Olaparib for Prostate

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
ProstateOlaparib - Drug
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial of olaparib shows that it may be effective in treating metastatic castration-resistant prostate cancer, with 11 out of 49 patients responding positively to the drug. However, more research is needed to determine the optimal timing for olaparib therapy and whether it is effective in earlier disease states.

Eligible Conditions
  • Prostate

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 2 years

12 weeks
To evaluate duration of undetectable PSA
2 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
4 weeks
Response rate (PSA) to olaparib for patients with high-risk biochemically-recurrent prostate cancer. Measured by decline in PSA to 50% of baseline level, confirmed with a second measurement at least 4 weeks apart.
6 months
To evaluate PSA progression-free survival, defined as a time from initiation on olaparib therapy until PSA increase of 25%, confirmed with another measurement at least 4 weeks later.
To evaluate time to PSA doubling from baseline

Trial Safety

Safety Progress

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

Side Effects for

sBRCAm
51%Nausea
40%Fatigue
35%Anaemia
25%Vomiting
22%Abdominal pain
20%Asthenia
16%Diarrhoea
15%Constipation
15%Dyspepsia
13%Decreased appetite
11%Oedema peripheral
11%Urinary tract infection
11%Thrombocytopenia
11%Upper respiratory tract infection
11%Arthralgia
9%Musculoskeletal pain
9%Cough
7%Alopecia
7%Back pain
7%Neutropenia
7%Abdominal pain upper
7%Dyspnoea
7%Insomnia
5%Respiratory tract infection
5%Anxiety
5%Nasopharyngitis
5%Headache
5%Depression
5%Blood creatinine increased
5%Rash
5%Glomerular filtration rate decreased
5%Mucosal inflammation
5%Vitamin d deficiency
5%Dysgeusia
5%Pruritus
5%Hypertension
4%Neutrophil count decreased
4%White blood cell count decreased
4%Pain in extremity
4%Leukopenia
4%Dizziness
4%Abdominal distension
4%Influenza like illness
4%Hypomagnesaemia
4%Pyrexia
4%Peripheral swelling
2%Platelet count decreased
2%Muscle spasms
2%Biliary colic
2%Atrial fibrillation
2%Cardiac failure
2%Deep vein thrombosis
2%Small intestinal obstruction
2%Metastases to central nervous system
2%Bronchitis
2%Alanine aminotransferase increased
2%Myalgia
2%Oropharyngeal pain
2%Dysarthria
2%Contrast media allergy
2%Femoral neck fracture
2%Colonic abscess
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT02476968) in the sBRCAm ARM group. Side effects include: Nausea with 51%, Fatigue with 40%, Anaemia with 35%, Vomiting with 25%, Abdominal pain with 22%.

Trial Design

1 Treatment Group

Olaparib 300 mg BID
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Olaparib · No Placebo Group · Phase 2

Olaparib 300 mg BID
Drug
Experimental Group · 1 Intervention: Olaparib · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

AstraZenecaIndustry Sponsor
3,993 Previous Clinical Trials
247,418,527 Total Patients Enrolled
1 Trials studying Prostate
298 Patients Enrolled for Prostate
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
536 Previous Clinical Trials
31,215 Total Patients Enrolled
Catherine H Marshall, MDPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had a prostatectomy and have tissue from the prostatectomy specimen to send for genomic and transcriptomic testing.
PSA must be >1 ng/ml post-prostatectomy.
You have had no PSA testing in the past 12 months.
You have no radiographic evidence of metastatic disease by CT scan and bone scan, performed within the prior 4 weeks.
You have a serum testosterone level of ≥ 150 ng/dl.
Hemoglobin ≥ 10.0 g/dL with no blood transfusion in the past 28 days.