Talazoparib for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NY
Prostate Cancer+5 More
Talazoparib - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called talazoparib may help treat prostate cancer.

See full description

Eligible Conditions

  • Prostate Cancer
  • Adenocarcinoma, Prostate
  • Neoplasms of the Prostate
  • Castration-resistant Prostate Cancer
  • refractory, metastatic hormone-refractory Prostate cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Prostate Cancer

Study Objectives

This trial is evaluating whether Talazoparib will improve 2 primary outcomes in patients with Prostate Cancer. Measurement will happen over the course of 30 days after last dose of study treatment (+/- 3 days).

Day 30
Phase I: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Phase II: Overall Response Rate

Trial Safety

Safety Progress

1 of 3

Other trials for Prostate Cancer

Trial Design

1 Treatment Group

Metastatic Castration Resistant Prostate Cancer
1 of 1
Experimental Treatment

This trial requires 55 total participants across 1 different treatment group

This trial involves a single treatment. Talazoparib is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Metastatic Castration Resistant Prostate CancerParticipants have Metastatic Castration Resistant Prostate Cancer and No Mutations in DNA Damage Repair
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved
Temozolomide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days after last dose of study treatment (+/- 3 days)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 days after last dose of study treatment (+/- 3 days) for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

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:
Soft-tissue progression per RECISTv1.1
Progression of bone disease (evaluable disease) or tow or more new bone lesions by bone scan
Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information or have their legally authorized representative provide written informed consent. A signed informed consent must be obtained prior to performing screening procedures.
NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
Males 18 years of age or above
Histologically or cytologically confirmed adenocarcinoma of the prostate
Bilateral orchiectomy or ongoing androgen deprivation therapy with a GnRH agonist/antagonist (surgical or medical castration)
Progression of mCRPC on treatment with at least 1 second generation hormonal agent (e.g., enzalutamide and/or abirateroneacetate/prednisone)
PSA progression defined as at least 2 rises in PSA with a minimum of a 1-week interval
1.0 ng/mL is the minimal starting value if confirmed rise is only indication of progression

Patient Q&A Section

What are common treatments for prostate cancer?

"Most Pca have been treated with radical prostatectomy, but hormonal therapy has replaced this as the first-line option. Androgen-deprivation therapy has been used to treat patients with advanced disease. And adjuvant therapies are being investigated." - Anonymous Online Contributor

Unverified Answer

Can prostate cancer be cured?

"Prostate cancer curative treatments are available. The potential for curative treatments to impact on the long-term survival is a challenging issue facing modern [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) management. However, further studies examining the role of early prostate-specific antigen in the detection of curative cancer are required." - Anonymous Online Contributor

Unverified Answer

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

"About 60,000 new cases of prostate cancer are diagnosed annually in the United States. This represents 31.9% of all new cases of prostate cancer. This is one of the highest rates of prostate cancer in the world." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"The major risk factors for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) are age, ethnicity and family history. The strongest single risk factor for prostate cancer is familial cancer in a close family relative. The risk of prostate cancer increases with degree of relatedness. The risk is also related to the age of the patient, which is lower in the relatives with less than 50% relatedness. Prostate cancer risk also is lower in the spouses of patients with prostate cancer. There is no increased risk for spouses of persons with prostate cancer from any other familial cancer, nor is there any increased risk when a spouse has breast, ovarian or gastric cancer or a male relative has cancer of the female genital tract." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"Prostate disease may develop gradually or suddenly, and may be detected as a result of a routine physical examination. Most [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)s are not evident on physical examination, and if they are they are typically non-specific. However, if found during the physical examination other signs may indicate the possibility of prostate cancer." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"Contrary to popular belief, prostate cancer affects a significantly greater percentage of men than women. In 2007, prostate cancer affected 233,000 men in the United States, of which only 4,050 were diagnosed with a more serious prostate cancer." - Anonymous Online Contributor

Unverified Answer

Does prostate cancer run in families?

"Although the genetic etiology of prostate cancer remains largely unknown, the present observational study highlights the contribution of genetic factors to familial prostate cancer. We also confirmed that familial prostate cancer, the majority of which occurs in relatives of patients with aggressive prostate cancer, should be considered a "rule" of thumb." - Anonymous Online Contributor

Unverified Answer

Does talazoparib improve quality of life for those with prostate cancer?

"Although only a small subset of patients in clinical trials had baseline scores of sufficient quality, the results from this first phase II trial with talazoparib demonstrated that in this patient population, talazoparib significantly improved quality of life. Talazoparib was associated with a marked improvement in patient-reported physical and social functioning, although its activity is currently limited by a short half-life, although long term toxicities have yet to be reported, therefore long term efficacy remains to be determined." - Anonymous Online Contributor

Unverified Answer

How serious can prostate cancer be?

"Almost half of men with [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) had a Gleason score of 8 or higher, which corresponds to a 5-year survival rate after diagnosis of 20% with a 10-year survival rate at 3.2%. Although prostate cancer has a low survival rate after diagnosis, the long-term risks of prostate cancer are low compared with other cancers." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for prostate cancer?

"Older men with LUTS and high likelihood of disease at presentation would benefit the most from a prostate-specific antigen screening program. These cohorts should be counseled, counseled, and referred to the Mayo Clinic for further evaluation. Physicians should consider offering them a clinical trial to determine whether prostate cancer is actually under control with a standard treatment regimen. For those men, the benefits of such a trial are not only in relieving the LUTS of the bladder but by giving the patients access to the best data available from the current literature regarding the specific, best-standard prostate cancer regimen that would provide longest life expectancy and minimize side-effects." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing prostate cancer?

"The risk of disease is not an independent variable. Risk of all [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)s was 1.9% on the basis of the best available study reports (Grundy, 1998; Leloup, 1999). Risk of any form of prostate cancer is not constant. The relative risk of aggressive cancer is higher in populations of higher rates of prostate-specific antigen-detect prostate cancer. The relative risk of low-grade cancer, in populations with lower rates of detection, is greater. The probability of developing any prostate cancer in a family member may increase if both parents were men, but increased awareness and screening may also account for the higher incidence of prostate cancer seen in families." - Anonymous Online Contributor

Unverified Answer

What does talazoparib usually treat?

"Patients with progressive metastatic castration-refractory prostate cancer typically receive combination therapy with androgen axis targeting chemotherapy and/or the synthetic retinoid analog talazoparib in addition to androgen deprivation. The clinical experience gathered during multiple phase III trials of the above agents as second-line, salvage, and/or third-line chemotherapy for patients with castration resistant prostate cancer has led to a more accurate appreciation of their respective roles as therapy, and more nuanced application of these agents in the clinical setting." - Anonymous Online Contributor

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