NCT01411345Active, not recruiting
MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
A Phase II Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 4 Aug 2011
- Start date
- 12 Jul 2012
- Primary completion date
- 13 Feb 2024
- Lead sponsor
- University of Miami
- Diseases
- Prostate cancer
- NCT number
- NCT01411345
What you commit to
- Study type: Interventional
- Participants enrolled: 37
- From 12 Jul 2012 to the primary completion date, 13 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Who the study is looking for
- 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.
Age in the registry: 35 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.