Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial (MAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01411345
Recruitment Status : Recruiting
First Posted : August 8, 2011
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Matthew Abramowitz, MD, University of Miami

Brief Summary:
  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 (when applicable).
  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 (compared to those pts who were treated on standard arm prior to its closure).

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Adenocarcinoma Radiation: Standard Salvage Radiation Treatment (SSRT) Radiation: Mapped Tumor Salvage RT (MTSRT) Phase 2 Phase 3

Detailed Description:
Phase 3 arms I (SSRT) and II (MTSRT) were closed. Study recruitment was suspended until re-opening as a single-arm Phase 2 (MTSRT) study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
Actual Study Start Date : July 12, 2012
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT)

Phase 3 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.

this arm is closed

Radiation: Standard Salvage Radiation Treatment (SSRT)
A total dose of 68 Gy 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

Experimental: Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT)

Phase 3 Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).

this arm was continues as single arm phase 2

Radiation: Mapped Tumor Salvage RT (MTSRT)
Dose escalation to the imaging or 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.

Experimental: Phase 2: Mapped Tumor Salvage RT (MTSRT)
Phase 2 Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).
Radiation: Mapped Tumor Salvage RT (MTSRT)
Dose escalation to the imaging or 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.




Primary Outcome Measures :
  1. PSA Response Rate [ Time Frame: 21 months Post-Completion of Protocol Therapy ]
    PSA response rate is defined as the proportion of study patients with PSA less than 0.1 ng/mL at 21 months after completion of study treatment.


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Toxicity [ Time Frame: Up to 3 months post-completion of therapy ]
    Incidence of treatment-emergent toxicity in study participants. Toxicity is defined as adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs)Acute toxicity is defined as toxicity occurring during treatment and within three months of completing treatment. Late toxicity is toxicity occurring more than three months after treatment completion. Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

  2. Health-Related Quality of Life Scores: EPIC SF-12 [ Time Frame: Up to 5.25 years post-Protocol Therapy ]
    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.

  3. Health-Related Quality of Life Scores: MAX-PC [ Time Frame: Up to 5.25 years post-Protocol Therapy ]
    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.

  4. Health-Related Quality of Life Scores: IPSS [ Time Frame: Up to 5.25 years post-Protocol Therapy ]
    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").

  5. Biochemical and Clinical Failure [ Time Frame: Up to 5.25 years post-Protocol Therapy ]
    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.

  6. Failure-free Survival (FFS) [ Time Frame: Up to 5.25 years post-Protocol Therapy ]
    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.

  7. Overall survival (OS) [ Time Frame: Up to 5.25 years post-Protocol Therapy ]
    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.

  8. Measurement of Tissue Biomarker Expression [ Time Frame: Up to 5.25 years post-Protocol Therapy ]
    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.

  9. Incidence and relationship of circulating DNA and tumor cells to tissue biomarkers [ Time Frame: Up to 5.25 years post-Protocol Therapy ]
    To determine the incidence and relationship of circulating DNA and tumor cells to tissue biomarkers and initial complete biochemical response.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
  3. Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
  4. Imaging detectable lesion or lesions in prostate bed or regional lymph node (LN). Each lesion should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to protocol entry or enrollment.
  5. No evidence of metastatic (distant) disease (pelvic nodes are allowed up to common iliac).
  6. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment.
  7. No previous pelvic radiotherapy.
  8. Serum total testosterone taken within 3 months prior to enrollment.
  9. 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 ≥ 3 years then the patient is eligible.
  10. Ability to understand and the willingness to sign a written informed consent document.
  11. Zubrod performance status < 2.
  12. Patients must agree to fill out quality of life/psychosocial questionnaires.
  13. 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).


Information from the National Library of Medicine

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): NCT01411345


Contacts
Layout table for location contacts
Contact: Pavel Noa Hechevarria 305-243-1036 pavel.noa@med.miami.edu

Locations
Layout table for location information
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Pavel N Hechevarria    305-243-1036    pavel.noa@med.miami.edu   
Principal Investigator: Alan Pollack, MD, PhD         
Principal Investigator: Matthew Abramowitz, MD         
Sponsors and Collaborators
University of Miami
Investigators
Layout table for investigator information
Principal Investigator: Matthew C Abramowitz, MD University of Miami
Layout table for additonal information
Responsible Party: Matthew Abramowitz, MD, Assistant Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT01411345    
Other Study ID Numbers: 20101056
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type