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NCT Number: NCT05404139

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

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.

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Key information

Conditions

Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Cancer Center, Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abiraterone

Drug

Second-generation androgen pathway inhibitor (ARAT), oral tablet

Standard of Care SBRT and ADT

Other

Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)

atorvastatin

Drug

Lipid metabolism regulator

Primary outcomes

  1. Progression free survival

    Time frame: 5 years

    Determine if progression free survival improves with the addition of short-term ARPI (abiraterone or abiraterone) with or without statin (atorvastatin) to standard of care treatment.

Secondary outcomes

  1. Patient-reported quality of life

    Time frame: 5 years

    Determine if the addition of short-term ARPI (abiraterone or enzalutamide) with or without statin (atorvastatin) to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (FACT-P).

  2. Patient-reported quality of life

    Time frame: 5 years

    Determine if the addition of short-term ARPI (abiraterone or enzalutamide) with or without statin (atorvastatin) to standard of care treatment results in a patient-reported quality of life difference compared to standard of care treatment alone using quality of life questionnaires (FACT-Fatigue).

  3. Physician-reported toxicity

    Time frame: 5 years

    Determine if the addition of short-term ARPI (abiraterone or enzalutamide) with or without statin (atorvastatin) to standard of care treatment results in a physician-reported difference in acute and late toxicities compared to standard of care treatment alone assessed by CTCAE Toxicity 5.0.

  4. Time to Testosterone Recovery

    Time frame: 5 years

    Determine time to testosterone recovery with the use of standard of care treatment, with or without ARPI (abiraterone or enzalutamide).

  5. Improvement in Metabolic Parameters

    Time frame: 5 years

    Determine if a statin (atorvastatin) with short-term ARPI (abiraterone) and standard of care treatment results in improved metabolic parameters (e.g. lipid profile, fasting glucose) and lower occurrence of cardiovascular events compared to short-term ARPI and standard of care treatment, alone.

  6. Circulating Cell-Free DNA

    Time frame: 2 years

    Determine if a statin (atorvastatin) with short-term ARPI (abiraterone) and standard of care treatment results in lower levels of circulating cell-free DNA compared to short-term ARPI and standard of care treatment, alone.

Study contacts

Contact information is provided by the study sponsor or research team.

Rachel Glicksman, MD

CONTACT

[email protected]

416-946-4961

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Astellas Pharma Inc

Registry information

Official study title

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

Acronym: DIRECT

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Jun 3, 2022
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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