Prostate AdenocarcinomaPhase 2NCT04288687
A Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects
A Phase 2 study testing Niraparib Pill in people with Prostate Adenocarcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This study is designed to evaluate the initial safety and effectiveness of an investigational drug, niraparib, given to patients who have recently received platinum-based chemotherapy for the treatment of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma
- What is being tested?
- Niraparib Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2020to 20 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma (mixed histology will be acceptable, but pure small cell histology is to be excluded).
- ≥ 18 years of age.
- No prior therapy with PARP inhibitor therapy.
- Patients must have received at least 9 weeks of platinum-based chemotherapy for the treatment of mCRPC as the proximal treatment regimen prior to study screening. Patients must not have evidence of clinical or radiographic disease progression (per Investigator assessment) and should have adequately recovered from chemotherapy-related toxicities (at least 4 weeks following completion of chemotherapy, with treatment-related toxicities ≤ grade 1 per CTCAE version 5).
- ECOG performance status of ≤ 2.
- Documented evidence of a pathogenic or likely pathogenic DNA repair aberration in BRCA1/2, ATM, FANCA, PALB2, CHEK2, HDAC2, or BRIP1 through either somatic or germline testing from a CLIA certified laboratory.
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- Radiographic evidence for metastatic disease. Measureable disease (per RECIST) is not required for enrollment. (i.e. bone-only metastatic disease is permitted).
- Patients with history of treated brain metastases are eligible if off systemic corticosteroids for at least 2 weeks.
- Clinical evidence for castration-resistance, with total testosterone < 50 ng/dL. Patients who have not undergone bilateral orchiectomy must plan to continue ongoing androgen deprivation therapy for the duration of the trial therapy.
- Patients must have adequate organ function, as confirmed by laboratory values obtained ≤ 14 calendar days prior to the first day of study therapy:
- Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused)
- Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver). (Note: In subjects with Gilbert's syndrome, if total bilirubin is >1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, subject may be eligible)
- Renal: Estimated creatinine clearance ≥ 45 mL/min using Cockcroft Gault formula.
- Patients must have a projected life expectancy of at least 3 months.
Who cannot join
- Prior therapy with a PARP inhibitor.
- Presence of clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Presence of known significant immunodeficiency, as determined by the treating investigator.
- Presence of clinically significant active infections, as determined by the treating investigator.
- Known allergy to niraparib or any of its components.
- Prostate cancer with histologic evidence for pure small cell histology
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: PLATPARP: A Phase II Single-Arm Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects
This study is designed to evaluate the initial safety and effectiveness of an investigational drug, niraparib, given to patients who have recently received platinum-based chemotherapy for the treatment of prostate cancer. The study enrolls participants with history of advanced prostate cancer that is growing despite standard hormonal therapies, such as androgen-deprivation therapy.
- Conditions
- Prostate Adenocarcinoma
- Being tested
- Niraparib Pill
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niraparib PillDrug
Niraparib 200 mg by mouth daily (2 x 100 mg pills)
| Study group | Role | What they receive |
|---|---|---|
| Niraparib Arm (only arm) | Other | Niraparib 200 mg by mouth daily (2 x 100 mg pills) on a 28 day cycle Receives: Drug: Niraparib Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Month Radiographic Progression-Free Survival (rPFS6)
Proportion of participants alive without radiographic progression (per PCWG2 criteria), clinical deterioration (as assessed by the investigator), or death from any cause, measured from the start of maintenance niraparib therapy using Kaplan-Meier analysis.
Measured: 6 months from initiation of maintenance niraparib therapy
Secondary outcomes (4)
Number of Participants With PSA50 Response
Number of participants achieving a ≥50% decline in serum PSA from baseline while on maintenance niraparib therapy. Participants with baseline PSA <0.5 ng/mL will be excluded from this analysis.
Measured: From baseline until end of treatment, or up to 24 months
Number of Participants With PSA30 Response
Number of participants achieving a ≥30% decline in serum PSA from baseline while on maintenance niraparib therapy. Participants with baseline PSA <0.5 ng/mL will be excluded from this analysis.
