Status:
ACTIVE_NOT_RECRUITING
MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
Lead Sponsor:
University of Miami
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
35-85 years
Phase:
NA
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-spe...
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.
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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.
- No evidence of metastatic (distant) disease (pelvic nodes are allowed up to common iliac).
- Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment.
- No previous pelvic radiotherapy.
- Serum total testosterone 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 ≥ 3 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
- 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).
Key Trial Info
Start Date :
July 12 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2028
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01411345
Start Date
July 12 2012
End Date
February 13 2028
Last Update
April 8 2025
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136