aug;15(4):e623-e632. doi: 10.1016/j.clgc.2017.01.004. Epub 2017 Jan 11.

    PMID: 28185875DERIVED

  • Timon G, Ciardo D, Bazani A, Garioni M, Maestri D, De Lorenzo D, Pansini F, Cambria R, Rondi E, Cattani F, Marvaso G, Zerini D, Vischioni B, Ciocca M, Russo S, Molinelli S, Golino F, Scroffi V, Rojas DP, Fodor C, Petralia G, Santoro L, De Cobelli O, Orecchia R, Jereczek-Fossa BA. Rationale and protocol of AIRC IG-13218, short-term radiotherapy for early prostate cancer with concomitant boost to the dominant lesion. Tumori. 2016 Oct 13;102(5):536-540. doi: 10.5301/tj.5000547. Epub 2016 Aug 5.

    PMID: 27514314DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeutics

Study Officials

  • Roberto Orecchia, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

  • BARBARA A JERECZEK, MD PhD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2013

First Posted

August 1, 2013

Study Start

January 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Locations

IT(1)