Measured: From baseline until end of treatment, or up to 24 months
Time to PSA Progression
Time from initiation of maintenance niraparib therapy to the first PSA increase >25% and ≥2 ng/mL from nadir, per PCWG2 criteria. Participants with baseline PSA <0.5 ng/mL were not evaluable. Participants without an event were censored at the last PSA assessment.
Measured: From baseline until end of treatment, or up to 24 months
Overall Survival (OS)
Time from initiation of maintenance niraparib therapy to death from any cause, estimated by Kaplan-Meier analysis.
Measured: From initiation of maintenance niraparib therapy until death from any cause, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start19 Oct 2020
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivek Narayan, MD, Principal investigator, Ambramson Cancer Center of the University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288687
- Sponsor's protocol ID
- UPCC 21819
- Status last verified
- Jan 2026
- First submitted
- 26 Feb 2020
- Last updated
- 4 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Will not need to use IPD
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PLATPARP: A Phase II Single-Arm Trial of Niraparib in Platinum-Sensitive Castration-Resistant Prostate Cancer With DNA Repair Defects
- ClinicalTrials.gov ID
- NCT04288687
- Acronym / sponsor ID
- UPCC 21819
- Conditions
- Prostate Adenocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 28 Feb 2020 (actual)
- Results
- Posted 4 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the initial safety and effectiveness of an investigational drug, niraparib, given to patients who have recently received platinum-based chemotherapy for the treatment of prostate cancer. The study enrolls participants with history of advanced prostate cancer that is growing despite standard hormonal therapies, such as androgen-deprivation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib Arm (only arm) | Other | Drug: Niraparib PillNiraparib 200 mg by mouth daily (2 x 100 mg pills) on a 28 day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma (mixed histology will be acceptable, but pure small cell histology is to be excluded).
- ≥ 18 years of age.
- No prior therapy with PARP inhibitor therapy.
- Patients must have received at least 9 weeks of platinum-based chemotherapy for the treatment of mCRPC as the proximal treatment regimen prior to study screening. Patients must not have evidence of clinical or radiographic disease progression (per Investigator assessment) and should have adequately recovered from chemotherapy-related toxicities (at least 4 weeks following completion of chemotherapy, with treatment-related toxicities ≤ grade 1 per CTCAE version 5).
- ECOG performance status of ≤ 2.
Key exclusion criteria (6 listed)
- Prior therapy with a PARP inhibitor.
- Presence of clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Presence of known significant immunodeficiency, as determined by the treating investigator.
- Presence of clinically significant active infections, as determined by the treating investigator.
- Known allergy to niraparib or any of its components.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niraparib PillNiraparib 200 mg by mouth daily (2 x 100 mg pills) | Drug | Niraparib Arm (only arm) |
Primary outcome
6-Month Radiographic Progression-Free Survival (rPFS6)
Time frame: 6 months from initiation of maintenance niraparib therapy
Proportion of participants alive without radiographic progression (per PCWG2 criteria), clinical deterioration (as assessed by the investigator), or death from any cause, measured from the start of maintenance niraparib therapy using Kaplan-Meier analysis.
4 secondary outcomes
Number of Participants With PSA50 Response
Time frame: From baseline until end of treatment, or up to 24 months
Number of Participants With PSA30 Response
Time frame: From baseline until end of treatment, or up to 24 months
Time to PSA Progression
Time frame: From baseline until end of treatment, or up to 24 months
Overall Survival (OS)
Time frame: From initiation of maintenance niraparib therapy until death from any cause, up to 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Will not need to use IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivek Narayan, MD principal investigator
Ambramson Cancer Center of the University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Niraparib Pill in people with Prostate Adenocarcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Month Radiographic Progression-Free Survival (rPFS6) (time frame: 6 months from initiation of maintenance niraparib therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.