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


Condition: Prostate Cancer, Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT01411345

Sponsor: University of Miami

Phase: Phase 2/Phase 3

Eligibility:

  • Age: minimum 35 Years maximum 85 Years
  • Gender: Male

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 <
  12. Patients must agree to fill out quality of life/psychosocial questionnaires.
  13. Age ≥ 35 and ≤ 85 years.

Exclusion Criteria:

  1. 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).

View trial on ClinicalTrials.gov


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