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Androgen Receptor Antagonist

Androgen Deprivation Therapy for Prostate Cancer (ADDItion Trial)

Phase 1 & 2
Waitlist Available
Led By David VanderWeele, MD\Phd
Research Sponsored by David VanderWeele
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 from c1d1 until death or up to a maximum of 24 months
Awards & highlights

ADDItion Trial Summary

This study is evaluating whether ipatasertib can be safely combined with darolutamide in patients with castration resistant prostate cancer.

Eligible Conditions
  • Prostate Cancer

ADDItion Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from c1d1 until death or up to a maximum of 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from c1d1 until death or up to a maximum of 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase II: Pathological Complete Response (pCR) Rate
Secondary outcome measures
Phase II - Two Year Biochemical Recurrence-free Survival
Phase II: Rate of PSA0
Summary of Dose-Limiting Toxicities

Side effects data

From 2016 Phase 2 trial • 102 Patients • NCT00776594
64%
Hot flashes
58%
Fatigue
42%
Head/headache
29%
Hypertension
23%
Nose- hemorrhage
23%
Joint- pain
23%
Urinary frequency/urgency
17%
Neuropathy-sensory
15%
Voice changes/dysarthria
14%
Extremity-limb- pain
14%
Constipation
11%
Proteinuria
11%
Insomnia
9%
Muscle- pain
9%
Dry skin
9%
Creatinine
9%
Pain-other
8%
Hypertriglyceridemia
8%
Pulmonary/Upper Respiratory-other
8%
Skin-other
8%
Cough
8%
Diarrhea w/o prior colostomy
8%
AST- SGOT
8%
Dizziness
8%
Back- pain
6%
Hypercholesterolemia
6%
Arthritis
6%
Allergic rhinitis
6%
Oral cavity- hemorrhage
6%
Edema limb
6%
ALT- SGPT
5%
Hyperkalemia
5%
Platelets
5%
Hemoglobin
5%
Sweating
5%
Constitutional- other
5%
Injection site reaction
5%
Anorexia
5%
Incontinence urinary
3%
Neck- pain
3%
Nonneuropathic generalized weakness
3%
Chest wall- pain
3%
Neurologic-other
3%
Hyponatremia
3%
Muco/stomatitis (symptom) oral cavity
3%
Infection Gr0-2 neut- sinus
3%
Cognitive disturbance
3%
Chest/thoracic pain NOS
3%
Hyperglycemia
3%
Dyspnea
3%
Hypokalemia
3%
Lymphopenia
3%
Fever w/o neutropenia
3%
Weight loss
3%
Pruritus/itching
3%
Rash/desquamation
3%
Muco/stomatitis by exam- oral cavity
3%
Nausea
3%
Taste disturbance
3%
GI-other
3%
Lower GI- hemorrhage NOS
3%
Urinary hemorrhage NOS
3%
Infection-other
3%
Joint-function
3%
Agitation
3%
Depression
3%
Abdomen- pain
3%
Renal/GU-other
2%
Neuropathy CN IX pharynx ear tongue
2%
Vomiting
2%
Nonneuropathic upper extr muscle weak
2%
Bronchospasm- wheezing
2%
Erectile impotence
2%
Infection w/ unk ANC ungual (nails)
2%
Obstruction- airway-bronchus
2%
Musculoskeletal/soft tissue-other
2%
Infection w/ unk ANC peritoneal cavity
2%
Extremity upper (function)
2%
Infection w/ unk ANC oral cavity/gums
2%
Hemoglobinuria
2%
Infection Gr0-2 neut- oral cavity
2%
Cardiac-ischemia
2%
Sinus bradycardia
2%
Infection w/ unk ANC sinus
2%
Infection Gr0-2 neut- urinary tract
2%
Infection w/ unk ANC urinary tract NOS
2%
Hyopthyroidism
2%
Muco/stomatitis by exam- larynx
2%
Infection Gr0-2 neut- bronchus
2%
Infection Gr0-2 neut- upper airway
2%
Alkaline phosphatase
2%
Arrhythmia-other
2%
Gastritis
2%
Ataxia
2%
Syncope
2%
Scalp- pain
2%
Endocrine-other
2%
Muco/stomatitis (symptom) stomach
2%
Hemorrhage-other
2%
Oral cavity- pain
2%
Fistula- Anus
2%
Flatulence
2%
Scrotum- pain
2%
Throat/pharynx/larynx- pain
2%
Bone marrow cellularity
2%
Rigors/chills
2%
Bruising
2%
Alopecia
2%
Hyperpigmentation
2%
Rash: acne/acneiform
2%
Dentures or dental prosthesis
2%
Dry mouth
2%
Dysphagia
2%
Esophagitis
2%
Hemorrhoids
2%
Incontinence- anal
2%
Salivary
2%
Ulcer- duodenum
2%
Rectum- hemorrhage
2%
Bladder- hemorrhage
2%
Edema head and neck
2%
Lymphatics-other
2%
Bilirubin
2%
Nonneuropathic lower extr muscle weak
2%
Confusion
2%
Memory impairment
2%
Anxiety
2%
Neuropathy CN II vision
2%
Vision-blurred
2%
Ocular-other
2%
Anus- pain
2%
Buttock- pain
2%
Neuropathic- pain
2%
Nasal cavity/paranasal sinus reaction
2%
Urinary retention
2%
Intra-op injury Face NOS
2%
Allergy-other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1
Group 2

ADDItion Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase II: ADT + Ipatasertib + DarolutamideExperimental Treatment3 Interventions
All Cycles: Ipatasertib + Darolutamide + ADT
Group II: Phase I De-Escalation Cohort: ADT + Ipatasertib + DarolutamideExperimental Treatment3 Interventions
Cycle 0 Days 1-7: Ipatasertib Monotherapy + Androgen Deprivation Therapy (ADT) Cycle 1+: Ipatasertib + Darolutamid + ADT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Androgen Deprivation Therapy
2008
Completed Phase 2
~110
Ipatasertib
2011
Completed Phase 3
~2320
Darolutamide
2018
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

David VanderWeeleLead Sponsor
David VanderWeele, MD\Phd5.02 ReviewsPrincipal Investigator - Northwestern University
Big Ten Cancer Research Consortium
5Patient Review
This doctor was able to explain my situation to me clearly and I could tell that they really knew what they were talking about. They had a great depth of knowledge and understanding.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer
David VanderWeele 2021. "Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04737109.
~2 spots leftby Apr 2025
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