Abiraterone Acetate for Prostate Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
Dana Farber Cancer Institute, Boston, MA
Prostate Cancer+1 More
Abiraterone Acetate - Drug
Eligibility
18+
Male
Eligible conditions
Prostate Cancer

Study Summary

This study is evaluating whether androgen deprivation therapy (ADT) can improve the outcome of radical prostatectomy (RP) in men with localized prostate cancer.

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Eligible Conditions

  • Prostate Cancer
  • Prostatic Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Abiraterone Acetate will improve 2 primary outcomes and 7 secondary outcomes in patients with Prostate Cancer. Measurement will happen over the course of At RP (6 months).

At 3 years post-RP
Median Biochemical Progression Free Survival (bPFS) [Part 2]
At 6 month
Median of Residual Cancer Burden (RCB) at RP
At 6 months
Intra-operative and Post-operative Complications Following RP Between Treatment Arms (1A and 1B)
Median Pre-RP PSA Nadir
At RP (6 months)
Frequency of Positive Surgical Margins
Frequency of Presenting Intraductal Carcinoma at RP
Percentage of Participants With Presenting Cribriform at RP
at 6 month
Combined pCR or MRD Rate [Part 1]
Rate of pCR at RP

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

No Control Group
Arm 2A: AAPL Adjuvant Therapy [Part 2]

This trial requires 118 total participants across 3 different treatment groups

This trial involves 3 different treatments. Abiraterone Acetate is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm 2A: AAPL Adjuvant Therapy [Part 2]Eligible Participants will be randomized to receive: AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 12 months
Arm 1B: APL Neoadjuvant Therapy [Part 1]Eligible Participants will be randomized to receive: APL: Abiraterone acetate (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/day orally) for 6 months
Arm 1A: AAPL Neoadjuvant Therapy [Part 1]Eligible Participants will be randomized to receive: AAPL: Abiraterone acetate (240 mg/day orally), Apalutamide (1000 mg/day orally), Leuprolide (22.5 mg every 12 weeks intramuscularly), Prednisone (5 mg/twice daily orally) for 6 months Pts x weeks to RP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide
FDA approved
Abiraterone
FDA approved
Apalutamide
FDA approved
Prednisone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 3 years post-rp
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 3 years post-rp for reporting.

Who is running the study

Principal Investigator
M. T.
Mary-Ellen Taplin, MD
Dana-Farber Cancer Institute

Closest Location

Dana Farber Cancer Institute - Boston, MA

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A prostate cancer that is predominantly made up of adenocarcinoma cells, with no other histological variants making up more than 50% of the sample, as determined by an academic center show original
At least 3 core biopsies must be involved in cancer to be eligible for the study show original
The patient has a Gleason score of 7 or greater and either a PSA level of greater than 20 ng/dL or evidence of T3 disease on an MRI. show original
People who want to participate in the study must be candidates for surgery and must be considered surgically resectable by a urologist. show original
The Eastern Cooperative Oncology Group (ECOG) has a performance status scale of 0 to 1, which is used to measure a person's ability to perform usual activities show original
A person has an absolute neutrophil count (ANC) of ≥ 1,500/mcL if their neutrophil count is ≥ 1,500/mcL. show original
A person's platelets should be at least 100,000/mcL three months after starting treatment, regardless of how many transfusions or growth factors they have received. show original
The person must be male and at least 18 years old. show original
There is no evidence of metastatic cancer as determined by bone scans and CT/MRI show original
Hemoglobin ≥ 9.0 g/dL

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes prostate cancer?

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The risk of developing cancer of the prostate is increased by excessive consumption of red meat. The risk also increases for men who take certain prescription drugs that may not be harmless. Smoking and drinking seem to have a protective effect.

Unverified Answer

What are the signs of prostate cancer?

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Causes may include testicular cancer or the male reproductive system. Other causes include non-malignant growths in the lining of the rectum, prostate or ureters or nerve-related conditions. Symptoms usually have a more rapid onset in men with prostate cancer.

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What are common treatments for prostate cancer?

