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Prostate CancerPhase 2NCT04663997

177 LuPSMA-617 vs Docetaxel in Metastatic Castration Resistant and PSMA-Positive Prostate Cancer

A Phase 2 study testing 177Lu-PSMA-617 and Docetaxel in people with Prostate Cancer, run by Canadian Cancer Trials Group at 10 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

177Lu PSMA 617 is a new type of therapy which is designed to deliver high doses of radiation directly to prostate cancer sites in the body. The purpose of this study is to find out whether 177Lu PSMA 617can slow the growth of prostate cancer compared to standard chemotherapy treatment Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
177Lu-PSMA-617 and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
10 sitesCanada
Study dates
11 Aug 2021to 31 Dec 2026
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological evidence of prostate cancer with no evidence of small cell component
  • Patients must have castration resistance and metastatic disease with evidence of biochemical or imaging progression in the setting of surgical/medical castration
  • Progression on treatment with abiraterone and/or enzalutamide, or similar next-generation androgen receptor (AR) targeted therapy
  • Evidence of PSMA positive metastatic disease, as assessed on PSMA-PET imaging studies obtained as part of other clinical trial protocols are mandated, provided they are obtained within a timeframe that meets the requirements of this study. The radiopharmaceuticals must be based on a lysine-urea-glutamate backbone, with a 18F or 68Ga radionuclide label.
  • Prior orchiectomy, or if on LHRH agonist/antagonist then testosterone < 1.7 nmol/L
  • Adequate organ function
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  • Recover from all previous cancer treatment toxicities to grade ≤ 2 (as per CTCAE v5.0)
  • Male subject ≥ 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Who cannot join

  • Prior treatment with chemotherapy for castration-resistant disease or prior chemotherapy in the castration-sensitive (hormone-sensitive) setting ≤ 1 year prior to enrollment.
  • Prior treatment with 177Lu-PSMA (including other radiolabeled therapeutic PSMA-ligands) or radio-immunotherapy. Prior treatment with radium-223 is allowed but requires a minimum of a 6-month interval between the last dose of radium-223 and enrollment.
  • Radiotherapy to target lesions (measurable disease) ≤ 12 weeks prior to enrolment.
  • Presence of majority (> 50% of extra-osseous lesions) or large (> 5 cm) soft tissue lesions that are negative on PSMA-Ligand PET/CT or PSMA-Ligand PET/MR
  • Known parenchymal brain metastases
  • Active epidural disease (treated epidural disease is permitted)
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  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Clinically significant cardiac disease
  • Major surgery within 4 weeks of starting study treatment
  • Patients with a history of hypersensitivity to the study drug or components
  • Patients with a clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or sever psychiatric illness/social situations.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

Canada10 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Hotel-Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • CIUSSS de l'Estrie - Centre hospitalier

    Sherbrooke, Quebec, J1H 5N4

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Randomized Phase II Study of 177 LuPSMA-617 vs Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease

177Lu PSMA 617 is a new type of therapy which is designed to deliver high doses of radiation directly to prostate cancer sites in the body. The purpose of this study is to find out whether 177Lu PSMA 617can slow the growth of prostate cancer compared to standard chemotherapy treatment

Read the detailed description

The standard or usual treatment for this disease is a chemotherapy drug called docetaxel, given by intravenous every 3 weeks, for up to 12 treatments.

177Lu-PSMA-617 is a new type of therapy for prostate cancer. Laboratory tests show that it may help slow the growth of prostate cancer. 177Lu-PSMA-617 has been shown to shrink tumours in animals and has been studied in limited numbers of men with prostate cancer and seems promising but it is not clear if it can offer better control of prostate cancer compared to docetaxel chemotherapy .

Conditions
Prostate Cancer
Being tested
177Lu-PSMA-617, Docetaxel
Keywords
mCRPC, docetaxel, 177Lu-PSMA-617, radioligand therapy, metastatic prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • 177Lu-PSMA-617Drug

    IA of 7.4GBq (± 10%) IV every 6 weeks; maximum 6 cycles

  • DocetaxelDrug

    75mg/m2 IV every 3 weeks maximum 12 cycles

Study groups in NCT04663997
Study groupRoleWhat they receive
177 Lu-PSMA-617ExperimentalNot described
Receives: Drug: 177Lu-PSMA-617
DocetaxelActive comparatorNot described
Receives: Drug: Docetaxel

What is being measured

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

  1. Progression-free survival

    Measured: 3 years

Secondary outcomes (10)

  1. Progression-free survival rate at 6 months defined by PSA

    Measured: 6 months

  2. Progression-free survival rate at 6 months defined by PCWG 3

    Measured: 6 months

  3. Progression-free survival rate at 6 months defined by RECIST 1.1

    Measured: 6 months

  4. Second rPFS in patients who meet the criteria for rPFS and cross over to the alternate therapy

    Measured: 3 years

  5. Time to commencement of third line therapy

    Measured: 3 years

  6. Overall Survival

    Measured: 3 years

  7. Proportions of patients with decreased PSA from baseline and the magnitude of change

    e.g. ≥ 30%, ≥ 50%, ≥ 90% decline from baseline

    Measured: 3 years

  8. Clinical benefit rate (CBR) > 24 weeks (RECIST v1.1).

    Measured: 3 years

  9. Response duration including partial response, complete response or stable disease > 24 (RECIST v1.1)

    Measured: 3 years

  10. Adverse event (AE) profile (CTCAE v5.0)

    Measured: 3 years

Timeline

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

  1. First posted11 Dec 2020
  2. Study start11 Aug 2021
  3. Primary completion25 Aug 2025
  4. Study completion31 Dec 2026 (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
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04663997
Sponsor's protocol ID
PR21
Status last verified
Oct 2025
First submitted
4 Dec 2020
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 177Lu-PSMA-617 and Docetaxel in people with Prostate Cancer, run by Canadian Cancer Trials Group at 10 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 11 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: 3 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 NCT04663997.

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 Mar 2026.

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