Olaparib for Prostate Cancer

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

Study Summary

This trial is testing a new combination of treatments for men with castration sensitive prostate cancer that has spread to a limited number of sites. The goal is to see if this new combination is safe and effective.

Eligible Conditions
  • Prostate Cancer
  • Castrate Sensitive Prostate Cancer
  • Oligometastatic Disease

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 24 months after enrollment

24 months after enrollment
Percentage of patients without treatment failure at 24 months
Month 36
Frequency of adverse events grade 3 or higher and attributable to study treatment
Percentage of patients with undetectable PSA, testosterone >150 ng/dL and without treatment failure.
Time to subsequent therapy (e.g. ADT, radiation)
Month 36
Rate of obtaining an optimal PSA (PSA ≤ 0.2 ng/mL)
Time to Androgen Deprivation Therapy (ADT) restart

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%Back pain
7%Alopecia
7%Neutropenia
7%Abdominal pain upper
7%Dyspnoea
7%Insomnia
5%Anxiety
5%Nasopharyngitis
5%Respiratory tract infection
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

Abiraterone, ADT, Radiation and Olaparib
1 of 1

Experimental Treatment

29 Total Participants · 1 Treatment Group

Primary Treatment: Olaparib · No Placebo Group · Phase 2

Abiraterone, ADT, Radiation and OlaparibExperimental Group · 5 Interventions: Abiraterone, External Beam Radiotherapy, Androgen Deprivation Therapy (ADT), Olaparib, Prednisone · Intervention Types: Drug, Radiation, Biological, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
FDA approved
External Beam Radiotherapy
1995
Completed Phase 3
~440
Androgen Deprivation Therapy (ADT)
2005
Completed Phase 3
~530
Olaparib
FDA approved
Prednisone
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months after enrollment

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
267 Previous Clinical Trials
18,102 Total Patients Enrolled
26 Trials studying Prostate Cancer
2,922 Patients Enrolled for Prostate Cancer
Zachery Reichert, MD, PhDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
2 Previous Clinical Trials
19 Total Patients Enrolled
1 Trials studying Prostate Cancer
13 Patients Enrolled for Prostate Cancer

Eligibility Criteria

Age 18+ · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of prostate cancer that is not of the adenocarcinoma type.
You have newly diagnosed oligometastatic prostate cancer based on molecular imaging (e.g
The patient must have a molecular positive disease that can be treated safely per standard radiation oncology principles.
You have had a radical prostatectomy, and have positive surgical margins.
A newly diagnosed oligometastatic disease requires that no prior image guided radiation was given to sites outside of the prostate bed or pelvic lymph nodes that are typically treated in the salvage or adjuvant radiation setting.
Treatment with orchiectomy or abiraterone is allowed if testosterone has recovered to above 150 ng/dL.