Number of Participants Disease-free Until Completion of Treatment (2 Years From Start of ADT)
| Group | Value |
|---|---|
| Phase II, Arm I (GnRH, IMRT) | not posted |
| Phase II, Arm II (Niraparib, GnRH, IMRT) | not posted |
Trial · Interventional
CompletedPhase 1/2Results postedRegistry dataUnited States, Canada
1 trial · 1 completed · 1 with posted results
Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring
NCT040372548 Oct 2019 to 23 Dec 2025
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is a phase I-II trial to find the safety and activity of adding a new drug (neraparib) to the usual treatment (radiation combined with male hormone deprivation therapy) in lowering the chance of prostate cancer growing or returning. Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Adding niraparib to the usual care may lower the chance of prostate cancer growing or returning.
Experimental
Phase I, Dose Level 1 (niraparib, GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. \*Niraparib dose level 1: 100 mg.
Experimental
Phase I, Dose Level 2 (niraparib, GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. \*Niraparib dose level 2: 100 mg during IMRT 200 mg otherwise.
Experimental
Phase I, Dose Level 3 (niraparib, GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment given in the absence of disease progression or unacceptable toxicity. \*Niraparib dose level 3: 200 mg.
Active comparator
Phase II, Arm I (GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.
Experimental
Phase II, Arm II (niraparib, GnRH, IMRT)
Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD (phase I determined dose level) for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.
Outcomes the sponsor listed as primary.
Number of Participants Disease-free Until Completion of Treatment (2 Years From Start of ADT)
Time frame · Baseline to completion of treatment (two years from start of ADT)
Participants will be considered disease-free if their PSA values remain below 0.1 ng/ml until the completion of treatment. The proportion of patients disease-free at 24 months were to be compared in the two treatment arms using a non-continuity-corrected chi-square test. PSA levels will be assessed prior to the start of RT, at the end of RT, and every three months for 24 months. all PSA values obtained up to and including the two-year landmark must be \< 0.1 ng/ml. Patients who die prior to two years from prostate cancer will be counted as failures. Patients who die from causes other than prostate cancer will be considered non-evaluable for the primary endpoint. Patients still under follow-up but who have a missing PSA value at two years or more than two missing values prior to two years will also be counted as failures.
Percent of Participants Alive (Overall Survival)
Time frame · From baseline to death or last follow-up, analyzed after phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a log-rank test.
Percentage of Participants With Prostate Cancer Deaths (Prostate Cancer-specific Survival)
Time frame · From baseline to death or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Prostate cancer death rates were to be estimated using the cumulative incidence method, treating deaths due to other causes as competing risks. The treatment arms were to be compared using the Fine-Gray test
Percentage of Participants With Pathologic Complete Response (pCR) at Two Years
Time frame · At two years
Complete response was to be determined by a12-core biopsy. Treatment arms were to be compared using a chi-square test.
Percentage of Participants With Local/Regional or Distant Progression
Time frame · From baseline to local/regional or distant progression, death, or last follow-up, whichever occurs first, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Progression rates were to be estimated using the cumulative incidence method, treating deaths as competing risks. The treatment arms were to be compared using the Fine-Gray test
Percentage of Participants With Distant Metastases
Time frame · From baseline to distant metastasis, death, or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Distant metastases rates were to be estimated using the cumulative incidence method, treating death as a competing risk. The treatment arms were to be compared using the Fine-Gray test
Percentage of Participants Alive Without Biochemical Progression (Biochemical Progression-free Survival)
Time frame · From baseline to biochemical progression or last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Biochemical progression is defined as PSA ≥ 2 ng/ml over the nadir PSA, the presence of local, regional, or distant recurrence, or death from prostate cancer. Biochemical progression-free survival rates were to be estimated using the Kaplan-Meier method and the treatment arms were to be compared using a log-rank test.
Number of Participants by Highest Grade Adverse Event Reported
Time frame · From baseline to last follow-up, analyzed after all phase II participants have been followed for two years, which was expected to occur 3.5 years from start of phase II component.
Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Adverse events were to be categorized as early (within 90 days of completion of radiotherapy) or late (more than 90 days after the completion of radiotherapy).The number of participants per grade was to be compared between the arms for early, late, and all adverse events using chi-square or Fisher exact tests
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value |
|---|---|
| Phase II, Arm I (GnRH, IMRT) | not posted |
| Phase II, Arm II (Niraparib, GnRH, IMRT) | not posted |
| Group | Value |
|---|---|
| Phase II, Arm I (GnRH, IMRT) | not posted |
| Phase II, Arm II (Niraparib, GnRH, IMRT) | not posted |
| Group | Value |
|---|---|
| Phase II, Arm I (GnRH, IMRT) | not posted |
| Phase II, Arm II (Niraparib, GnRH, IMRT) | not posted |
| Group | Value |
|---|---|
| Phase II, Arm I (GnRH, IMRT) | not posted |
| Phase II, Arm II (Niraparib, GnRH, IMRT) | not posted |
| Group | Value |
|---|---|
| Phase II, Arm I (GnRH, IMRT) | not posted |
| Phase II, Arm II (Niraparib, GnRH, IMRT) | not posted |
| Group | Value |
|---|---|
| Phase II, Arm I (GnRH, IMRT) | not posted |
| Phase II, Arm II (Niraparib, GnRH, IMRT) | not posted |
| Group | Value |
|---|---|
| Phase II, Arm I (GnRH, IMRT) | not posted |
| Phase II, Arm II (Niraparib, GnRH, IMRT) | not posted |
| Group | Value |
|---|---|
| Phase II, Arm I (GnRH, IMRT) | not posted |
| Phase II, Arm II (Niraparib, GnRH, IMRT) | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Phase I, Dose Level 1 (Niraparib, GnRH, IMRT)Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. \*Niraparib dose level 1: 100 mg. | 0 / 6 | 3 / 6 | 6 / 6 |
| Phase I, Dose Level 2 (Niraparib, GnRH, IMRT)Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity. \*Niraparib dose level 2: 100 mg during IMRT 200 mg otherwise. | 0 / 5 | 3 / 5 | 5 / 5 |
| Phase I, Dose Level 3 (Niraparib, GnRH, IMRT)Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment given in the absence of disease progression or unacceptable toxicity. \*Niraparib dose level 3: 200 mg. | 0 / 6 | 3 / 6 | 6 / 6 |
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