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Proton Beam Therapy

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

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

No Placebo-Only Group

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.

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.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PSA Response Rate

Secondary study objectives

Biochemical and Clinical Failure

Failure-free Survival (FFS)

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

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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