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
- Age: minimum 35 Years maximum 85 Years
- Gender: Male
- 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.
- Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
- Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
- 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).
- Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment.
- No previous pelvic radiotherapy.
- Serum total testosterone taken within 3 months prior to enrollment.
- 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.
- Ability to understand and the willingness to sign a written informed consent document.
- Zubrod performance status <
- Patients must agree to fill out quality of life/psychosocial questionnaires.
- Age ≥ 35 and ≤ 85 years.
- 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