A Phase I-II Study on Stereotactic Body Radiotherapy in 3 Fractions for Low/Int Risk Prostate Cancer

NCT02623647 | Unknown

• 1 other identifier: eHYPO
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The present is a phase I-II study testing the safety and the efficacy of extremely hypofractionated radiotherapy for early stage prostate cancer. The study is designed to assess GU toxicity while controlling tumor control, in terms of survival free from biochemical failure. 40 Gy in fxs will be delivered to patients with low and favourable intermediate risk prostate tumors.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• grade 2+ GU toxicity according to CTCv4.0

  Hematuria (A disorder characterized by laboratory test results that indicate blood in the urine) Urinary incontinence ( A disorder characterized by inability to control the flow of urine from the bladder.)

  1 yr

Secondary Outcomes (1)

• biochemical failure according to Phoenix definition (nadir + 2 ng/ml)

  5-yr

Study Arms (1)

A single-arm, nonrandomized

OTHER

stereotactic body radiotherapy SBRT, 40 Gy for 3 fractions

Radiation: stereotactic body radiotherapy SBRT

Interventions

stereotactic body radiotherapy SBRT RADIATION

40 Gy in 3 fractions to the prostate gland delivered with stereotactic body radiotherapy

A single-arm, nonrandomized

Eligibility Criteria

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

You may qualify if:

• age (\>18 yrs/old)
• low risk prostate cancer defined as primary tumor stage according to AJCC 2010: T1-2a and Gleason Score-GLS: 3+3 and serum Prostate Specific Antigen-PSA: PSA\<10 ng/ml); or among intermediate risk prostate cancer defined as clinical stage T2b-c or GLS 7 or PSA of 10-20 ng/ml, only patients with favourable characteristics: a single factor for intermediate risk AND GLS 3 + 4 AND \<50% of biopsy cores containing cancer (12 cores as a minimum).

You may not qualify if:

• prior radiotherapy
• concomitant androgen deprivation
• pt failure to consent

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• San Giovanni Addolorata Hospital: collaborator
• Azienda Sanitaria-Universitaria Integrata di Udine: collaborator

Study Sites (1)

Regina Elena National Cancer Institute

Rome, 00144, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Giuseppe Sanguineti, MD

  Regina Elena National Cancer Institute, Rome IT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Sanguineti, MD

CONTACT

+390652663010; giuseppe.sanguineti@ifo.gov.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Dept of Radiation Oncology

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 8, 2015
• Study Start: November 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: January 1, 2022
• Last Updated: March 9, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)