Hypofractionated Radiation Therapy in Prostate Cancer

NCT01764646 | Unknown DMC

• 1 other identifier: 11-196
• Study Type: interventional
• Target: 170
• Locations: 8 countries
• Sites: 9

Brief Summary

RATIONALE: It is not yet known whether extreme hypofractionation is equally safe and effective than standard radiation therapy in treating prostate cancer. PURPOSE: This protocol presents a randomised phase II study aiming to investigate the tolerance and disease control of extreme hypofractionated Radiation Therapy for prostate cancer.

Conditions

Malignant Neoplasm of Prostate; Local Disease

Keywords

Prostate cancer; Radiation therapy

Outcome Measures

Primary Outcomes (1)

• Tolerance to treatment

  Tolerance to treatment (urinary, rectal, sexual): Acute (up to 90 days) and late (up to 5 years) toxicity follow-up according to NCI CTCAE version 3.0

  up to 5 years

Secondary Outcomes (5)

• 1. Quality of life

  9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years

• 2. Local failure

  9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years

• 3. Biochemical disease-free survival bDFS

  9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years

• 4. Metastases-free survival

  9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years

• 5. Disease-specific survival

  9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years

Study Arms (2)

9 days

EXPERIMENTAL

Patients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) once a week over 28 days

Radiation: Intensity modulated radiation therapy; Radiation: Volumetric modulated arc therapy; Radiation: Image guided radiation therapy

28 days

EXPERIMENTAL

Patients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) other 9 days.

Radiation: Intensity modulated radiation therapy; Radiation: Volumetric modulated arc therapy; Radiation: Image guided radiation therapy

Interventions

Intensity modulated radiation therapy RADIATION

Minimize radiation doses to surrounding area

28 days; 9 days

Volumetric modulated arc therapy RADIATION

Highly conformational dose distribution

28 days; 9 days

Image guided radiation therapy RADIATION

Follow target by the use of fiducial markers and ERB

28 days; 9 days

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: \>18
• WHO performance status ≤ 2
• Any patient where prophylactic lymph node irradiation is not required, i.e. risk of nodal microscopic involvement ≤ 20% (according to Roach et al (25):
• "N+ (in %) = (Gleason score - 6) x 10 + 2/3 PSA at diagnosis)"
• T-stage: cT1-cT3a.
• Previous TURP is allowed provided there is at least 8 weeks interval with radiotherapy.
• Combined hormonal treatment (Neoadjuvant-concomitant androgen deprivation, AD, for 6 months) is mandatory if two or more of the following tumour characteristics are present: ≥cT2c, Gleason 4+3, PSA \>10 ng/ml, perineural invasion, and/or \>1/3 of positive biopsies. RT shall be delivered between 2 and 3 months (+/- 1 week) after starting AD and according to the following chronologic sequence:
• Neoadjuvant AD for 2 months (30 days of bicalutamide 50mg qd, and a 3-month slow-releasing LH-RH analog to be started 15 days after initiating bicalutamide).
• Randomization at the end of the neoadjuvant AD period (2 months after starting AD).
• Planning RT (to be started within 1 month after randomization (i.e., between the 2nd and 3th month after initiating AD)
• Concomitant and adjuvant HT for 4 more months (a second 3-month slow-releasing LH-RH analog injection).

You may not qualify if:

• Inability to obtain a written informed consent
• Patient preference to be treated with one rather than the other treatment arm.
• WHO performance status \> 2
• cT3b,cT4
• Gleason score ≥8
• Clinical N+ on metastases work-up or N+ risk \>20% (Roach algorithm)
• Severe urinary obstructive symptoms (IPSS symptom index \>19)
• Previous TURP less than 8 weeks before radiotherapy
• Previous prostate surgery other than TURP

Sponsors & Collaborators

• Thomas Zilli: lead

Study Sites (9)

Onze Lieve Vrouwziekenhuis

Aalst, 9300, Belgium

Location

University Hospital

Turku, Finland

Location

Sheba Medical Center

Ramat Gan, Israel

Location

VU University Medical Center

Amsterdam, Netherlands

Location

Portuguese Institut of Oncology

Porto, Portugal

Location

Teknon Oncologic Institute

Barcelona, Spain

Location

Hospital Universitario Sanchinarro

Madrid, Spain

Location

University Hospital

Geneva, 1211, Switzerland

Location

Neolife Medical Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy, Intensity-Modulated; Radiotherapy, Image-Guided

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, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Thomas Zilli, Dr

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Model Details: 5 x 7.25 Gy delivery in 2 alternative time Schedule: over 9 days every other treatment or over 28 days once a week

Study Record Dates

• First Submitted: December 20, 2012
• First Posted: January 9, 2013
• Study Start: September 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: September 1, 2025
• Last Updated: May 19, 2020

Record last verified: 2020-05

Locations

ES (2); IL (1); PT (1); NL (1); CH (1); BE (1); FI (1); TU (1)