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

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer, Prostate Adenocarcinoma

In brief

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).

Key facts

Study ID

NCT01411345

Run by

University of Miami

People needed

37

Starts

2012-07-12

Expected to finish

2028-02-13

Last updated by the study team

2026-05-05

Who can join

Age: 35 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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