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

NCT01411345 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: 20101056
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor regions (when applicable).
3. 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. 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).

Conditions

Prostate Cancer; Prostate Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• PSA Response Rate

  Prostate-Specific Antigen (PSA) response rate is defined as the percentage of study patients with PSA less than 0.1 ng/mL at 21 months after completion of study treatment.

  Up to 23 months

Secondary Outcomes (9)

• Incidence of Treatment-Emergent Toxicity

  Up to 8 months

• Health-Related Quality of Life Scores: EPIC SF-12

  Up to 65 months

• Health-Related Quality of Life Scores: MAX-PC

  Up to 65 months

• Health-Related Quality of Life Scores: IPSS

  Up to 65 months

• Biochemical and Clinical Failure

  Up to 65 months

Study Arms (3)

Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT)

OTHER

Phase 3 total dose of 68 Gy will be delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes. this arm is closed

Radiation: Standard Salvage Radiation Treatment (SSRT)

Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT)

EXPERIMENTAL

Phase 3 Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3). this arm was continues as single arm phase 2

Radiation: Mapped Tumor Salvage RT (MTSRT)

Phase 2: Mapped Tumor Salvage RT (MTSRT)

EXPERIMENTAL

Phase 2 Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).

Radiation: Mapped Tumor Salvage RT (MTSRT)

Interventions

Mapped Tumor Salvage RT (MTSRT) RADIATION

Dose escalation to the imaging or Dynamic Contrast Enhanced MRI (DCE-MRI)-defined dominant region(s) by dose painting at 2.25 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 68 Gy. The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in 2.0 Gy fractions.

Phase 2: Mapped Tumor Salvage RT (MTSRT); Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT)

Standard Salvage Radiation Treatment (SSRT) RADIATION

A total dose of 68 Gy delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.

Also known as: SSRT

Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT)

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Matthew Abramowitz MD
• Organization: University of Miami

mabramowitz@med.miami.edu

305-243-4200

Study Officials

• Matthew C Abramowitz, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 8, 2011
• Study Start: July 12, 2012
• Primary Completion: February 13, 2024
• Study Completion (Estimated): February 13, 2028
• Last Updated: May 5, 2026
• Results First Posted: April 8, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)