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It is commonly accepted that radical prostatectomy is the best treatment for prostate cancer in terms of long term disease control and quality of life. It is also recognized that metastatic cases can benefit from androgen ablation; however, such treatment is not widely implemented and has not been established for the treatment of localized or nonmetastatic prostate cancer. The most commonly used medications for prostate cancer are antiandrogens to decrease testosterone production, or antiandrogens and corticosteroids to decrease the effects of androgens. Radiation therapy is commonly used for advanced prostate cancers; however, the treatment is less effective in the metastatic setting. Immunotherapy (therapy and/or vaccination to stimulate the immune system) is also being explored as a treatment.

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What is prostate cancer?

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Prostate cancer is a disease characterized by a gradual increase in the size of the prostate, the appearance and/or increase in the numbers of the cells associated with this disease, and other associated symptoms, particularly in elderly men. People over the age of 85 are the only group of people who are at risk of suffering this disease. If it is discovered to be prostate cancer, treatment of such a cancer usually is surgical removal and/or radiation. If the cancer has invaded the lining of the prostate, surgery is not appropriate and the cancer may recur. This second form of the disease is one of the leading reasons for death among those over 60 years of age.

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Can prostate cancer be cured?

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For patients with localized prostate cancer, no evidence has been found that the disease can be cured. If it is, it would be a cure of an incurable disease in the sense that the disease is no longer progressing. We find that an incurable disease has no cure, whether or not the patient believes that the disease can be cured. In these cases the aim should be to prevent disease progression rather than cure.

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How many people get prostate cancer a year in the United States?

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Around 250,000 cases of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are diagnosed each year in the United States, making it the most common cancer in American men. The disease is typically discovered when a man is in his 50s. It accounts for about 3% of cancer cases and accounts for about 3% of cancer deaths in men in the United States. Onset is frequently in the 30s, but the disease can start in any decade. The cause of prostate cancer is unknown, but risk factors for the disease include a family history of prostate cancer, African American ethnicity, and excessive exposure to phthalates.

Unverified Answer

What is the average age someone gets prostate cancer?

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• The majority of men who develop [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are between the ages of 50 and 82 years. • Although the mean age of diagnosis for prostate cancer remains the same throughout the study period, the proportion of individuals diagnosed at ages 51 or older increased from 10.1% in 1985 to 18% in 2000. • The rising proportion of men diagnosed with prostate cancer at older ages may be due to increasing use of PSA measurement to screen men; an increase in the proportion of men with advanced prostate cancer at older ages may in part be due to improved detection of cancers at early stages of disease.

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What are the chances of developing prostate cancer?

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In the case of patients without a family history of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) it was estimated that the chance of developing cancer in the prostate was 1 in 80.3 for men over 60 years of age. Because PSA levels vary widely from one patient to another, so there are great differences between these risks. Factors that increase the risk of developing prostate cancer include: being male, positive family history, and the age of the patient.

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What is abiraterone acetate?

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After 3 months of treatment, abiraterone acetate was well tolerated and was able to improve PSA and minimize the number of palpable and biopsy-proven metastases. Abiraterone acetate is active in patients with metastatic prostate cancer and has a benefit profile similar to that in nonmetastatic disease.

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Is abiraterone acetate safe for people?

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Results from a recent clinical trial of this study show no clear evidence that the use of abiraterone or androgen deprivation therapy (ADT) is associated with the development of osteoporosis or the risk for fracture in [metastatic prostate cancer](https://www.withpower.com/clinical-trials/metastatic-prostate-cancer) patients with a PSA level of<or =20 ng/mL, low-risk for prostate volume or a pre- and intra-operative PSA level of<or =100 ng/mL, who have undergone surgical castration or gonadotropin-stimulated hormonotherapy (GnRH) as part of or adjuvant to chemotherapy. The development of moderate or severe side effects with abiraterone or ADT was not significantly different.

Unverified Answer

What is the primary cause of prostate cancer?

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• Results from a recent paper suggests that the risk of PCa is associated with a more western dietary pattern, especially high-fat and high-fat/high-sugar and low-fiber diets, suggesting that a high-energy diets might play a role in the development of PCa.

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