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Trial record 34 of 1450 for:    prostate cancer AND radiation

Hypofractionated Radiation Therapy in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01764646
Recruitment Status : Active, not recruiting
First Posted : January 9, 2013
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Raymond Miralbell, University Hospital, Geneva

Tracking Information
First Submitted Date  ICMJE December 20, 2012
First Posted Date  ICMJE January 9, 2013
Last Update Posted Date October 15, 2018
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2015)
Tolerance to treatment [ Time Frame: up to 5 years ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
  • Tolerance to treatment [ Time Frame: up to 90 days ]
    Tolerance to treatment (urinary, rectal, sexual): Acute toxicity according to NCI CTCAE version 3.0
  • Tolerance to treatment [ Time Frame: up to 5 years ]
    Tolerance to treatment (urinary, rectal, sexual): Late toxicity according to NCI CTCAE version 3.0
Change History Complete list of historical versions of study NCT01764646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
  • 1. Quality of life [ Time Frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years ]
    Quality of life (EORTC QLQ-C30, Prostate cancer module EORTC QLQ-PR25)
  • 2. Local failure [ Time Frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years ]
    Assessed by digital rectal examination (DRE). MRI or PET-CT with choline or acetate may be a confirmatory option. Biopsy confirmation is required for those patients with exclusive local failures and candidates for local salvage.
  • 3. Biochemical disease-free survival bDFS [ Time Frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years ]
    Phoenix definition (PSA nadir + 2 ng/ml)
  • 4. Metastases-free survival [ Time Frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years ]
    Outcomes 3 or 4 - investigations PET-CT choline
  • 5. Disease-specific survival [ Time Frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years ]
    Alive/dead status, date and cause of death and prostate cancer disease status (outcomes 3/4 and 5).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2013)
  • 1. Quality of life [ Time Frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years ]
    Quality of life (EORTC QLQ-C30, Prostate cancer module EORTC QLQ-PR25)
  • 2. Local failure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 9 days (Treatment arm A) or 28 days (Treatment arm B), 12 weeks, 6, 12, 18 months and yearly thereafter, up to 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypofractionated Radiation Therapy in Prostate Cancer
Official Title  ICMJE Stereotactic Body Radiation Therapy for cT1c - cT3a Prostate Cancer With a Low Risk of Nodal Metastases (≤ 20%, Roach Index): a Novalis Circle Phase II Prospective Randomized Trial
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.

Detailed Description

This protocol presents a randomised phase II study aiming to investigate the tolerance and disease control of extreme hypofractionated RT for prostate cancer by delivering 5 x 7.25 Gy = 36.25 Gy over two alternative time schedules: either over 9 days (study A), or over 28 days once-a-week, the same week-day (study B).

The total dose and fractionation schedules have been chosen based on the assumption of their isoeffectivity regarding potential late rectal effects to be expected with a maximum equivalent dose of 74 Gy in 2 Gy fractions and assuming an alpha/beta = 3 Gy for the rectum.

In both arms, the prescribed dose per fraction to the urethra and the surrounding transitional zone will be dropped from 7.25 Gy to 6.5 Gy with a simultaneous integrated boost (SIB) technique. A dose of 5 x 6.5 Gy is equivalent to 31 x 2 Gy assuming an alpha/beta = 3 Gy for the urethra and equivalent to 37 x 2 Gy assuming an alpha/beta = 1.5 Gy for microscopic tumour foci in the transitional zone surrounding the urethra. The two treatment regimens chosen will each be the object of a separate phase I-II study covered by the same protocol and performed in parallel by the participating centres. Randomised assignment to either of the two studies will be introduced to avoid selection bias in treatment assignment within each centre.

OBJECTIVES:

Primary

  • To determine the risk of urinary, rectal and sexual acute and late toxicities rates in patients receiving two different time schedules of extreme hypofractionated radiation therapy

    • Secondary

  • To determine the Quality of life (EORTC QLQ-C30, Prostate cancer module EORTC QLQ-PR25) in patients receiving two different time schedules of extreme hypofractionated radiation therapy
  • To determine the rate of local failure
  • To determine in the two study arms the biochemical disease-free survival bDFS rate
  • To determine in the two study arms the metastases-free survival rate
  • To determine in the two study arms the disease-specific survival rate

OUTLINE:

This is a multicenter study.

Patients undergo extreme hypofractionated radiation therapy for prostate cancer by delivering 5 x 7.25 Gy = 36.25 Gy over two alternative time schedules:

Experimental Arm A: Over 9 days. Experimental Arm B: Over 28 days once-a-week, the same week-day. All patients will be followed up for at least 18 months to contribute to the analysis of the main endpoints of the study. With reference to the secondary endpoints, follow-up will be extended to 10 years.

Stopping rule: In order to avoid exposure of patients to a treatment that may be unsafe, acute GI and GU toxicity will be continuously monitored with the purpose of assisting in the decision of possibly interrupt recruitment in case of an alarming frequency.To this purpose, the procedure of Ivanova et al., 2005 will be applied.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
5 x 7.25 Gy delivery in 2 alternative time Schedule: over 9 days every other treatment or over 28 days once a week
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malignant Neoplasm of Prostate
  • Local Disease
Intervention  ICMJE
  • Radiation: Intensity modulated radiation therapy
    Minimize radiation doses to surrounding area
  • Radiation: Volumetric modulated arc therapy
    Highly conformational dose distribution
  • Radiation: Image guided radiation therapy
    Follow target by the use of fiducial markers and ERB
Study Arms  ICMJE
  • Experimental: 9 days
    Patients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) once a week over 28 days
    Interventions:
    • Radiation: Intensity modulated radiation therapy
    • Radiation: Volumetric modulated arc therapy
    • Radiation: Image guided radiation therapy
  • Experimental: 28 days
    Patients undergo extreme hypofractionated radiation therapy (Intensity modulated radiation therapy, Volumetric modulated arc therapy, Image guided radiation therapy) other 9 days.
    Interventions:
    • Radiation: Intensity modulated radiation therapy
    • Radiation: Volumetric modulated arc therapy
    • Radiation: Image guided radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 18, 2016)
170
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2013)
152
Estimated Study Completion Date  ICMJE September 2025
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

    1. 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).
    2. Randomization at the end of the neoadjuvant AD period (2 months after starting AD).
    3. 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).

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Finland,   Israel,   Netherlands,   Portugal,   Spain,   Switzerland,   Turkey
Removed Location Countries Denmark
 
Administrative Information
NCT Number  ICMJE NCT01764646
Other Study ID Numbers  ICMJE 11-196
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: No plan to share participant data for now
Responsible Party Raymond Miralbell, University Hospital, Geneva
Study Sponsor  ICMJE Raymond Miralbell
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raymond Miralbell, Pr. University Hospital, Geneva
PRS Account University Hospital, Geneva
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP