A Phase III Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Miami
Sponsor:
Information provided by (Responsible Party):
Matthew Abramowitz, University of Miami
ClinicalTrials.gov Identifier:
NCT01411345
First received: August 4, 2011
Last updated: August 13, 2014
Last verified: August 2014
  Purpose
  1. The investigators hypothesize that increasing radiation dose to the functional MRI-defined lesion in the prostate bed will result in an improved initial complete response (reduction in PSA to < 0.1 ng/mL), which is related to long-term outcome biochemically.
  2. Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor regions.
  3. 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that are related to an adverse treatment outcome.
  4. Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose.

Condition Intervention Phase
Prostate Cancer
Prostate Adenocarcinoma
Radiation: Standard Salvage Radiation Treatment (SSRT)
Radiation: Mapped Tumor Salvage RT (MTSRT)
Procedure: DCE-MRI of Pelvis/Prostate
Procedure: Ultrasound Prostate Bed Biopsy
Procedure: Urine Sample Collection
Procedure: Blood Sample Collection
Behavioral: EPIC SF-12 Questionnaire
Behavioral: MAC-PC Questionnaire
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Effect of Radiation boost to the MRI Lesion [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
    The primary objective is to determine the effect of radiation boost to the MRI lesion on initial complete biochemical response.


Secondary Outcome Measures:
  • Impact of SRT boost to MRI-identified lesion on toxicity and quality of life [ Time Frame: 5.25 years ] [ Designated as safety issue: Yes ]
    To determine the impact of SRT boost to the MRI-identified lesion on toxicity, health-related quality of life (HRQOL), prostate cancer-specific anxiety, and prostate cancer-specific QOL.

  • Biochemical and clinical failure; failure-free survival, overall survival [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
    To evaluate biochemical and clinical failure, failure-free survival, and overall survival.

  • Biomarker expression [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
    To determine the distribution and degree of expression of tissue biomarkers by US-directed biopsies.

  • Incidence and relationship of circular DNA and tumor cells to tissue biomarkers [ Time Frame: 5.25 years ] [ Designated as safety issue: No ]
    To determine the incidence and relationship of circulating DNA and tumor cells to tissue biomarkers and initial complete biochemical response.


Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I: SSRT
Standard Salvage Radiation Treatment (SSRT)
Radiation: Standard Salvage Radiation Treatment (SSRT)
Patients will receive 68 Gy in 2 Gy fractions to the prostate bed clinical target volume (CTV).
Procedure: DCE-MRI of Pelvis/Prostate
Dynamic Contrast Enhanced-MRI of the Pelvis/Prostate prior to radiation therapy, 3 months, 9 months and 2 years post-radiation therapy
Procedure: Ultrasound Prostate Bed Biopsy
Optional Ultrasound Prostate Bed Biopsy prior to radiation therapy; 2 - 2.5 years post radiation therapy.
Procedure: Urine Sample Collection
Urine sample collection prior to radiation therapy, during last week of radiation therapy, 3 months and 2 years post-radiation therapy.
Procedure: Blood Sample Collection
Plasma and Serum sample collection prior to radiation therapy, during last week of radiation therapy, 3 months and 2 years post-radiation therapy.
Behavioral: EPIC SF-12 Questionnaire
Expanded Prostate Cancer Index Composite-Sf12 (EPIC SF12) quality of life questionnaire prior to radiation therapy, during last week of radiation therapy, 6 weeks, 3 months, 9 months, 15 months and yearly to 5.25. years post-radiation therapy.
Behavioral: MAC-PC Questionnaire
Memory Anxiety Scale for Prostate Cancer patients (MAX-PC) questionnaire prior to radiation therapy, during last week of radiation therapy, 6 weeks, 3 months, 9 months, 15 months and yearly to 5.25. years post-radiation therapy.
Active Comparator: Arm II: MTSRT
Mapped Tumor Salvage RT (MTSRT)
Radiation: Mapped Tumor Salvage RT (MTSRT)
Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the GTV defined by DCE-MRI will receive 2.2 Gy per day for a total of 74.8 Gy (biological equivalent to 77.5 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).
Procedure: DCE-MRI of Pelvis/Prostate
Dynamic Contrast Enhanced-MRI of the Pelvis/Prostate prior to radiation therapy, 3 months, 9 months and 2 years post-radiation therapy
Procedure: Ultrasound Prostate Bed Biopsy
Optional Ultrasound Prostate Bed Biopsy prior to radiation therapy; 2 - 2.5 years post radiation therapy.
Procedure: Urine Sample Collection
Urine sample collection prior to radiation therapy, during last week of radiation therapy, 3 months and 2 years post-radiation therapy.
Procedure: Blood Sample Collection
Plasma and Serum sample collection prior to radiation therapy, during last week of radiation therapy, 3 months and 2 years post-radiation therapy.
Behavioral: EPIC SF-12 Questionnaire
Expanded Prostate Cancer Index Composite-Sf12 (EPIC SF12) quality of life questionnaire prior to radiation therapy, during last week of radiation therapy, 6 weeks, 3 months, 9 months, 15 months and yearly to 5.25. years post-radiation therapy.
Behavioral: MAC-PC Questionnaire
Memory Anxiety Scale for Prostate Cancer patients (MAX-PC) questionnaire prior to radiation therapy, during last week of radiation therapy, 6 weeks, 3 months, 9 months, 15 months and yearly to 5.25. years post-radiation therapy.

