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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 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: November 14, 2016
Last verified: November 2016
  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 prostate-specific antigen (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)
Behavioral: Expanded Prostate Cancer Index Composite-SF12
Behavioral: Memory Anxiety Scale for Prostate Cancer patients
Behavioral: International Prostate Symptom Score (IPSS)
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:
  • Rate of PSA Response to Protocol Therapy [ Time Frame: 21 months Post-Completion of Protocol Therapy ] [ 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. Rate of PSA response is defined as the proportion of study patients with PSA < 0.1 ng/mL at 21 months after completion of study treatment.


Secondary Outcome Measures:
  • Rate of Acute and Late Toxicity [ Time Frame: Up to 5.25 years post-Protocol Therapy ] [ Designated as safety issue: Yes ]

    The impact of protocol therapy on toxicity in study participants:

    • Acute toxicity: Toxicity occurring during treatment and within three months of completing treatment.
    • Late toxicity: Toxicity occurring more than three months after treatment completion.

  • Impact of Protocol Therapy on Study Participant Health-Related Quality of Life (HRQOL) [ Time Frame: Up to 5.25 years post-Protocol Therapy ] [ Designated as safety issue: No ]
    The impact of protocol therapy on study participant health-related quality of life (HRQOL), will be measured and scored via the Expanded Prostate Cancer Index Composite Questionnaire-SF12 quality of life questionnaire.

  • Impact of Protocol Therapy on Study Participant Prostate Cancer-Specific Anxiety [ Time Frame: Up to 5.25 years post-Protocol Therapy ] [ Designated as safety issue: No ]
    The impact of protocol therapy on study participant prostate cancer-specific anxiety will be measured and scored via the Memorial Anxiety Scale for Prostate Cancer patients (MAX-PC) quality of life questionnaire.

  • Impact of Protocol Therapy on Study Participant Prostate Cancer-specific Quality of Life (QOL). [ Time Frame: Up to 5.25 years post-Protocol Therapy ] [ Designated as safety issue: No ]
    The impact of protocol therapy on study participant prostate cancer-specific QOL will be measured and scored via the International Prostate Symptom Score (IPSS) quality of life questionnaire.

  • Rate of Biochemical and Clinical Failure [ Time Frame: Up to 5.25 years post-Protocol Therapy ] [ Designated as safety issue: No ]
    The cumulative incidence of biochemical or clinical failure allowing for competing risk as needed. Clinical failure is defined as at least a 25% increase in the size of the tumor relative to the smallest volume recorded, or new extension of tumor beyond the capsule, or re-extension of tumor beyond the capsule after initial regression, or urinary obstructive symptoms with carcinoma found at transurethral resection of the prostate (TURP). Biochemical failure is defined as PSA ≥ nadir + 2 ng/mL.

  • Rate of Failure-free Survival (FFS) [ Time Frame: Up to 5.25 years post-Protocol Therapy ] [ Designated as safety issue: No ]
    Rate of failure-free survival in study participants. Failure-free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status.

  • Rate of Overall survival (OS) [ Time Frame: Up to 5.25 years post-Protocol Therapy ] [ Designated as safety issue: No ]
    Rate of overall survival in study participants. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.

  • Measurement of Tissue Biomarker Expression [ Time Frame: Up to 5.25 years post-Protocol Therapy ] [ Designated as safety issue: No ]
    The distribution and degree of expression of tissue biomarkers by ultrasound-directed biopsies for patients who choose to undergo the optional biopsies. Quantification of the amount of the biomarker specific immunohistochemical staining in the area of tumor.

