An interventional study of stereotactic body radiotherapy in Prostate Cancer, sponsored by Mercy Research. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-23.
Sponsored by Mercy Research · Not applicable, Interventional, and Treatment
Among 3,595 studies in Prostatic Neoplasms with a site in United States — 612 open to participants now, 980 under way, 101 of them phase 3. Prostatic Neoplasms · United States.
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, this one is the 1,034th largest by enrollment of the 3,023 interventional ones, is one of 130 that started in 2011, is one of 764 with no phase, and was the 1,210th registered.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 84 is above the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →612 of the 3,595 studies in Prostatic Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →3,595 studies; the count open now beside each. This study's row is marked.
First in 1988; this study’s year is marked. 130 started in 2011.
Median enrollment 48 across the 3,023 interventional studies, 157 across the 477 observational. Of the 2,355 that completed or were terminated, 997 (42%) have results posted.
921 of 3,595 have an industry lead sponsor. The 10 most frequent:
Mercy Research is the lead sponsor of 17 studies on the registry; none are open to participants now.
Mercy Research has 1 study filed under Prostatic Neoplasms — fewer than ten, so there is no comparison to draw.
341 of the studies in Prostatic Neoplasms with a site in United States that are under way reach primary completion within a year, 26 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04134260Phase 3NRG OncologyTesting the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial | 2026-11-01 |
| NCT03348670Phase 3Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairPharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms | 2026-11-18 |
| NCT03767244Phase 3Janssen Research & Development, LLCA Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy | 2026-12-01 |
| NCT06970847Phase 3Clarity Pharmaceuticals Ltd64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer | 2026-12-31 |
| NCT02446405Phase 3University of SydneyEnzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer | 2026-12-31 |
Among the 3,595 studies in Prostatic Neoplasms with a site in United States, from their registry updates:
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of organ confined prostate cancer.
This is a single site, non-randomized, prospective, phase IV trial of patients with organ-confined prostate cancer. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues,tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Radiation: stereotactic body radiotherapy
Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
Biochemical Control Rate
Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.
Time frame: one year
Late Toxicity Rate
Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.
Time frame: one year
| Milestone | Stereotactic Body Radiotherapy |
|---|---|
| Started | 84 |
| Completed | 72 |
| Not completed | 12 |
Serial blood tests for prostate specific antigen (PSA) levels will be obtained at regular intervals (every 3 months).The "Phoenix definition" for biochemical recurrence (nadir + 2 ng/ml) will be used. Biochemical control rate will be expressed based on subjects experiencing tumor control (complete, partial, or stable) vs. subjects experiencing disease progression.
| Participants | Stereotactic Body Radiotherapy |
|---|---|
| Complete, partial, or stable tumor control | 71 |
| Disease progression | 0 |
Toxicity will be recorded as a measure of patients who experienced adverse events within 1 year of study treatment.
| Participants | Stereotactic Body Radiotherapy |
|---|---|
| Patients who experienced no adverse events | 68 |
| Patients who experienced adverse events | 6 |
Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stereotactic Body Radiotherapy | 0/72 (0%) | 1/74 (1.4%) | 5/74 (6.8%) |
| Event | Stereotactic Body Radiotherapy |
|---|---|
| GU BleedingRenal and urinary disorders | 1/74 |
| Event | Stereotactic Body Radiotherapy |
|---|---|
| Change in urinary frequencyRenal and urinary disorders | 4/74 |
| ImpotenceReproductive system and breast disorders | 1/74 |
| DysuriaRenal and urinary disorders | 1/74 |
| Age, Categorical(Participants) | Stereotactic Body Radiotherapy |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 61 |
| Age, Continuous(years) | Stereotactic Body Radiotherapy |
|---|---|
| Mean | 68 (54 to 82) |
| Sex: Female, Male(Participants) | Stereotactic Body Radiotherapy |
|---|---|
| Female | 0 |
| Male | 84 |
| Race (NIH/OMB)(Participants) | Stereotactic Body Radiotherapy |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 66 |
| More than one race | 0 |
| Unknown or Not Reported | 11 |
| Region of Enrollment(participants) | Stereotactic Body Radiotherapy |
|---|---|
| United States | 84 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of Jun 2011, a primary completion of Apr 2019 and a completion of Apr 2019. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2020, 1 year 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Mercy Research