Biopsy for Prostate Cancer

University of Florida Health Science Center - Gainesville, Gainesville, FL
Prostate Cancer+62 More ConditionsBiopsy - Procedure
All Sexes

Study Summary

This trial is testing if talazoparib works in patients with advanced cancer who have mutations in their DNA repair genes. Talazoparib is a drug that blocks PARP, a protein that helps repair damaged DNA. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die.

Eligible Conditions
  • Castration-resistant Prostate Cancer
  • Metastatic Cancer
  • Metastatic Breast Cancer
  • Prostate Cancer
  • Stage III Pancreatic Cancer
  • Pancreatic Cancer
  • Stage III Gastric Cancer
  • Breast Cancer
  • Stomach Cancer
  • Metastatic Pancreatic Endocrine Carcinoma
  • Stage IV Gastric Cancer
  • Locally Advanced Malignant Solid Tumor
  • Postneoadjuvant Therapy Stage IV Gastric Cancer
  • Stage III Prostate Cancer
  • Stage IV Pancreatic Cancer
  • Stage IIIB Breast Cancer
  • Stage III Breast Cancer
  • Ovarian Cancer
  • Stage IVA Gastric Cancer
  • Stage IVB Gastric Cancer
  • Stage IV Breast Cancer
  • HER2-positive Breast Cancer
  • Stage IIIB Gastric Cancer
  • Stage IIIA Ovarian Cancer
  • Stage IIIA1 Ovarian Cancer
  • Stage III Ovarian Cancer
  • Stage IV Prostate Cancer
  • Stage IVA Ovarian Cancer
  • Postneoadjuvant Therapy Stage III Gastric Cancer
  • Stage IIIA Gastric Cancer
  • Stage IVB Ovarian Cancer
  • Stage IIB Pancreatic Cancer
  • Stage IIIA2 Ovarian Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIA Prostate Cancer
  • Stage IVA Prostate Cancer
  • Stage IIA Pancreatic Cancer
  • Stage IIIB Ovarian Cancer
  • Stage IIIB Prostate Cancer
  • Cancer
  • Gastric Cancer
  • Stage II Pancreatic Cancer
  • Stage IVB Prostate Cancer
  • Hormone-Refractory Prostate Cancer
  • Stage IV Ovarian Cancer
  • Platinum-Sensitive Ovarian Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Up to 30 days after last dose

Day 2
Percent of patients who demonstrate simultaneous Rad51 activation
Day 30
Overall response rate
Tumor genomic alterations potentially associated with sensitivity or acquired resistance to talazoparib

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

1 Treatment Group

Treatment (talazoparib)
1 of 1

Experimental Treatment

36 Total Participants · 1 Treatment Group

Primary Treatment: Biopsy · No Placebo Group · Phase 2

Treatment (talazoparib)Experimental Group · 2 Interventions: Biopsy, Talazoparib · Intervention Types: Procedure, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 30 days after last dose

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,283 Previous Clinical Trials
41,235,362 Total Patients Enrolled
544 Trials studying Prostate Cancer
503,656 Patients Enrolled for Prostate Cancer
A P ChenPrincipal InvestigatorNational Cancer Institute LAO
6 Previous Clinical Trials
506 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 3 months.
People with pancreatic cancer.
Patients who have been diagnosed with stomach cancer.
Patients with ovarian cancer are included in the study.
If you have breast cancer and are eligible for a PARP inhibitor according to FDA rules, you must have taken a PARP inhibitor before. The time and treatment details of your prior use of PARP inhibitor must be recorded.
Patients with breast cancer are eligible for the trial.
You must have a tumor that can be safely biopsied. The tumor selected for biopsy cannot be one that is being used to measure the effectiveness of the treatment.
You have cancer that has come back after treatment, or cancer that has spread to other parts of your body.

Frequently Asked Questions

Is recruitment still taking place for this trial?

"As per, the recruitment process for this research is currently ongoing. It was initially published on December 29th 2020 and has had its most recent update as of July 27th 2022." - Anonymous Online Contributor

Unverified Answer

How secure is Biopsy for individuals?

"Due to the limited data available on biopsy's efficacy, our team has assigned it a score of 2 in regards to safety. This is based on its Phase 2 trial status." - Anonymous Online Contributor

Unverified Answer

How many participants have been included in this clinical research so far?

"According to the specified criteria, 36 people must participate in this investigation. Subjects can join from different hubs such as University of Florida Health Science Center - Gainesville and University of Oklahoma Health Sciences Centre." - Anonymous Online Contributor

Unverified Answer

Could you elaborate on any additional investigations involving Biopsy?

"In 2010, the City of Hope was at the forefront of biopsy research. Since then, 63 trials have concluded and 58 are still active; a majority of these occuring in Gainesville, Florida." - 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.