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Metastatic Prostate CancerPhase 2DIRECTNCT05404139

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

A Phase 2 study testing Abiraterone and Atorvastatin in people with Metastatic Prostate Cancer, run by University Health Network, Toronto at 2 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 100 years, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
Abiraterone and Atorvastatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
2 sitesCanada
Study dates
24 May 2023to Feb 2031
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT
  • 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
  • ALT/AST > 3 x ULN
  • History of myasthenia gravis or active myasthenia gravis
  • History of ocular myasthenia or active ocular myasthenia

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel Glicksman, MD contact

416-946-4961

rachel.glicksman@uhn.ca

Canada2 sites, 1 recruiting

  • Princess Margaret Cancer Center

    Toronto, Ontario, M5G 2M9

    Rachel Glicksman, MD, 416-946-4501 ext. 4483, rachel.glicksman@uhn.ca

    Recruiting

  • Sunnybrook Research Institute

    Toronto, Ontartio, M4N 3M5

    Active, not recruiting

Other trials in Canada

About this study

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

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.

Being tested
Abiraterone, Standard of Care SBRT and ADT, Atorvastatin
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbirateroneDrug

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

  • Standard of Care SBRT and ADTOther

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

  • AtorvastatinDrug

    Lipid metabolism regulator

Study groups in NCT05404139
Study groupRoleWhat they receive
Arm 1 - Standard of CareOtherParticipants in this group will receive standard of care radiation treatment and ADT. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 3-4 months as per standard of care (for 8-9 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.).
Receives: Other: Standard of Care SBRT and ADT
Arm 3 - Study Treatment (Abiraterone)ExperimentalParticipants in this group will receive standard of care radiation treatment and ADT, plus abiraterone. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 3-4 months as per standard of care (for 8-9 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.). In addition, participants will take abiraterone orally (by mouth) daily for 8-9 months. Participants will start the first pill within a month of enrollment. This pill can be taken around the same time of day with or without food.
Receives: Drug: Abiraterone; Other: Standard of Care SBRT and ADT
Arm 4: Study Treatment (Abiraterone + Atorvastatin)ExperimentalParticipants in this group will receive standard of care radiation treatment and ADT, plus abiraterone and atorvastatin. Participants will start ADT first. Androgen deprivation therapy will be delivered via injection every 3 or 4 months as per standard of care (for 8-9 months total). At the same time, or within 3 months of starting ADT, participants will begin radiation treatment. The radiation treatment course will consist of 2-5 sessions of radiation daily or every other day (the number of sessions will be determined by the physician depending on the location of cancer, number of cancer spots, etc.). In addition, participants will take abiraterone orally (by mouth) daily for 8-9 months. Participants will start the first pill within a month of enrollment. This pill can be taken around the same time of day with or without food. Participants will also take atorvastatin once daily by mouth for 2 years. This may also be taken with or without food.
Receives: Drug: Abiraterone; Other: Standard of Care SBRT and ADT; Drug: Atorvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    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.

    Measured: 5 years

Secondary outcomes (6)

  1. Patient-reported quality of life

    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).

    Measured: 5 years

  2. Patient-reported quality of life

    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).

    Measured: 5 years

  3. Physician-reported toxicity

    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.

    Measured: 5 years

  4. Time to Testosterone Recovery

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

    Measured: 5 years

  5. Improvement in Metabolic Parameters

    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.

    Measured: 5 years

  6. Circulating Cell-Free DNA

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2022
  2. Study start24 May 2023
  3. Primary completionFeb 2031 (estimated)
  4. Study completionFeb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
352 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05404139
Sponsor's protocol ID
22-5274
Acronym
DIRECT
Status last verified
Jul 2026
First submitted
19 May 2022
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Abiraterone and Atorvastatin in people with Metastatic Prostate Cancer, run by University Health Network, Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel Glicksman, MD (416-946-4961, rachel.glicksman@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05404139.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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