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Proton Beam Therapy

Dose-Escalated Salvage Radiotherapy for Prostate Cancer (MAPS Trial)

Q: Does this research project allow for young adults as participants?

The requirements to enroll in this particular trial are that patients must be aged 35 to 85. There are 61 clinical trials that cater to patients under 18 and 1634 trials for people over the age of 65.

Q: Are there any patients who can still participate in this research?

That is correct. The table on clinicaltrials.gov implies that this study is currently looking for participants. This trial was originally posted on July 12th, 2012 and the most recent update was December 1st, 2021. They are admitting 80 patients in total, from a single location.

Q: What are the requirements for eligible participants in this research project?

This study is searching for 80 individuals aged between 35 and 85 that have been diagnosed with <a href="https://www.withpower.com/clinical-trials/prostate-cancer">prostate cancer</a>. In addition to meeting the age criteria, patients must also meet the following requirements: no evidence of metastatic disease (with the exception of pelvic nodes), no active malignancy, a PSA score of 0.1-4.0 within 3 months of enrollment, a negative bone scan (if deemed necessary by a physician), no previous pelvic radiotherapy, and the ability to understand and sign a written informed consent document.

N/A

Waitlist Available

Led By Matthew C Abramowitz, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5.25 years post-protocol therapy

Awards & highlights

MAPS Trial Summary

This trial is testing whether increasing the radiation dose to the area of the prostate cancer defined by an MRI will improve the initial response to treatment (as measured by a reduction in prostate-specific antigen (PSA) levels) and whether this is related to long-term outcome.

Who is the study for?

Men aged 35-85 with prostate cancer, who've had a prostatectomy and have PSA levels between 0.1 to 4.0 ng/mL within the last three months. They should not have distant metastatic disease or previous pelvic radiotherapy, must be at least three months post-surgery, and able to sign consent.Check my eligibility

What is being tested?

The MAPS Trial is testing if increasing radiation doses directly to MRI-detected lesions in the prostate bed can improve initial response rates (lowering PSA to <0.1 ng/mL) compared to standard salvage radiation treatment.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions associated with radiation therapy such as fatigue, skin irritation in the treated area, urinary issues, bowel changes, and erectile dysfunction.

MAPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a detectable tumor in my prostate or nearby lymph nodes, measured recently.

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My cancer has not spread far, except possibly to pelvic nodes.

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I am between 35 and 85 years old.

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I have not had radiation therapy to my pelvic area.

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I can carry out all my self-care but cannot work.

MAPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5.25 years post-protocol therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5.25 years post-protocol therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5.25 years post-protocol therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PSA Response Rate

Secondary outcome measures

Biochemical and Clinical Failure

Failure-free Survival (FFS)

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

+6 more

MAPS Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT)Experimental Treatment1 Intervention

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

Group II: Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT)Experimental Treatment1 Intervention

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

Group III: Phase 2: Mapped Tumor Salvage RT (MTSRT)Experimental Treatment1 Intervention

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).

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

898 Previous Clinical Trials

409,614 Total Patients Enrolled

16 Trials studying Prostate Cancer

3,850 Patients Enrolled for Prostate Cancer

Matthew C Abramowitz, MDPrincipal InvestigatorUniversity of Miami

1 Previous Clinical Trials

5 Total Patients Enrolled

Media Library

Mapped Tumor Salvage RT (MTSRT) (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01411345 — N/A

Prostate Cancer Research Study Groups: Phase 2: Mapped Tumor Salvage RT (MTSRT), Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT), Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT)

Prostate Cancer Clinical Trial 2023: Mapped Tumor Salvage RT (MTSRT) Highlights & Side Effects. Trial Name: NCT01411345 — N/A

Mapped Tumor Salvage RT (MTSRT) (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01411345 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project allow for young adults as participants?

"The requirements to enroll in this particular trial are that patients must be aged 35 to 85. There are 61 clinical trials that cater to patients under 18 and 1634 trials for people over the age of 65."

Answered by AI

Are there any patients who can still participate in this research?

"That is correct. The table on clinicaltrials.gov implies that this study is currently looking for participants. This trial was originally posted on July 12th, 2012 and the most recent update was December 1st, 2021. They are admitting 80 patients in total, from a single location."

Answered by AI

What are the requirements for eligible participants in this research project?

"This study is searching for 80 individuals aged between 35 and 85 that have been diagnosed with prostate cancer. In addition to meeting the age criteria, patients must also meet the following requirements: no evidence of metastatic disease (with the exception of pelvic nodes), no active malignancy, a PSA score of 0.1-4.0 within 3 months of enrollment, a negative bone scan (if deemed necessary by a physician), no previous pelvic radiotherapy, and the ability to understand and sign a written informed consent document."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Matthew Abramowitz, MD 2012. "MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01411345.

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