Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer (HEAT)
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|ClinicalTrials.gov Identifier: NCT01794403|
Recruitment Status : Recruiting
First Posted : February 18, 2013
Last Update Posted : December 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: Extended Hypofractionation Radiotherapy Radiation: Accelerated Hypofractionation Radiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||456 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Study of Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer|
|Actual Study Start Date :||April 4, 2013|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
Experimental: Extended Hypofractionation Radiotherapy (EHRT) Group
Participants in this group will receive the EHRT intervention over a period of 6 weeks.
Radiation: Extended Hypofractionation Radiotherapy
A total dose of 70.2 Gy will be delivered in 26 fractions, 2.7 Gy to the Planning Target Volume (PTV) by Intensity Modulated Radiotherapy (IMRT) with stationary gantry or rotating gantry technique.
Other Name: EHRT
Experimental: Accelerated Hypofractionation Radiotherapy (AHRT) Group
Participants in this group will receive the AHRT intervention over a period of 2 weeks.
Radiation: Accelerated Hypofractionation Radiotherapy
A total dose of 36.25 Gy will be delivered in 5 fractions, 7.25 Gy each to the Planning Target Volume (PTV), by Stereotactic Body Radiotherapy (SBRT) techniques.
Other Name: AHRT
- Percentage of participants achieving two-year failure. [ Time Frame: Up to 2 years ]Reported will be the percentage of participants achieving either a biochemical or clinical failure or positive biopsy. Biochemical Failure will be evaluated using the Phoenix definition wherein failure occurs when the Prostate Specific Antigen (PSA) is ≥ 2 ng/ml more than the lowest PSA measurement before the current one. Clinical failure will be reported as any clinical evidence of local progression or recurrence. A positive biopsy will be concluded via histological evaluation.
- Incidence of treatment related adverse events. [ Time Frame: 2 years ]Toxicity will be reported as the incidence of treatment related grade 2 or higher gastrointestinal (GI) or genitourinary (GU) toxicity. Toxicity will be assessed using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Percentage of Participants achieving failure [ Time Frame: Up to 2 years ]Efficacy will be reported as the percentage of participants achieving biochemical or clinical failure between participants with low and early intermediate risk for prostate cancer. Biochemical Failure will be evaluated using the Phoenix definition wherein failure occurs when the Prostate Specific Antigen (PSA) is ≥ 2 ng/ml more than the lowest PSA measurement before the current one. Clinical failure will be reported as any clinical evidence of local progression or recurrence.
- Mortality Rate [ Time Frame: Up to 5.25 years ]Rate of death from prostate cancer will be reported.
- Overall Survival [ Time Frame: Up to 5.25 years ]Overall survival will be reported as the elapsed time from randomization to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.
- Percentage of participants achieving ASTRO-defined biochemical failure [ Time Frame: Up to 5.25 years ]American Society for Therapeutic Radiation and Oncology (ASTRO) Consensus Definition (ACD) failure is defined as three consecutive rises in post-treatment PSA, measured at the specified follow-up intervals.
- HRQOL as assessed by MAX-PC questionnaire [ Time Frame: Up to 5.25 years ]Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
- HRQOL as assessed by EPIC-SF-12 questionnaire [ Time Frame: Up to 5.25 years ]Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. The questionnaire has 5 subscales (Urinary Function, Urinary Symptoms, Bowel Habits, Sexual Function and Hormonal Function). Each subscale has a total score ranging from 0-100, with higher scores representing better HRQOL.
- Incidence of late-occurring treatment related adverse events [ Time Frame: Up to 5.25 years ]Late occurring toxicity will be reported as the incidence of treatment related grade 2 or higher gastrointestinal (GI) or genitourinary (GU) toxicity occurring more than three months after treatment completion. Toxicity will be assessed using the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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): NCT01794403
|Contact: Jacqueline Rodriguez Amadofirstname.lastname@example.org|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Jacqueline C Rodriguez Amado 305-243-5620 email@example.com|
|Principal Investigator: Matthew Abramowitz, MD|
|Principal Investigator: Alan Pollack, MD, PhD|
|Australia, New South Wales|
|Northern Sydney Local Health District - Royal North Shore Hospital||Recruiting|
|St. Leonards, New South Wales, Australia, 2065|
|Contact: Thomas Eade, M.B.B.S. Thomas.Eade@health.nsw.gov.au|
|Contact: Clare Banks Clare.Banks@health.nsw.gov.au|
|Principal Investigator: Thomas Eade, M.B.B.S.|
|A.O.U. Città della Salute e della Scienza di Torino - University Hospital Trust of Turin||Recruiting|
|Contact: Umberto Ricardi, MD firstname.lastname@example.org|
|Contact: Gabriella Furfaro 011-633-4119 email@example.com|
|Principal Investigator: Umberto Ricardi, MD|
|Sub-Investigator: Mario Levis, MD|
|Sub-Investigator: Alessia Guarnei, MD|
|Sub-Investigator: Sara Bartoncini, MD|
|Principal Investigator:||Matthew Abramowitz, MD||University of Miami|
|Principal Investigator:||Alan Pollack, MD, PhD||University of Miami|