Randomized MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy (BLaStM)
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|ClinicalTrials.gov Identifier: NCT02307058|
Recruitment Status : Recruiting
First Posted : December 3, 2014
Last Update Posted : March 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Radiation: LEAD RT Radiation: HEIGHT RT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Trial of MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy - The Miami BLaStM Trial|
|Actual Study Start Date :||February 5, 2015|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2028|
Experimental: LEAD RT Group
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.
Radiation: LEAD RT
The multiparametric-MRI (MP-MRI) defined Gross Tumor Volume (GTV) will receive 12-14 Gy on the first day of treatment and then the prostate plus proximal seminal vesicles (SV), the Clinical Target Volume (CTV)1, will receive 76 Gy in 38 fractions (Fxs) at 2.0 Gy per Fx. For High Risk patients, the distal SVs may be treated to 56 Gy in 38 Fxs or full dose (CTV2), and the pelvic lymph nodes may be treated to 56 Gy in 38 Fxs (CTV3).
Other Name: Stereotactic Lattice Radiation Therapy
Experimental: HEIGHT RT Group
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.
Radiation: HEIGHT RT
The MRI defined GTV(s) will receive a higher dose per day than the CTV by dose painting. The GTV(s) will receive an absolute dose of 91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 98.5 Gy in 2.0 Gy fractions. The prostate plus proximal seminal vesicles (CTV1) will receive 76 Gy in 38 fractions (Fxs) at 2.0 Gy per Fx. For High Risk patients, the distal SVs (CTV2) may be treated to 56 Gy in 38 Fxs or full dose, and the pelvic lymph nodes (CTV3) may be treated to 56 Gy in 38 Fxs.
Other Name: Moderate Hypofractionation Radiation Therapy
- Rate of Prostate Tumor PathCR [ Time Frame: Up to 3 years ]Prostate Tumor Pathologic Complete Response (PathCR) will be measured using standard ultrasound guided systematic prostate biopsy.
- Correlation between Pathologic Complete Response (PathCR) and Changes in serial post-RT MRIs [ Time Frame: 3 months post-RT, 9-months post-RT, within 3 months of 2-2.5 post-treatment biopsy ]To establish the relationship between PathCR 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 gene/biomarker expression [ Time Frame: 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 [ Time Frame: 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.
- Change in CTC Levels [ Time Frame: Baseline (pre-treatment), Up to 2 years (post-treatment) ]Circulating Tumor Cell (CTC) levels evaluated from peripheral blood samples.
- Change in CCAF Levels [ Time Frame: Baseline (pre-treatment), Up to 2 years (post-treatment) ]Circulating Cancer Associated Fibroblasts (CCAF) levels evaluated from peripheral blood samples.
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): NCT02307058
|Contact: Pavel Noa Hechavarriafirstname.lastname@example.org|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Pavel Noa Hechavarria 305-243-1036 email@example.com|
|Principal Investigator: Alan Pollack, MD|
|Principal Investigator: Matthew Abramowitz, MD|
|Principal Investigator:||Alan Pollack, MD, PhD||University of Miami|