Prostate CancerMAPSNCT01411345
MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
A study testing Standard Salvage Radiation Treatment (SSRT) and Mapped Tumor Salvage RT (MTSRT) in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma
- What is being tested?
- Standard Salvage Radiation Treatment (SSRT) and Mapped Tumor Salvage RT (MTSRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2012to 13 Feb 2028
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
- 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.
- Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor regions (when applicable).
- 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that are related to an adverse treatment outcome.
- 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).
Read the 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.
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Being tested
- Standard Salvage Radiation Treatment (SSRT), Mapped Tumor Salvage RT (MTSRT)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Salvage Radiation Treatment (SSRT)Radiation
Also called SSRT
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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). Receives: Radiation: Mapped Tumor Salvage RT (MTSRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 23 months
Secondary outcomes (9)
Incidence of Treatment-Emergent Toxicity
Incidence of treatment-emergent toxicity in study participants. Toxicity is defined as adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs)Acute toxicity is defined as toxicity occurring during treatment and within three months of completing treatment. Late toxicity is toxicity occurring more than three months after treatment completion. Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Measured: Up to 8 months
Health-Related Quality of Life Scores: EPIC SF-12
Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Measured: Up to 65 months
Health-Related Quality of Life Scores: MAX-PC
Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
Measured: Up to 65 months
Health-Related Quality of Life Scores: IPSS
Health-related quality of life (HRQOL) will be measured using the International Prostate Symptom Score (IPSS) to evaluate patient urinary function and quality of life. There are 7 questions related to urinary function. Responses are on a scale from 0 ("not at all") to 5 ("almost always"), with higher scores indicating higher levels of urinary dysfunction. There is 1 quality of life question related to urinary symptoms. Responses are on a scale from 0 ("delighted") to 6 ("terrible").
Measured: Up to 65 months
Biochemical and Clinical Failure
The cumulative incidence of biochemical or clinical failure allowing for competing risk as needed. Clinical failure is defined as at least a 25% increase in the size of the tumor relative to the smallest volume recorded, or new extension of tumor beyond the capsule, or re-extension of tumor beyond the capsule after initial regression, or urinary obstructive symptoms with carcinoma found at transurethral resection of the prostate (TURP). Biochemical failure is defined as PSA ≥ nadir + 2 ng/mL.
Measured: Up to 65 months
Failure-free Survival (FFS)
Rate of failure-free survival in study participants. Failure-free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status.
Measured: Up to 65 months
Overall Survival (OS)
Rate of overall survival in study participants. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.
Measured: Up to 65 months
Measurement of Tissue Biomarker Expression
The distribution and degree of expression of tissue biomarkers by ultrasound-directed biopsies for patients who choose to undergo the optional biopsies. Quantification of the amount of the biomarker specific immunohistochemical staining in the area of tumor.
Measured: Up to 65 months
Incidence and Relationship of Circulating DNA and Tumor Cells to Tissue Biomarkers
To determine the incidence and relationship of circulating DNA and tumor cells to tissue biomarkers and initial complete biochemical response.
Measured: Up to 65 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study start12 Jul 2012
- Primary completion13 Feb 2024
- Study completion13 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Abramowitz, MD, University of Miami
- Investigators
- Matthew C Abramowitz, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411345
- Sponsor's protocol ID
- 20101056
- Acronym
- MAPS
- Status last verified
- Mar 2026
- First submitted
- 4 Aug 2011
- Last updated
- 5 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
- ClinicalTrials.gov ID
- NCT01411345
- Acronym / sponsor ID
- MAPS / 20101056
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 Jul 2012 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2028 (estimated)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Posted 8 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor regions (when applicable).
- 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that are related to an adverse treatment outcome.
- 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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT) | Other | Radiation: Standard Salvage Radiation Treatment (SSRT)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 |
| Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT) | Experimental | Radiation: Mapped Tumor Salvage RT (MTSRT)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 |
| Phase 2: Mapped Tumor Salvage RT (MTSRT) | Experimental | Radiation: Mapped Tumor Salvage RT (MTSRT)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). |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Salvage Radiation Treatment (SSRT)Also: SSRTA 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. | Radiation | Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT) |
| Mapped Tumor Salvage RT (MTSRT)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. | Radiation | Phase 2: Mapped Tumor Salvage RT (MTSRT), Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT) |
Primary outcome
PSA Response Rate
Time frame: Up to 23 months
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.
9 secondary outcomes
Incidence of Treatment-Emergent Toxicity
Time frame: Up to 8 months
Health-Related Quality of Life Scores: EPIC SF-12
Time frame: Up to 65 months
Health-Related Quality of Life Scores: MAX-PC
Time frame: Up to 65 months
Health-Related Quality of Life Scores: IPSS
Time frame: Up to 65 months
Biochemical and Clinical Failure
Time frame: Up to 65 months
Failure-free Survival (FFS)
Time frame: Up to 65 months
Overall Survival (OS)
Time frame: Up to 65 months
Measurement of Tissue Biomarker Expression
Time frame: Up to 65 months
Incidence and Relationship of Circulating DNA and Tumor Cells to Tissue Biomarkers
Time frame: Up to 65 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew C Abramowitz, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Salvage Radiation Treatment (SSRT) and Mapped Tumor Salvage RT (MTSRT) in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSA Response Rate (time frame: Up to 23 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.