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Recruiting NCT05404139

Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

Phase II Interventional Metastatic Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abiraterone, Standard of Care SBRT and ADT, Atorvastatin.
Who it may be relevant to
Registry conditions: Metastatic Prostate Cancer. Basic parameters: 18 years — 100 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate

Overview

This is a multi-centre, investigator-initiated, three-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor and atorvastatin to standard of care radiation and hormone therapy improve quality of life. Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1), standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months plus atorvastatin for 2 years (Arm 4). Participants will be routinely follow-up in clinic or remotely for up to 5 years.

Interventions

  • Drug Abiraterone
    Second-generation androgen pathway inhibitor (ARAT), oral tablet
  • Other Standard of Care SBRT and ADT
    Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)
  • Drug Atorvastatin
    Lipid metabolism regulator

Primary outcome measures

  • Progression free survival [Time frame: 5 years]
Secondary outcome measures (6)
  • Patient-reported quality of life [Time frame: 5 years]
  • Patient-reported quality of life [Time frame: 5 years]
  • Physician-reported toxicity [Time frame: 5 years]
  • Time to Testosterone Recovery [Time frame: 5 years]
  • Improvement in Metabolic Parameters [Time frame: 5 years]
  • Circulating Cell-Free DNA [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Age > 18 years
  • Able to provide informed consent
  • Histologic diagnosis of prostate adenocarcinoma
  • ECOG performance status 0-2
  • Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases
  • Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)
  • Additional metastases can be detectable by PSMA PET only
  • All sites of disease are amenable to and can be safely treated with radiotherapy
  • Patients decline continuous use of ADT

Exclusion Criteria (for all patients):

  • Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT

a. Patients with significant comorbidities rendering patient not suitable for atorvastatin is not an exclusion criteria, as these patients can still enroll and be randomized between Arms 1 and 3.

  • History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
  • Prior use of salvage systemic therapy
  • Evidence of spinal cord compression

Exclusion Criteria (for Arm 4 only, after randomization)

  • ALT/AST > 3 x ULN
  • History of myasthenia gravis or active myasthenia gravis
  • History of ocular myasthenia or active ocular myasthenia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 2 centers
  • Princess Margaret Cancer Center — Toronto
  • Sunnybrook Research Institute — Toronto

Identifiers

NCT: NCT05404139 · 22-5274

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