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

Primary Purpose

Prostate Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

LEAD RT

HEIGHT RT

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Eligibility Criteria:

A. Biopsy confirmed adenocarcinoma (including ductal) of the prostate.
B. T1-T3 disease based on digital rectal exam.
C. No evidence of metastasis by any clinical criteria or available radiographic tests (N0M0 by clinical or imaging criteria).
D. Gleason score 6-10.
E. Androgen deprivation therapy (ADT) is at the discretion of the treating physician; but, must be decided (none, short-term or long-term as counted from the luteinizing hormone-releasing hormone (LHRH) agonist or antagonist injection) prior to enrollment. An anti-androgen (e.g., bicalutamide at 50 mg per day po) is recommended to start prior to LHRH agonist injection (not recommended for LHRH antagonist injection) and is recommended to not be administered for more than 4 months. If ADT is planned, the following restrictions apply:
- i. It may be initiated no more than 3 months prior to the signing of consent
- ii. It must be started prior to the start of radiotherapy and
- iii. The total length planned must be ≤ 30 months
F. Prostate-specific Antigen (PSA) ≤ 100 ng/mL within (+/-) 4 months of signing of consent. If PSA was above 100 and drops to ≤ 100 with antibiotics, this is acceptable for enrollment.
G. Subjects with T3 disease based on digital rectal exam (DRE), Gleason 8-10 or a PSA of >15 ng/ml, should have a bone scan within (+/-) 4 months of signing of consent that is without evidence of metastasis. A questionable bone scan is acceptable if additional imaging studies (e.g., plain x-rays, CT, or MRI) do not confirm for metastasis.
H. Suspicious peripheral zone or central gland lesion on MP-MRI
- i. Peripheral zone: Distinct lesion on dynamic contrast-enhanced MRI (DCE-MRI) with early enhancement and later washout (Note: contrast not required for enrollment), and/or distinct lesion on the ADC map (Value <1000).
- ii. Central gland: A suspicious central gland lesion on MP-MRI must have a distinct lesion on the apparent diffusion coefficient (ADC) map (Value <1000)
I. No previous pelvic radiotherapy.
J. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable).
K. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible.
L. Ability to understand and the willingness to sign a written informed consent document.
M. Zubrod performance status ≤ 2. (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod).
N. Willingness to fill out quality of life/psychosocial forms.
O. Age ≥ 35 and ≤ 85 years at signing of consent.

Sites / Locations

University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

LEAD RT Group

HEIGHT RT Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of Early Prostate Tumor Response (EPTR)

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

Correlation between EPTR and Changes in serial post-RT MRIs

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

Number of participants experiencing acute and late toxicity will be evaluated by treating physicians

Health-Related Quality of Life Scores: EPIC SF-12

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

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

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

Change in gene/biomarker expression in different MP-MRI tumor regions assessed from prostate biopsy samples.

Rate of participant response

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

Circulating Tumor Cell (CTC) levels evaluated from peripheral blood samples.

Full Information

NCT ID

NCT02307058

First Posted

December 1, 2014

Last Updated

May 1, 2023

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT02307058

Brief Title

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

Acronym

BLaStM

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 5, 2015 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

June 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LEAD RT Group

Arm Type

Experimental

Arm Description

Arm Title

HEIGHT RT Group

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

LEAD RT

Other Intervention Name(s)

Stereotactic Lattice Radiation Therapy

Intervention Description

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).

Intervention Type

Radiation

Intervention Name(s)

HEIGHT RT

Other Intervention Name(s)

Moderate Hypofractionation Radiation Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of Early Prostate Tumor Response (EPTR)

Description

Prostate Tumor Pathologic Complete Response (PathCR measured using ultrasound guided systematic prostate biopsy) and or early biochemical response at 9 months post-RT.

