Clinical trial NCT01411345: MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
Official title: A Phase II Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 37
Sex: MALE
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
3. Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
4. 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.
5. No evidence of metastatic (distant) disease (pelvic nodes are allowed up to common iliac).
6. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment.
7. No previous pelvic radiotherapy.
8. Serum total testosterone taken within 3 months prior to enrollment.
9. 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.
10. Ability to understand and the willingness to sign a written informed consent document.
11. Zubrod performance status \< 2.
12. Patients must agree to fill out quality of life/psychosocial questionnaires.
13. Age ≥ 35 and ≤ 85 years.

Exclusion Criteria:

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).

Primary outcomes:
measure: PSA Response Rate
timeFrame: Up to 23 months
Secondary outcomes:
measure: Incidence of Treatment-Emergent Toxicity
timeFrame: Up to 8 months
measure: Health-Related Quality of Life Scores: EPIC SF-12
timeFrame: Up to 65 months
measure: Health-Related Quality of Life Scores: MAX-PC
timeFrame: Up to 65 months
measure: Health-Related Quality of Life Scores: IPSS
timeFrame: Up to 65 months
measure: Biochemical and Clinical Failure
timeFrame: Up to 65 months
measure: Failure-free Survival (FFS)
timeFrame: Up to 65 months
measure: Overall Survival (OS)
timeFrame: Up to 65 months
measure: Measurement of Tissue Biomarker Expression
timeFrame: Up to 65 months
measure: Incidence and Relationship of Circulating DNA and Tumor Cells to Tissue Biomarkers
timeFrame: Up to 65 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Matthew C Abramowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: