An interventional study of Standard Salvage Radiation Treatment (SSRT) and Mapped Tumor Salvage RT (MTSRT) in Prostate Cancer and Prostate Adenocarcinoma, sponsored by University of Miami. Active, not recruiting at 1 site in United States. Open to male participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Miami · Not applicable, Interventional, and Treatment
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.
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 37 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
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
Radiation: Standard Salvage Radiation Treatment (SSRT)
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
Radiation: Mapped Tumor Salvage RT (MTSRT)
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).
Radiation: Mapped Tumor Salvage RT (MTSRT)
A total dose of 68 Gy delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
Also known as: SSRT
Dose escalation to the imaging or Dynamic Contrast Enhanced MRI (DCE-MRI)-defined dominant region(s) by dose painting at 2.25 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 68 Gy. The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in 2.0 Gy fractions.
PSA Response Rate
Prostate-Specific Antigen (PSA) response rate is defined as the percentage of study patients with PSA less than 0.1 ng/mL at 21 months after completion of study treatment.
Time frame: Up to 23 months
Incidence of Treatment-Emergent Toxicity
Incidence of treatment-emergent toxicity in study participants. Toxicity is defined as adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs)Acute toxicity is defined as toxicity occurring during treatment and within three months of completing treatment. Late toxicity is toxicity occurring more than three months after treatment completion. Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 8 months
Health-Related Quality of Life Scores: EPIC SF-12
Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Time frame: Up to 65 months
Health-Related Quality of Life Scores: MAX-PC
Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
Time frame: Up to 65 months
Health-Related Quality of Life Scores: IPSS
Health-related quality of life (HRQOL) will be measured using the International Prostate Symptom Score (IPSS) to evaluate patient urinary function and quality of life. There are 7 questions related to urinary function. Responses are on a scale from 0 ("not at all") to 5 ("almost always"), with higher scores indicating higher levels of urinary dysfunction. There is 1 quality of life question related to urinary symptoms. Responses are on a scale from 0 ("delighted") to 6 ("terrible").
Time frame: Up to 65 months
Biochemical and Clinical Failure
The cumulative incidence of biochemical or clinical failure allowing for competing risk as needed. Clinical failure is defined as at least a 25% increase in the size of the tumor relative to the smallest volume recorded, or new extension of tumor beyond the capsule, or re-extension of tumor beyond the capsule after initial regression, or urinary obstructive symptoms with carcinoma found at transurethral resection of the prostate (TURP). Biochemical failure is defined as PSA ≥ nadir + 2 ng/mL.
Time frame: Up to 65 months
Failure-free Survival (FFS)
Rate of failure-free survival in study participants. Failure-free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status.
Time frame: Up to 65 months
Overall Survival (OS)
Rate of overall survival in study participants. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.
Time frame: Up to 65 months
Measurement of Tissue Biomarker Expression
The distribution and degree of expression of tissue biomarkers by ultrasound-directed biopsies for patients who choose to undergo the optional biopsies. Quantification of the amount of the biomarker specific immunohistochemical staining in the area of tumor.
Time frame: Up to 65 months
Incidence and Relationship of Circulating DNA and Tumor Cells to Tissue Biomarkers
To determine the incidence and relationship of circulating DNA and tumor cells to tissue biomarkers and initial complete biochemical response.
Time frame: Up to 65 months
| Milestone | Arm I: Standard Salvage Radiation Treatment (SSRT) | Arm II: Mapped Tumor Salvage RT (MTSRT) |
|---|---|---|
| Started | 15 | 22 |
| Completed | 15 | 22 |
| Not completed | 0 | 0 |
Prostate-Specific Antigen (PSA) response rate is defined as the percentage of study patients with PSA less than 0.1 ng/mL at 21 months after completion of study treatment.
| percentage of participants | Arm I: Standard Salvage Radiation Treatment (SSRT) | Arm II: Mapped Tumor Salvage RT (MTSRT) |
|---|---|---|
| PSA Response Rate | 66.6 | 85 |
Incidence of treatment-emergent toxicity in study participants. Toxicity is defined as adverse events (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs)Acute toxicity is defined as toxicity occurring during treatment and within three months of completing treatment. Late toxicity is toxicity occurring more than three months after treatment completion. Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Results for this outcome have not been posted.
Health-related Quality of Life (HRQOL) will be measured using the Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Results for this outcome have not been posted.
Health-related quality of life (HRQOL) will be measured using the scores on the Modified 18-item Memorial Anxiety Scale for Prostate Cancer (MAX-PC) from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
Results for this outcome have not been posted.
Health-related quality of life (HRQOL) will be measured using the International Prostate Symptom Score (IPSS) to evaluate patient urinary function and quality of life. There are 7 questions related to urinary function. Responses are on a scale from 0 ("not at all") to 5 ("almost always"), with higher scores indicating higher levels of urinary dysfunction. There is 1 quality of life question related to urinary symptoms. Responses are on a scale from 0 ("delighted") to 6 ("terrible").
Results for this outcome have not been posted.
The cumulative incidence of biochemical or clinical failure allowing for competing risk as needed. Clinical failure is defined as at least a 25% increase in the size of the tumor relative to the smallest volume recorded, or new extension of tumor beyond the capsule, or re-extension of tumor beyond the capsule after initial regression, or urinary obstructive symptoms with carcinoma found at transurethral resection of the prostate (TURP). Biochemical failure is defined as PSA ≥ nadir + 2 ng/mL.
Results for this outcome have not been posted.
Rate of failure-free survival in study participants. Failure-free survival is defined as the elapsed time from start of radiotherapy to first documented evidence of biochemical or clinical failure or death from any cause, whichever occurs first. In the absence of any event defining failure, follow-up time will be censored at the date of last documented failure-free status.
Results for this outcome have not been posted.
Rate of overall survival in study participants. Overall survival is defined as the elapsed time from start of radiotherapy to death from any cause. For surviving patients, follow-up will be censored at the date of last contact.
Results for this outcome have not been posted.
The distribution and degree of expression of tissue biomarkers by ultrasound-directed biopsies for patients who choose to undergo the optional biopsies. Quantification of the amount of the biomarker specific immunohistochemical staining in the area of tumor.
Results for this outcome have not been posted.
To determine the incidence and relationship of circulating DNA and tumor cells to tissue biomarkers and initial complete biochemical response.
Results for this outcome have not been posted.
Collected over 12 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I: Standard Salvage Radiation Treatment (SSRT) | 1/15 (6.7%) | 0/15 (0%) | 15/15 (100%) |
| Arm II: Mapped Tumor Salvage RT (MTSRT) | 0/22 (0%) | 4/22 (18.2%) | 21/22 (95.5%) |
| Event | Arm I: Standard Salvage Radiation Treatment (SSRT) | Arm II: Mapped Tumor Salvage RT (MTSRT) |
|---|---|---|
| Cardiac Disorders, OtherCardiac disorders | 0/15 | 1/22 |
| HematuriaRenal and urinary disorders | 0/15 | 1/22 |
| Sick Sinus SyndromeCardiac disorders | 0/15 | 1/22 |
| Ventricular tachycardiaCardiac disorders | 0/15 | 1/22 |
| Event | Arm I: Standard Salvage Radiation Treatment (SSRT) | Arm II: Mapped Tumor Salvage RT (MTSRT) |
|---|---|---|
| FatigueGeneral disorders | 13/15 | 13/22 |
| Urinary frequencyRenal and urinary disorders | 8/15 | 13/22 |
| Testicular disorderReproductive system and breast disorders | 3/15 | 12/22 |
| Urinary frequencyRenal and urinary disorders | 7/15 | 7/22 |
| Cystitis noninfectiveRenal and urinary disorders | 3/15 | 10/22 |
| HematuriaRenal and urinary disorders | 5/15 | 10/22 |
| DiarrheaGastrointestinal disorders | 6/15 | 5/22 |
| Urinary incontinenceRenal and urinary disorders | 6/15 | 8/22 |
| Hot flashesVascular disorders | 2/15 | 7/22 |
| NauseaGastrointestinal disorders | 4/15 | 4/22 |
| Age, Categorical(Participants) | Arm I: Standard Salvage Radiation Treatment (SSRT) | Arm II: Mapped Tumor Salvage RT (MTSRT) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 15 | 24 |
| >=65 years | 6 | 7 | 13 |
| Sex: Female, Male(Participants) | Arm I: Standard Salvage Radiation Treatment (SSRT) | Arm II: Mapped Tumor Salvage RT (MTSRT) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 15 | 22 | 37 |
| Ethnicity (NIH/OMB)(Participants) | Arm I: Standard Salvage Radiation Treatment (SSRT) | Arm II: Mapped Tumor Salvage RT (MTSRT) | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 8 | 12 |
| Not Hispanic or Latino | 11 | 14 | 25 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I: Standard Salvage Radiation Treatment (SSRT) | Arm II: Mapped Tumor Salvage RT (MTSRT) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 4 | 6 |
| White | 13 | 18 | 31 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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