Time Frame

Up to 3 years

Secondary Outcome Measure Information:

Title

Correlation between EPTR and Changes in serial post-RT MRIs

Description

Time Frame

3 months post-RT, 9-months post-RT, within 3 months of 2-2.5 post-treatment biopsy

Title

Number of participants experiencing treatment related adverse events

Description

Number of participants experiencing acute and late toxicity will be evaluated by treating physicians

Time Frame

Up to 2 years

Title

Health-Related Quality of Life Scores: EPIC SF-12

Description

Time Frame

Up to 5.25 years (post-treatment)

Title

Health-Related Quality of Life Scores: MAX-PC

Description

Time Frame

Up to 5.25 years (post-treatment)

Title

Health-Related Quality of Life Scores: IPSS

Description

Time Frame

Up to 5.25 years (post-treatment)

Title

Change in gene/biomarker expression

Description

Change in gene/biomarker expression in different MP-MRI tumor regions assessed from prostate biopsy samples.

Time Frame

Baseline, Up to 5.25 years (post-treatment)

Title

Rate of participant response

Description

Time Frame

Up to 5.25 years (post-treatment)

Title

Change in CTC Levels

Description

Circulating Tumor Cell (CTC) levels evaluated from peripheral blood samples.

Time Frame

Baseline (pre-treatment), Up to 2 years (post-treatment)

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Eligibility Criteria: A. Biopsy confirmed adenocarcinoma (including ductal) of the prostate. B. T1-T3 disease based on digital rectal exam. C. No evidence of metastasis by any clinical criteria or available radiographic tests (N0M0 by clinical or imaging criteria). D. Gleason score 6-10. E. Androgen deprivation therapy (ADT) is at the discretion of the treating physician; but, must be decided (none, short-term or long-term as counted from the luteinizing hormone-releasing hormone (LHRH) agonist or antagonist injection) prior to enrollment. An anti-androgen (e.g., bicalutamide at 50 mg per day po) is recommended to start prior to LHRH agonist injection (not recommended for LHRH antagonist injection) and is recommended to not be administered for more than 4 months. If ADT is planned, the following restrictions apply: i. It may be initiated no more than 3 months prior to the signing of consent ii. It must be started prior to the start of radiotherapy and iii. The total length planned must be ≤ 30 months F. Prostate-specific Antigen (PSA) ≤ 100 ng/mL within (+/-) 4 months of signing of consent. If PSA was above 100 and drops to ≤ 100 with antibiotics, this is acceptable for enrollment. G. Subjects with T3 disease based on digital rectal exam (DRE), Gleason 8-10 or a PSA of >15 ng/ml, should have a bone scan within (+/-) 4 months of signing of consent that is without evidence of metastasis. A questionable bone scan is acceptable if additional imaging studies (e.g., plain x-rays, CT, or MRI) do not confirm for metastasis. H. Suspicious peripheral zone or central gland lesion on MP-MRI i. Peripheral zone: Distinct lesion on dynamic contrast-enhanced MRI (DCE-MRI) with early enhancement and later washout (Note: contrast not required for enrollment), and/or distinct lesion on the ADC map (Value <1000). ii. Central gland: A suspicious central gland lesion on MP-MRI must have a distinct lesion on the apparent diffusion coefficient (ADC) map (Value <1000) I. No previous pelvic radiotherapy. J. No previous history of radical/total prostatectomy (suprapubic prostatectomy is acceptable). K. No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 5 years then the patient is eligible. L. Ability to understand and the willingness to sign a written informed consent document. M. Zubrod performance status ≤ 2. (Karnofsky or Eastern Cooperative Oncology Group (ECOG) performance status may be used to estimate Zubrod). N. Willingness to fill out quality of life/psychosocial forms. O. Age ≥ 35 and ≤ 85 years at signing of consent.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pavel Noa Hechavarria

Phone

305-243-1036

pavel.noa@med.miami.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alan Pollack, MD, PhD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pavel Noa Hechavarria

Phone

305-243-1036

pavel.noa@med.miami.edu

First Name & Middle Initial & Last Name & Degree

Alan Pollack, MD

First Name & Middle Initial & Last Name & Degree

Matthew Abramowitz, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Some data after completion of the trial and publication of the primary endpoint. Additional data after publication of the secondary endpoints.

Learn more about this trial

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

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