Talazoparib for Metastatic Castration-resistant Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Brigham and Women's Hospital, Boston, MA
Metastatic Castration-resistant Prostate Cancer+2 More
Talazoparib - Drug
Eligibility
18+
Male
Eligible conditions
Select

Study Summary

Phase Ia/Ib Talazoparib + Tazemetostat for mCRPC

See full description

Eligible Conditions

  • Metastatic Castration-resistant Prostate Cancer
  • refractory, metastatic hormone-refractory Prostate cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Talazoparib will improve 2 primary outcomes and 1 secondary outcome in patients with Metastatic Castration-resistant Prostate Cancer. Measurement will happen over the course of Enrollment up to 28 days.

Year 2
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
Overall response rate (ORR)
Day 28
Rate of Dose Limiting Toxicity (DLT)

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Dose Expansion Talazoparib + Tazemetostat
1 of 2
Dose Escalation Talazoparib + Tazemetostat
1 of 2
Experimental Treatment

This trial requires 38 total participants across 2 different treatment groups

This trial involves 2 different treatments. Talazoparib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Dose Expansion Talazoparib + TazemetostatParticipants will receive talazoparib and tazemetostat at the safe dose identified in the first part (dose escalation) of the study. During each 28 day study treatment cycle participants will take: Talazoparib once daily. Tazemetostat twice daily.
Dose Escalation Talazoparib + TazemetostatStandard 3+3 dose escalation will be followed, participants will initially receive talazoparib and tazemetostat at a dose of 75% of the starting dose for their FDA-approved indications. During each 28 day study treatment cycle participants will take: Talazoparib once daily. Tazemetostat twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved
Tazemetostat
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment up to 2 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly enrollment up to 2 years for reporting.

Who is running the study

Principal Investigator
A. C.
Atish Choudhury, MD
Dana-Farber Cancer Institute

Closest Location

Brigham and Women's Hospital - Boston, MA

Eligibility Criteria

This trial is for male patients aged 18 and older. You must have received 1 prior treatment for Metastatic Castration-resistant Prostate Cancer or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have metastatic disease by bone scintigraphy or other nodal or visceral lesions on CT or MRI with a bone or soft tissue lesion amenable to image-guided percutaneous biopsy, a castrate level of testosterone (<50ng/dL), and evaluable for disease response by either
Baseline PSA ≥ 2.0 ng/mL OR Measurable disease per RECIST 1.1 NOTE: Subjects must maintain a castrate state. If they have not had an orchiectomy, they must continue to receive LHRH or GnRH agonists or antagonists unless intolerant.
Past progression on at least one novel hormonal therapy (abiraterone, enzalutamide, apalutamide, darolutamide, galeterone, orteronel, seviteronel or equivalent) in either the hormone-sensitive or castration-resistant disease setting.
progression within 12 months of completion or intolerance to prior taxane OR refusal of taxane OR contraindication to, or lack of fitness for taxane OR investigator assessment that taxane is not clinically indicated or preferred
ECOG performance status ≤1 (Karnofsky ≥70%, see Appendix A).
leukocytes ≥ 3,000/mcL
Participants must have histologically or cytologically confirmed prostate cancer (code 10036910) with progressive disease at the time of study entry by either
Sequence of at least 2 rising PSA values at a minimum of 1-week intervals
Radiographic progression per RECIST1.1 for soft tissue and/or per PCWG3 for bone, with or without PSA progression
Age ≥18 years. Children under 18 are excluded from this study as prostate cancer is a disease of adults

Patient Q&A Section

Can prostate cancer be cured?

"With the advent of a more aggressive treatment program, it has been shown that a significant number of men who have a low-risk grade [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), which has not spread to the seminal vesicles or seminal lymph nodes, have a cure in the form of a reduced risk of developing a cancer again after 20 years. This result has implications for the discussion of the treatment options and the question of when to stop treatment in low-risk prostate cancer." - Anonymous Online Contributor

Unverified Answer

What is prostate cancer?

"The prostate is a gland situated between the anus and the bones of the pelvis which secretes prostate-specific antigen (PSA) and other compounds. It is a male-specific gland that is located in the pelvis. A prostatic mass ([prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer)) is a growth of cells that is abnormal and can interfere with a patient's quality of life. It can cause urinary problems, but also presents with non-urinary symptoms such as painful sexual intercourse, sudden onset of blood in the urine, and loss of bladder control. The two forms of prostate cancer that can occur are transitional cell carcinoma and adenocarcinoma. These cancers are usually related to androgen deprivation." - Anonymous Online Contributor

Unverified Answer

What are common treatments for prostate cancer?