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up to 3.0 ng/mL within 8 weeks prior to enrollment.
  • Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
  • Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
  • MRI detectable lesion in prostate bed. DCE-MRI enhancing lesion in the prostate bed should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to enrollment.
  • No evidence of metastatic (regional or distant) disease on the pelvic MRI.
  • Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to enrollment.
  • No previous pelvic radiotherapy.
  • Prior androgen deprivation therapy is permitted as long as it was >6 months previous to enrollment and was ≤7 months in duration.
  • Serum total testosterone is within 40% of normal assay limits, taken within 4 months prior to enrollment.
  • BUN and creatinine is within 40% of normal assay limits, taken within 3 months prior to enrollment.
  • 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.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Zubrod performance status <2.
  • Patients must agree to fill out quality of life/psychosocial questionnaires.
  • Age ≥35 and ≤85 years.

Exclusion Criteria:

  • Prostate cancer patients with a PSA after prostatectomy of less than 0.1 ng/mL or greater than 3.0 ng/mL.
  • Less than 3 months since prostatectomy.
  • Unable to obtain a 3T MRI of the pelvis and prostate with contrast prior to enrollment.
  • No detectable MRI lesion in prostate bed.
  • Patients with detectable DCE-MRI lesion which are less than 0.4 cc and greater than 6 cc
  • Evidence of metastatic (regional or distant) disease on the pelvic MRI.
  • Positive bone scan 4 months prior to enrollment.
  • Previous pelvic radiotherapy.
  • Prior androgen deprivation therapy is not permitted if it was within 6 months previous to enrollment and/or was > 7 months in duration.
  • Serum total testosterone is not within 40% of normal assay limits, taken within 4 months prior to enrollment.
  • BUN and creatinine is not within 40% of normal assay limits, taken within 8 weeks prior to enrollment.
  • Concurrent, active malignancy, which is not 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 not eligible.
  • Inability to understand and unwilling to sign a written informed consent document.
  • Zubrod performance status ≥ 2.
  • Not willing to fill out quality of life/psychosocial questionnaires.
  • Age < 35 and > 85 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411345

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Matthew C Abramowitz, MD    305-243-4200    mabramowitz@med.miami.edu   
Contact: University of Miami Sylvester Comprehensive Cancer Center    866-574-5124    sylvester@emergingmed.com   
Sub-Investigator: Alan Pollack, MD, PhD         
Sub-Investigator: Victor Casillas, MD         
Sub-Investigator: Ram Datar, MD         
Sub-Investigator: Jennifer Hu, PhD         
Sub-Investigator: Charles Lynne, MD         
Sub-Investigator: Murughesan Manoharan, MD         
Sub-Investigator: Arnold Markoe, MD         
Sub-Investigator: Lorraine Portelance, MD         
Sub-Investigator: Michael Samuels, MD         
Sub-Investigator: Rakesh Singal, MD         
Sub-Investigator: Radka Stoyanova, PhD         
Sub-Investigator: Aaron Wolfson, MD         
Sub-Investigator: Adrian Ishkanian, MD         
Sub-Investigator: Merce Jorda, MD         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Matthew C Abramowitz, MD University of Miami
  More Information

No publications provided

Responsible Party: Matthew Abramowitz, Assistant Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT01411345     History of Changes
Other Study ID Numbers: 20101056
Study First Received: August 4, 2011
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
Prostate Cancer
Prostate Adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 21, 2014