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


Phase 3
35 Years
85 Years
Open (Enrolling)
Male
Prostate Cancer, Prostate Adenocarcinoma

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Trial Information

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


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 ≤ 8 weeks 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 8 weeks 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of Radiation boost to the MRI Lesion

Outcome Description:

The primary objective is to determine the effect of radiation boost to the MRI lesion on initial complete biochemical response.

Outcome Time Frame:

5.25 years

Safety Issue:

No

Principal Investigator

Matthew C Abramowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20101056

NCT ID:

NCT01411345

Start Date:

June 2011

Completion Date:

June 2017

Related Keywords:

  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136