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The goal of this study is to find out if patients with prostate cancer being treated with the medications abiraterone and prednisone can discontinue hormone injections (examples include leuprolide, goserelin, triptorelin and degarelix). Abiraterone and prednisone are pills used to treat patients with prostate cancer. When abiraterone and prednisone are used, hormone injections are usually continued to maintain a low testosterone level in the blood. This study is being done to find out if testosterone in the blood will stay low while abiraterone and prednisone are used without continued hormone injections.
Abiraterone inhibits the CYP17A enzyme, which is a critical enzyme in androgen biosynthesis. Abiraterone has regulatory approval in metastatic castration-resistant prostate cancer (mCRPC) in both chemotherapy-naïve and in the post-docetaxel setting based upon results from two randomized phase III studies. Abiraterone is also proven to extend survival in the metastatic, hormone-naïve population based on two phase III studies. Abiraterone is a castrating agent, but, other than a small first in human study, all clinical studies have been done in conjunction with gonadotropin-releasing hormone (GnRH) analogues. Maintaining castrate level of serum testosterone is critical in the treatment of metastatic prostate cancer. It is unknown if GnRH analogues must be continued to maintain castrate levels of serum testosterone in patients treated with abiraterone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone and Prednisone without a GnRH Analogue | Experimental | Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abiraterone Acetate | Drug | Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Castrate Level of Serum Testosterone | The number/percentage of patients with a castrate serum testosterone level, defined as having a serum castrate concentration <50 ng/dL when Abiraterone acetate plus prednisone (AAP) is used without GnRH analogues in metastatic prostate cancer, will be determined. Results are summarized as a number/percentage of participants. | Approximately 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Testosterone (T) Levels | Mean serum testosterone (T) concentrations in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in nanograms/deciliter (ng/dL) using basic descriptive statistics. | Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Gartrell, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25651787 | Background | Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4. | |
| 16278481 | Background | Scher HI, Sawyers CL. Biology of progressive, castration-resistant prostate cancer: directed therapies targeting the androgen-receptor signaling axis. J Clin Oncol. 2005 Nov 10;23(32):8253-61. doi: 10.1200/JCO.2005.03.4777. |
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35 participants signed informed consent forms to participate in the study. Three participants failed to meet eligibility criteria and were excluded from the protocol and one participant opted not to participate. As a result, 31 participants were enrolled into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Abiraterone and Prednisone Without a GnRH Analogue | Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of Gonadotropin-releasing hormone (GnRH) Analogue Injection Abiraterone Acetate: Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue Prednisone: Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Abiraterone and Prednisone Without a GnRH Analogue | Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection Abiraterone Acetate: Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue Prednisone: Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Percentage of Patients With Castrate Level of Serum Testosterone | The number/percentage of patients with a castrate serum testosterone level, defined as having a serum castrate concentration <50 ng/dL when Abiraterone acetate plus prednisone (AAP) is used without GnRH analogues in metastatic prostate cancer, will be determined. Results are summarized as a number/percentage of participants. | 27 of 31 patients were evaluable at ~24 weeks | Posted | Count of Participants | Participants | Approximately 24 weeks |
|
Adverse events (AEs) will be recorded from the time of consent and for at least 30 days after treatment discontinuation, up to 41 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 | Abiraterone and Prednisone Without a GnRH Analogue | Abiraterone (1000 mg daily) with Prednisone (5 mg) with Discontinuation of GnRH Analogue Injection Abiraterone Acetate: Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue Prednisone: Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Gartrell | Montefiore Medical Center | 718-405-8404 | bgartrel@montefiore.org |
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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 | Jan 27, 2025 | Sep 18, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 17, 2021 | May 29, 2025 | ICF_001.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 |
|---|---|
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Prednisone | Drug | Abiraterone Acetate with Prednisone and with Discontinuation of GnRH Analogue |
|
| Serum Luteinizing Hormone (LH) Levels | Mean serum LH levels in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in International Units/Liter (IU/L) using basic descriptive statistics. | Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment |
| Prostate-specific Antigen (PSA) Response | Mean PSA response in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in ng/mL using basic descriptive statistics. | Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment |
| Treatment-related Adverse Events Due to Toxicity | The number of patients with treatment-related adverse events due to toxicity which lead to discontinuation from the study at 24 weeks is summarized. | 24 weeks |
| Radiographic Progression-free Survival (rPFS) | The duration of time from trial entry until radiographic progression-free survival will be measured/reported. Progression-free survival is an assessment of the average time a patient lives without disease progression, as detected on radiographic imaging scans, or the patient dies from the disease, whichever comes first. Results have been summarized and reported in weeks using basic descriptive statistics. | From initiation of treatment to the end of treatment, up to approximately 41 months (~178 weeks) |
| Overall Survival (OS) | Overall survival is an assessment of survival from the time initiation of treatment until the time of death to death due to any cause. Results have been summarized and reported in weeks using basic descriptive statistics. | From initiation of treatment until the end of treatment, up to approximately 41 months |
| 28578607 | Background | Fizazi K, Tran N, Fein L, Matsubara N, Rodriguez-Antolin A, Alekseev BY, Ozguroglu M, Ye D, Feyerabend S, Protheroe A, De Porre P, Kheoh T, Park YC, Todd MB, Chi KN; LATITUDE Investigators. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer. N Engl J Med. 2017 Jul 27;377(4):352-360. doi: 10.1056/NEJMoa1704174. Epub 2017 Jun 4. |
| 28578639 | Background | James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, Ritchie AWS, Amos CL, Gilson C, Jones RJ, Matheson D, Millman R, Attard G, Chowdhury S, Cross WR, Gillessen S, Parker CC, Russell JM, Berthold DR, Brawley C, Adab F, Aung S, Birtle AJ, Bowen J, Brock S, Chakraborti P, Ferguson C, Gale J, Gray E, Hingorani M, Hoskin PJ, Lester JF, Malik ZI, McKinna F, McPhail N, Money-Kyrle J, O'Sullivan J, Parikh O, Protheroe A, Robinson A, Srihari NN, Thomas C, Wagstaff J, Wylie J, Zarkar A, Parmar MKB, Sydes MR; STAMPEDE Investigators. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy. N Engl J Med. 2017 Jul 27;377(4):338-351. doi: 10.1056/NEJMoa1702900. Epub 2017 Jun 3. |
| 7918112 | Background | Barrie SE, Potter GA, Goddard PM, Haynes BP, Dowsett M, Jarman M. Pharmacology of novel steroidal inhibitors of cytochrome P450(17) alpha (17 alpha-hydroxylase/C17-20 lyase). J Steroid Biochem Mol Biol. 1994 Sep;50(5-6):267-73. doi: 10.1016/0960-0760(94)90131-7. |
| 15150570 | Background | O'Donnell A, Judson I, Dowsett M, Raynaud F, Dearnaley D, Mason M, Harland S, Robbins A, Halbert G, Nutley B, Jarman M. Hormonal impact of the 17alpha-hydroxylase/C(17,20)-lyase inhibitor abiraterone acetate (CB7630) in patients with prostate cancer. Br J Cancer. 2004 Jun 14;90(12):2317-25. doi: 10.1038/sj.bjc.6601879. |
| 27628623 | Background | Planas J, Celma A, Placer J, Cuadras M, Regis L, Gasanz C, Trilla E, Salvador C, Lorente D, Morote J. Hormonal response recovery after long-term androgen deprivation therapy in patients with prostate cancer. Scand J Urol. 2016 Dec;50(6):425-428. doi: 10.1080/21681805.2016.1227876. Epub 2016 Sep 14. |
| 21612468 | Background | de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, Chi KN, Jones RJ, Goodman OB Jr, Saad F, Staffurth JN, Mainwaring P, Harland S, Flaig TW, Hutson TE, Cheng T, Patterson H, Hainsworth JD, Ryan CJ, Sternberg CN, Ellard SL, Flechon A, Saleh M, Scholz M, Efstathiou E, Zivi A, Bianchini D, Loriot Y, Chieffo N, Kheoh T, Haqq CM, Scher HI; COU-AA-301 Investigators. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011 May 26;364(21):1995-2005. doi: 10.1056/NEJMoa1014618. |
| 23228172 | Background | Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10. |
| 18279929 | Background | Bong GW, Clarke HS Jr, Hancock WC, Keane TE. Serum testosterone recovery after cessation of long-term luteinizing hormone-releasing hormone agonist in patients with prostate cancer. Urology. 2008 Jun;71(6):1177-80. doi: 10.1016/j.urology.2007.09.066. Epub 2008 Feb 15. |
| 16329145 | Background | Kaku H, Saika T, Tsushima T, Ebara S, Senoh T, Yamato T, Nasu Y, Kumon H. Time course of serum testosterone and luteinizing hormone levels after cessation of long-term luteinizing hormone-releasing hormone agonist treatment in patients with prostate cancer. Prostate. 2006 Mar 1;66(4):439-44. doi: 10.1002/pros.20341. |
| 26903579 | Background | Scher HI, Morris MJ, Stadler WM, Higano C, Basch E, Fizazi K, Antonarakis ES, Beer TM, Carducci MA, Chi KN, Corn PG, de Bono JS, Dreicer R, George DJ, Heath EI, Hussain M, Kelly WK, Liu G, Logothetis C, Nanus D, Stein MN, Rathkopf DE, Slovin SF, Ryan CJ, Sartor O, Small EJ, Smith MR, Sternberg CN, Taplin ME, Wilding G, Nelson PS, Schwartz LH, Halabi S, Kantoff PW, Armstrong AJ; Prostate Cancer Clinical Trials Working Group 3. Trial Design and Objectives for Castration-Resistant Prostate Cancer: Updated Recommendations From the Prostate Cancer Clinical Trials Working Group 3. J Clin Oncol. 2016 Apr 20;34(12):1402-18. doi: 10.1200/JCO.2015.64.2702. Epub 2016 Feb 22. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race/Ethnicity data was customized as all participants enrolled into the study were either Non-Hispanic Black or Hispanic/Latino. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Castration-resistant disease as AAP (Abiraterone acetate plus prednisone) indication | The number/percentage of participants who were diagnosed with castration-resistant disease as a condition for AAP treatment at baseline is summarized. | Count of Participants | Participants |