  • Incidence and relationship of circulating DNA and tumor cells to tissue biomarkers [ Time Frame: Up to 5.25 years post-Protocol Therapy ] [ 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 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I: SSRT

Standard Salvage Radiation Treatment (SSRT)

  • SSRT: 68 Gy in 34 fractions (2.0 Gy) Homogenous Plan.
  • Expanded Prostate Cancer Index Composite-SF12 (EPIC SF12) quality of life questionnaire;
  • Memory Anxiety Scale for Prostate Cancer patients (MAX-PC) quality of life questionnaire;
  • International Prostate Symptom Score (IPSS) quality of life questionnaire;
  • OPTIONAL: Ultrasound guided biopsy, blood and urine sample collection for correlative studies
Radiation: Standard Salvage Radiation Treatment (SSRT)
A total dose of 68 Gy will be delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
Other Name: SSRT
Behavioral: Expanded Prostate Cancer Index Composite-SF12
Expanded Prostate Cancer Index Composite-Sf12 (EPIC SF12) quality of life questionnaire to be administered to study participants at protocol-defined intervals.
Other Name: EPIC SF-12
Behavioral: Memory Anxiety Scale for Prostate Cancer patients
Memory Anxiety Scale for Prostate Cancer patients (MAX-PC) quality of life questionnaire to be administered to study participants at protocol-defined intervals.
Other Name: MAX-PC
Behavioral: International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS) quality of life questionnaire to be administered to study participants at protocol-defined intervals.
Other Name: IPSS
Active Comparator: Arm II: MTSRT

Mapped Tumor Salvage RT (MTSRT):

  • MTSRT: 68 Gy in 34 fractions plus MT Boost to gross tumor volume (GTV) 76.5 Gy (2.25 Gy/fx) equivalent to 80 Gy in 2.0 Gy fractions.
  • Expanded Prostate Cancer Index Composite-SF12 (EPIC SF12) quality of life questionnaire;
  • Memory Anxiety Scale for Prostate Cancer patients (MAX-PC) quality of life questionnaire;
  • International Prostate Symptom Score (IPSS) quality of life questionnaire;
  • OPTIONAL: Ultrasound guided biopsy, blood and urine sample collection for correlative studies
Radiation: Mapped Tumor Salvage RT (MTSRT)
Dose escalation to the Dynamic Contrast Enhanced MRI (DCE-MRI)-defined dominant region(s) by dose painting at 2.25 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 68 Gy. The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in 2.0 Gy fractions.
Behavioral: Expanded Prostate Cancer Index Composite-SF12
Expanded Prostate Cancer Index Composite-Sf12 (EPIC SF12) quality of life questionnaire to be administered to study participants at protocol-defined intervals.
Other Name: EPIC SF-12
Behavioral: Memory Anxiety Scale for Prostate Cancer patients
Memory Anxiety Scale for Prostate Cancer patients (MAX-PC) quality of life questionnaire to be administered to study participants at protocol-defined intervals.
Other Name: MAX-PC
Behavioral: International Prostate Symptom Score (IPSS)
International Prostate Symptom Score (IPSS) quality of life questionnaire to be administered to study participants at protocol-defined intervals.
Other Name: IPSS

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A. Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up to 4.0 ng/mL within 3 months prior to enrollment.
  • B. Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
  • C. Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
  • D. 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.
  • E. No evidence of metastatic (regional or distant) disease on the pelvic MRI.
  • F. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to enrollment.
  • G. No previous pelvic radiotherapy.
  • H. Serum total testosterone is within 40% of normal assay limits, taken within 34 months prior to enrollment. Patient who have been started on androgen deprivation therapy (ADT) prior to signing consent are not required to have serum testosterone with the range outlined; but, should have a serum testosterone level recorded prior to enrollment.
  • I. 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.
  • J. Ability to understand and the willingness to sign a written informed consent document.
  • K. Zubrod performance status < 2.
  • L. Patients must agree to fill out quality of life/psychosocial questionnaires.
  • M. Age ≥ 35 and ≤ 85 years.

Exclusion Criteria:

  • A. Prior androgen deprivation therapy is not permitted if it was within 6 months previous to signing consent form. (NOTE: Therapy given as part of the planned course of radiation is allowed).
  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   
Principal Investigator: Alan Pollack, MD, PhD         
Principal Investigator: Matthew Abramowitz, MD         
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Matthew C Abramowitz, MD University of Miami
  More Information

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: November 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Miami:
Prostate Cancer
Prostate Adenocarcinoma

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

ClinicalTrials.gov processed this record on December 06, 2016