A Phase III Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial

Inclusion Criteria:

- A. 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.

- B. Patients with or without palpable abnormalities on digital rectal exam (DRE) are
eligible.

- C. Minimum of 3 months since prostatectomy to allow for return of urinary continence
and healing.

- D. MRI detectable lesion in prostate bed. DCE-MRI enhancing lesion in the prostate bed
should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to
enrollment.

- E. No evidence of metastatic (regional or distant) disease on the pelvic MRI.

- F. Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months
prior to enrollment.

- G. No previous pelvic radiotherapy.

- H. Serum total testosterone is within 40% of normal assay limits, taken within 34
months prior to enrollment. Patient who have been started on androgen deprivation
therapy (ADT) prior to signing consent are not required to have serum testosterone
with the range outlined; but, should have a serum testosterone level recorded prior to
enrollment.

- I. 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 ≥ 5 years then the patient is
eligible.

- J. Ability to understand and the willingness to sign a written informed consent
document.

- K. Zubrod performance status < 2.

- L. Patients must agree to fill out quality of life/psychosocial questionnaires.

- M. 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).