MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial

University of Miami

Status: Active, not recruiting

Conditions: Prostate Adenocarcinoma; Prostate Cancer

Treatments: Radiation: Standard Salvage Radiation Treatment (SSRT); Radiation: Mapped Tumor Salvage RT (MTSRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT01411345

20101056

Details and patient eligibility

About

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).

Full 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.

Enrollment: 37 patients

Sex: Male

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 3 patient groups

Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT)

Other group

Description:

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

Treatment:

Radiation: Standard Salvage Radiation Treatment (SSRT)

Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT)

Experimental group

Description:

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

Treatment:

Radiation: Mapped Tumor Salvage RT (MTSRT)

Phase 2: Mapped Tumor Salvage RT (MTSRT)

Experimental group

Description:

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).

Treatment:

Radiation: Mapped Tumor Salvage RT (MTSRT)