|
| Duration of Androgen deprivation therapy (ADT) prior to enrollment | The mean duration of ADT treatment, in months, is summarized at baseline. ADT treatment is used to suppress the levels of serum androgens including testosterone and control metastatic castration-resistant prostate cancer (mCRPC). | Mean | Full Range | months |
|
| Duration of Abiraterone acetate plus Prednisone (AAP) prior to enrollment | For participants on an existing AAP treatment regimen at baseline the mean duration of AAP treatment, in months, is summarized. | Mean | Full Range | months |
|
|
|
| Secondary | Serum Testosterone (T) Levels | Mean serum testosterone (T) concentrations in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in nanograms/deciliter (ng/dL) using basic descriptive statistics. | The number of patients analyzed at each timepoint is summarized in the table below. | Posted | Mean | Standard Deviation | ng/dL | Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment |
|
|
|
| Secondary | Serum Luteinizing Hormone (LH) Levels | Mean serum LH levels in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in International Units/Liter (IU/L) using basic descriptive statistics. | The number of patients analyzed at each timepoint is summarized in the table below. | Posted | Mean | Standard Deviation | IU/L | Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment |
|
|
|
| Secondary | Prostate-specific Antigen (PSA) Response | Mean PSA response in patients with metastatic prostate cancer treated with abiraterone acetate plus prednisone without a GnRH analogue was measured. Results have been summarized and reported in ng/mL using basic descriptive statistics. | The number of patients analyzed at each timepoint is summarized in the table below. | Posted | Mean | Standard Deviation | ng/mL | Baseline and 6 months, 12 months, 18 months, 24 months, and 30 months following initiation of treatment |
|
|
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| Secondary | Treatment-related Adverse Events Due to Toxicity | The number of patients with treatment-related adverse events due to toxicity which lead to discontinuation from the study at 24 weeks is summarized. | Posted | Count of Participants | Participants | 24 weeks |
|
|
|
| Secondary | Radiographic Progression-free Survival (rPFS) | The duration of time from trial entry until radiographic progression-free survival will be measured/reported. Progression-free survival is an assessment of the average time a patient lives without disease progression, as detected on radiographic imaging scans, or the patient dies from the disease, whichever comes first. Results have been summarized and reported in weeks using basic descriptive statistics. | rPFS data was not available for 1 patient. | Posted | Median | 95% Confidence Interval | weeks | From initiation of treatment to the end of treatment, up to approximately 41 months (~178 weeks) |
|
|
|
| Secondary | Overall Survival (OS) | Overall survival is an assessment of survival from the time initiation of treatment until the time of death to death due to any cause. Results have been summarized and reported in weeks using basic descriptive statistics. | OS data was not available for 1 patient. | Posted | Median | 95% Confidence Interval | weeks | From initiation of treatment until the end of treatment, up to approximately 41 months |
|
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| Post-Hoc | Percentage of Patients With a Castrate Serum Testosterone Level <50 ng/dL | The number/percentage of patients with a castrate serum testosterone level <50 ng/dL when abiraterone acetate plus prednisone is used without GnRH analogues in metastatic prostate cancer was summarized using basic descriptive statistics. | The number of patients analyzed at each timepoint is summarized in the table below. | Posted | Count of Participants | Participants | 12 months, 18 months, 24 months, and 30 months following initiation of treatment |
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| 3 |
| 31 |
| 0 |
| 31 |
| 16 |
| 31 |
| Hot Flashes | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Prostatic Obstruction | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Edema | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Weight Gain | Investigations | CTCAE (4.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| 12 months |
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| 18 months |
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| 24 months |
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| 30 months |
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| 12 months |
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| 18 months |
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| 24 months |
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| 30 months |
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| 12 Months |
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| 18 Months |
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| 24 Months |
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| 30 Months |
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| 24 months |
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| 30 months |
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