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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00167697 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| Patrick C. Walsh Fund | UNKNOWN |
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This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating double strand breaks (DSBs) in prostate cancer within patients receiving central androgen suppression and brachytherapy.
This is a prospective, single-center, two-phase study to assess the efficacy of single pulsed-dose flutamide in creating DSBs (double strand breaks) in prostate cancer within patients receiving central androgen suppression and brachytherapy. The initial phase is a 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention. All patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (>1 patients with DSBs on biopsy), then accrual will continue in the randomized, double-blind phase. Subjects will be randomized in a 2:1 ratio (12:6 patients), for an all-trial total of 18 patients receiving flutamide vs 6 patients receiving placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| flutamide | Experimental | 50mg flutamide prior to brachytherapy and prostatic biopsy |
|
| placebo | Placebo Comparator | placebo prior to brachytherapy and prostatic biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flutamide | Drug | 50mg flutamide prior to brachytherapy and prostatic biopsy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Fold-change Post Flutamide Exposure | To confirm DNA double-strand breaks occur in prostate cancer tissue following pulse-dose flutamide administration in patients who are androgen suppressed. A value less than 1 indicates a decrease and a value greater than 1 indicates an increase. | Post Flutamide exposure up to 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
males with prostate cancer
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Song, M.D. | SKCCC at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SKCCC at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38104131 | Derived | Lee E, Coulter J, Mishra A, Caramella-Pereira F, Demarzo A, Rudek M, Hu C, Han M, DeWeese TL, Yegnasubramanian S, Song DY. Induction of double-strand breaks with the non-steroidal androgen receptor ligand flutamide in patients on androgen suppression: a study protocol for a randomized, double-blind prospective trial. Trials. 2023 Dec 16;24(1):809. doi: 10.1186/s13063-023-07838-4. |
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All participants in the run-in phase received flutamide. In the second phase, additional participants were randomized, double-blind phase to receive "Flutamide" or "Placebo
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| ID | Title | Description |
|---|---|---|
| FG000 | Flutamide Run In | Single-arm run-in phase: patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (>1 patients with DSBs on biopsy), then accrual will continue in the randomized, double-blind phase 2. |
| FG001 | Phase 2: DB Flutamide | Flutamide: 50mg flutamide prior to brachytherapy and prostatic biopsy |
| FG002 | Phase 2: DB Placebo | Placebo: placebo prior to brachytherapy and prostatic biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1: Single-arm run-in Phase |
| |||||||||||||
| Period 2: Randomized, Double-blind Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Run-In | 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention. Patients within the run-in phase will receive 250mg prior to brachytherapy and prostatic biopsy |
| BG001 | Flutamide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fold-change Post Flutamide Exposure | To confirm DNA double-strand breaks occur in prostate cancer tissue following pulse-dose flutamide administration in patients who are androgen suppressed. A value less than 1 indicates a decrease and a value greater than 1 indicates an increase. | Patients with tumor tissue at biopsy. Patients that received Flutamide in Phase 2. | Posted | Mean | 95% Confidence Interval | Fold-change | Post Flutamide exposure up to 12 hours |
|
From enrollment up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flutamide Run In | Single-arm run-in phase: patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (>1 patients with DSBs on biopsy), then accrual will continue in the randomized, double-blind phase 2. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment | 1 patient went to emergency room post-treatment. Foley was replaced to address urinary retention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dana Kaplin | Johns Hopkins SOM, Dept of Radiation Oncology | 443-690-7007 | dkaplin1@jh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2021 | Jul 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005485 | Flutamide |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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The initial phase is a 6-patient single-arm run-in phase to test feasibility and rule out futility of the intervention. All patients within the run-in phase will receive 50mg flutamide prior to brachytherapy and prostatic biopsy. If futility is ruled out (>1 patients with DSBs on biopsy), then accrual will continue in the randomized in a 2:1 ratio (12:6 patients), for an all-trial total of 18 patients receiving flutamide vs 6 patients receiving placebo.
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| Placebo |
| Other |
placebo prior to brachytherapy and prostatic biopsy |
|
| NOT COMPLETED |
|
250mg flutamide prior to brachytherapy and prostatic biopsy
Flutamide: 250mg flutamide prior to brachytherapy and prostatic biopsy
| BG002 | Placebo | placebo prior to brachytherapy and prostatic biopsy Placebo: placebo prior to brachytherapy and prostatic biopsy |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
placebo prior to brachytherapy and prostatic biopsy
Placebo: placebo prior to brachytherapy and prostatic biopsy
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Flutamide | 50mg flutamide prior to brachytherapy and prostatic biopsy Flutamide: 50mg flutamide prior to brachytherapy and prostatic biopsy | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Placebo | Placebo prior to brachytherapy and prostatic biopsy Placebo: placebo prior to brachytherapy and prostatic biopsy | 0 | 5 | 0 | 5 | 1 | 5 |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D000588 |
| Amines |
| Between 18 and 65 years |
|
| >=65 years |
|