What side effects are associated with this type of intervention?

Common treatments for prostate cancer, such as PARP inhibitors like Olaparib, often cause side effects including anemia, nausea, fatigue, and anorexia. These side effects are generally manageable with dose modifications and supportive care. High-dose IV ascorbate, used to induce oxidative stress, may lead to gastrointestinal disturbances and potential kidney issues. Other common treatments, such as androgen deprivation therapy (ADT) and chemotherapy, can cause hot flashes, decreased libido, bone thinning, cardiovascular issues, and hematologic toxicities like neutropenia and thrombocytopenia. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Olaparib, a PARP inhibitor, has been approved by the FDA for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in patients with homologous recombination repair (HRR) gene mutations, such as BRCA1 and BRCA2. Other PARP inhibitors like rucaparib and niraparib have also shown efficacy in mCRPC with HRR mutations and are under study for broader approvals. While high-dose IV ascorbate is not yet FDA-approved for prostate cancer, it is being investigated for its potential to induce oxidative stress and enhance the efficacy of other treatments.

What other types of research exist?

Promising novel alternatives for prostate cancer treatment in 2024 include: 1) Lutetium-177-PSMA-617, a radioligand therapy targeting PSMA-positive metastatic CRPC, which has shown improved overall survival in clinical trials. 2) Bipolar Androgen Therapy (BAT), which involves cyclical high-dose testosterone therapy and has shown potential in resensitizing CRPC to androgen-directed therapies. 3) Pembrolizumab, an immune checkpoint inhibitor for patients with dMMR or high TMB tumors, offering a targeted immunotherapy option. These treatments represent significant advancements and offer new hope for patients with advanced prostate cancer.

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PARP Inhibitor

Olaparib + Vitamin C for Prostate Cancer

Phase 2

Recruiting

Led By Channing Paller, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of a drug that stops cancer cells from fixing themselves and high doses of vitamin C in prostate cancer patients who do not respond to standard hormone therapy and lack certain genetic mutations. The goal is to see if this combination can reduce cancer markers and improve survival.

Who is the study for?

Men over 18 with castration-resistant prostate cancer, who have progressed after one systemic treatment. They must have a PSA of at least 1 ng/mL, good performance status (able to carry out daily activities), and normal organ/marrow function. Contraception is required for men and their partners. Exclusions include prior PARP inhibitors use, recent major surgery or chemotherapy, strong CYP3A inducers use, uncontrolled heart conditions, active hepatitis or HIV.

What is being tested?

The trial tests the combination of Olaparib (a PARP inhibitor) and high-dose IV Vitamin C in treating prostate cancer without DNA repair gene mutations. It measures the reduction in PSA levels by half from baseline as the main outcome and looks at safety through incidence of severe toxicities.

What are the potential side effects?

Possible side effects may include nausea, fatigue, anemia (low red blood cell counts), potential kidney issues due to creatinine levels changes; allergic reactions are possible given it's a drug study but specific side effects will be monitored closely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PSA50 response

Secondary study objectives

Overall survival of patients with mCRPC receiving olaparib in combination with IV ascorbic acid

PSA doubling time in patients with mCRPC receiving olaparib in combination with IV ascorbic acid

PSA progression free survival (PSA PFS) of patients with mCRPC receiving olaparib in combination with IV ascorbic acid

+2 more

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195

49%

Nausea

47%

Fatigue

38%

Diarrhoea

29%

Abdominal pain

29%

Anaemia

28%

Constipation

27%

Decreased appetite

27%

Back pain

26%

Vomiting

21%

Arthralgia

19%

Pyrexia

18%

Asthenia

13%

Rash

13%

Nasopharyngitis

11%

Alanine aminotransferase increased

11%

Dyspnoea

10%

Neuropathy peripheral

10%

Cough

10%

Abdominal pain upper

10%

Dyspepsia

10%

Anxiety

10%

Pruritus

Dizziness

Hyperglycaemia

Aspartate aminotransferase increased

Thrombocytopenia

Oedema peripheral

Pain in extremity

Insomnia

Stomatitis

Dry mouth

Headache

Neutropenia

Blood creatinine increased

Weight decreased

Dysgeusia

Blood alkaline phosphatase increased

Neutrophil count decreased

Muscle spasms

Influenza

Influenza like illness

Myalgia

Peripheral sensory neuropathy

Gamma-glutamyltransferase increased

Hypertension

Platelet count decreased

Depression

Lymphopenia

Gastrooesophageal reflux disease

Abdominal distension

Musculoskeletal pain

Flank pain

Cholangitis

Flatulence

Paraesthesia

General physical health deterioration

Bladder papilloma

Pneumonia pneumococcal

Abdominal infection

Bartholinitis

Pneumonia

Cerebrovascular accident

Pneumothorax

Gastric varices haemorrhage

Large intestinal obstruction

Cholecystitis

Anastomotic haemorrhage

Device occlusion

Stent malfunction

Bronchiolitis

Empyema

Syncope

Incisional hernia

Device dislocation

Obstruction gastric

Cardiac failure

Vascular stenosis

Pleural effusion

Incarcerated inguinal hernia

Urinary tract infection

Hypothyroidism

Transient ischaemic attack

Infusion related reaction

Duodenal perforation

Melaena

Bile duct obstruction

Pancreatitis

100%

80%

60%

40%

20%

Study treatment Arm

Olaparib 300 mg Twice Daily (bd)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Olaparib and Vitamin CExperimental Treatment2 Interventions

Olaparib will be administered at 300 mg by mouth, twice daily; ascorbate will be administered at 1 g/kg IV twice weekly at least 24 hours apart, until objective disease progression or unacceptable toxicities or patient withdrawal for other reasons.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Vitamin C

2017

Completed Phase 4

~18470

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), androgen receptor antagonists, and PARP inhibitors like Olaparib. ADT reduces androgen levels, which prostate cancer cells rely on for growth. Androgen receptor antagonists, such as enzalutamide, block the androgen receptor signaling pathway, preventing cancer cell proliferation. PARP inhibitors, like Olaparib, target cancer cells with DNA repair deficiencies by inhibiting the PARP enzyme, leading to cell death. High-dose IV ascorbate induces oxidative stress, damaging cancer cell DNA. These treatments are crucial as they target specific mechanisms that prostate cancer cells depend on, offering tailored and effective therapeutic options.