Active — Not RecruitingNot Applicable

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

United States37 participantsStarted 2012-07-12

Plain-language 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).

Who can participate

Age range35 Years – 85 Years

SexMALE

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Inclusion criteria

✓. 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.

What they're measuring

PSA Response Rate

Timeframe: Up to 23 months

Trial details

NCT IDNCT01411345

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-13

Results submitted2025-02-11

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