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Trial record 30 of 1080 for:    prostate cancer AND radiation

Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART3)

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: NCT01578902
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : December 23, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the safety and efficacy of a short course of radiotherapy (35 Gy / 5 fractions / 29 days) for the treatment of low-risk prostate cancer.

Condition or disease Intervention/treatment Phase
Prostate Cancer Radiation: Hypofractionated radiotherapy Phase 1 Phase 2

Detailed Description:

Rationale for Proposed Study With the availability of intensity modulated radiotherapy (IMRT) at the Odette Cancer Centre (OCC), there is an opportunity to explore the use of a much more intensive hypofractionation schedule for prostate cancer. Using an alpha/beta ratio of 1.3, a dose of 35 Gy in 5 fractions would be equivalent to 88 Gy delivered in 2 Gy fractions. For normal tissues (alpha/beta value of 2), this would be equivalent to 78 Gy in 2 Gy fractions. As such, the linear quadratic equation predicts that 35 Gy in 5 fractions should not result in any increased late toxicity for normal tissues compared to standard dose escalated radiotherapy. However, the biological dose to the prostate cancer would be significantly increased. As a safety precaution for this study proposal, the investigators propose to deliver 35 Gy in 5 fractions over 5 weeks (one radiotherapy fraction of 7 Gy per week) to allow for normal tissue repair.

With IMRT, it is expected that there will be superior conformality of the high dose region around the target volume. As well, the use of daily on-line imaging will allow us to eliminate interfraction prostate motion errors and use tighter planning target volume margins for any residual intrafraction motion. At OCC, such an approach has already been shown to be feasible and is currently employed in the phase 1/2 concomitant boost study for high risk prostate cancer.

If proven to be safe and effective, such a hypofractionated radiotherapy schedule may have significant practical advantages as well. With only 1 fraction of radiotherapy delivered each week (for a total of 5 weeks), there are huge savings in resource utilization and increased convenience for patients.

The investigators propose to start a small phase 1 study to explore the use of this dose fractionation for men with low risk prostate cancer. The primary endpoint for this small pilot study would be acute and late normal tissue toxicities. If proven to be feasible and safe, external peer-reviewed funding will be sought to further explore this novel treatment schedule in a larger phase 2 setting.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Accelerated Radiotherapy for Low Risk Localized Prostate Cancer (pHART 3)
Study Start Date : October 2006
Primary Completion Date : April 2008
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Hypofractionated radiation
35 Gy in 5 fractions of image-guided intensity modulated radiotherapy (IGRT) delivered over 29 days.
Radiation: Hypofractionated radiotherapy
35Gy/5 fractions/29 days
Other Name: standard linear accelerator delivery


Outcome Measures

Primary Outcome Measures :
  1. Incidence of grade 3+ rectal toxicity [ Time Frame: Acute period (up to 6 months) ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0


Secondary Outcome Measures :
  1. Incidence of grade 3+ urinary toxicity [ Time Frame: Acute (up to 6 months) and Late (6 months and after) ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

  2. Incidence of grade 3+ rectal and urinary toxicity [ Time Frame: Late (6 months and after) ]
    Common Terminology Criteria for Adverse Events (CTCAE) v3.0

  3. Quality of Life [ Time Frame: up to 5 years ]
    Expanded Prostate Cancer Index Composite (EPIC)

  4. Biochemical (ie. prostate specific antigen) disease free survival [ Time Frame: 5 year ]
  5. Biopsy positive rate [ Time Frame: 3 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent signed (Appendix A)
  • Adult men greater than 18 years of age
  • Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
  • Clinical stage T1-T2b, Gleason Score < 6, and PSA < 10 ng/mL
  • Less than 50% of biopsy cores +ve for cancer
  • Less than 50% overall surface area involved with cancer
  • Neoadjuvant hormone suppression therapy is allowed. However, PSA, must have been performed within 2 months of starting androgen suppression therapy. If androgen suppression therapy has been started LHRH agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion & radiotherapy planning.

Exclusion Criteria:

  • Prior pelvic radiotherapy.
  • Concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)
  • Diagnosis of bleeding diathesis
  • Presence of a hip prosthesis
  • Pelvic girth >40cm (to ensure visibility of gold seeds on electronic portal imaging device)
  • Large prostate (> 60 cm3) on imaging
  • Severe lower urinary tract symptoms (International Prostate Symptom Score > 15 or nocturia > 3)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578902


Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Association of Radiation Oncology
Investigators
Principal Investigator: Andrew Loblaw, MD Sunnybrook Health Sciences Centre
Principal Investigator: Patrick Cheung, MD Sunnybrook Health Sciences Centre
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01578902     History of Changes
Other Study ID Numbers: 1002-2006
First Posted: April 17, 2012    Key Record Dates
Last Update Posted: December 23, 2014
Last Verified: December 2014

Keywords provided by Sunnybrook Health Sciences Centre:
Prostatic Neoplasms
Radiotherapy
Hypofractionation
Low Risk Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases