Randomized MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy

Not Applicable

Recruiting

• Conditions: Prostate Cancer
• Interventions: Radiation: HEIGHT RT; Radiation: LEAD RT

• Registration Number: NCT02307058
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this research study is to learn about: 1) improving control of prostate cancer using an extra high dose radiation treatment to the MRI defined high risk tumor areas, in addition to the standard radiation treatment to the rest of the prostate; 2) preserving quality of life by reducing dose to the nearby organs at risk around the prostate; and 3) establishing the relationship of pre- and post-treatment MRI to MRI-directed biopsy results at 2-2.5 years after treatment.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-03
• Study Start: 2015-02-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2027-07-31
• Study Completion: 2031-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 164

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HEIGHT RT Group	HEIGHT RT	Participants in this group will receive the Hypofractionated Extended Image-Guided Highly Targeted (HEIGHT) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 7 and a half weeks.
LEAD RT Group	LEAD RT	Participants in this group will receive the Lattice Extreme Ablative Dose (LEAD) radiotherapy. Radiotherapy will begin within two months of fiducial marker placement. The therapy will consist of 39 fractions over approximately 8 weeks.

Primary Outcome Measures

Name	Time	Method
Rate of Early Prostate Tumor Response (EPTR)	Up to 3 years	Prostate Tumor Pathologic Complete Response (PathCR measured using ultrasound guided systematic prostate biopsy) and/or early biochemical response at 9 months post-RT.

Secondary Outcome Measures

Name	Time	Method
Correlation between EPTR and Changes in serial post-RT MRIs	3 months post-RT, 9-months post-RT, within 3 months of 2-2.5 post-treatment biopsy	To establish the relationship between EPTR and changes in serial post-RT MRI's obtained at 3 months and 9 months after RT, and within 3 months prior to the primary endpoint post-treatment prostate biopsy at 2.0-2.5 yr after completion of all therapy.
Number of participants experiencing treatment related adverse events	Up to 2 years	Number of participants experiencing acute and late toxicity will be evaluated by treating physicians
Health-Related Quality of Life Scores: EPIC SF-12	Up to 5.25 years (post-treatment)	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. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Health-Related Quality of Life Scores: MAX-PC	Up to 5.25 years (post-treatment)	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.
Health-Related Quality of Life Scores: IPSS	Up to 5.25 years (post-treatment)	Health-related quality of life (HRQOL) will be measured using the International Prostate Symptom Score (IPSS) to evaluate patient urinary function and quality of life. There are 7 questions related to urinary function. Responses are on a scale from 0 ("not at all") to 5 ("almost always"), with higher scores indicating higher levels of urinary dysfunction. There is 1 quality of life question related to urinary symptoms. Responses are on a scale from 0 ("delighted") to 6 ("terrible").
Change in CTC Levels	Baseline (pre-treatment), Up to 2 years (post-treatment)	Circulating Tumor Cell (CTC) levels evaluated from peripheral blood samples.
Change in gene/biomarker expression	Baseline, Up to 5.25 years (post-treatment)	Change in gene/biomarker expression in different MP-MRI tumor regions assessed from prostate biopsy samples.
Rate of participant response	Up to 5.25 years (post-treatment)	Participant response will be reported as the percentage of participants with reported biochemical failure (defined as having an increase of 2 ng/mL PSA levels from nadir), clinical failure (defined as having evidence of distant metastasis and overall failure), cause specific mortality and overall mortality.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States