"The common treatments for [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) have changed significantly in the last decade. The changes in treatment options for prostate cancer may have led to changes in the rates of metastasis, survival at 5 years and overall survival. Currently, the best and safest treatment option depends on the age of the patient, staging, clinical course and type of Gleason score of prostate cancer. The primary treatment strategies for prostate cancer are radical prostatectomy, radiation therapy and hormonal therapy; which all have their own benefits and drawbacks." - Anonymous Online Contributor

Unverified Answer

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

"The number of new cases of [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer) diagnosed in men 50 years and older increased by 25% over 2008 to 2012 (approximately 6.4% of all new cases of cancer diagnosed in men 50 years and older during 2008 and 2012). Approximately 70% of new diagnoses in men 50 years and older (11.1% of all new cases of cancer diagnosed) in 2012 were based on positive prostatic specific antigen testing, although the test has now been approved for prostate cancer screening. This rise appears to be primarily driven by an increase in the proportion of PSA cases attributable to prostate cancer in men ≥50 years, particularly the increasing detection of prostate cancer in men ≥ 70 years." - Anonymous Online Contributor

Unverified Answer

What are the signs of prostate cancer?

"It is difficult to determine specific signs that have been studied so far, and the most specific sign of prostate cancer is needle biopsy. It seems obvious that the presence of an elevated PSA levels is a sign, though it is not specific for prostate cancer, but most likely because many other diseases can give similar results. So, it should not be relied on for an individual management." - Anonymous Online Contributor

Unverified Answer

What causes prostate cancer?

"This investigation found that high-fat milk consumption has a significant long-term effect on androgen level. The result did not provide strong evidence for a link to prostate cancer. Nevertheless, results suggest that an increase in prostate cancer risk from dairy may be possible." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for prostate cancer?

"For prostate cancer, the overall 5-year survival rate is 77.1% for all stages of disease. Men with pT2 prostate cancer (Tumor stage T2a) show a 5-year survival of 69.6%, while pT3 prostate cancer patients show a 5-year survival of 36.4%. The pathologic stage pT3b disease shows an in situ component has a statistically significantly higher disease-free survival compared to pT3a disease. The pT2c disease has significantly higher disease-free survival compared to pT2 disease. Men with an unfavorable pathologic disease stage (pathologic stage>T2) have a worse overall survival." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of prostate cancer?

"The data suggest that the primary cause of prostate cancer is genetic predisposition. The association between cigarette smoking and prostate cancer appears to be causative, given that quitting smoking is a major effector to reduce the risk with prostate cancer." - Anonymous Online Contributor

Unverified Answer

Is talazoparib typically used in combination with any other treatments?

"This analysis demonstrates that approximately 9% of patients treated with talazoparib alone will qualify for any of the currently available clinical trials, however, the use of any additional therapies does not appear to significantly increase the probability of completion." - Anonymous Online Contributor

Unverified Answer

How does talazoparib work?

"TZP has an important role, at least for low-risk [prostate cancer](https://www.withpower.com/clinical-trials/prostate-cancer), in treatment-line combination therapy due to its strong anti-proliferative effect. This clinical property may be associated with the inhibition of the DNA repair mechanism, especially of PAD-mediated DNA excision repair, an essential mechanism in cancer cell survival." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets prostate cancer?

"Age at diagnosis for individuals with prostate cancer can vary widely depending on the institution and study used for the measurement. The differences in age at diagnosis may explain inconsistencies in outcomes comparisons such as incidence, mortality, and/or survival. Given the potential importance of a correct diagnosis of prostate cancer in the management of patients, we believe the need to provide an accurate measure of age at diagnosis is an important limitation of reported epidemiologic studies." - Anonymous Online Contributor

Unverified Answer

What does talazoparib usually treat?

"Talazoparib has been approved by the EMEA and was first used on patients with advanced metastatic breast malignancies, mainly as first-line treatment for a variety of myeloproliferative cancers, such as myelodysplastic syndromes (MDS). Given that there is evidence of significant clinical activity in patients with other types of solid tumors, the possibility of treating other types of solid tumors with ganitumab can be considered. To elucidate the indications for using ganitumab is crucial. Therefore, the majority of the available evidence suggests that ganitumab is probably more suited for hematologic malignancies and breast cancer than solid tumors." - 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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