Metastatic Hormone Naive Prostate CancerPhase 2UpFrontPSMANCT04343885
In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy
A Phase 2 study testing 177Lu-PSMA-617 and Docetaxel in people with Metastatic Hormone Naive Prostate Cancer, run by Peter MacCallum Cancer Centre, Australia at 12 sites in Australia.
Trial summary
This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Hormone Naive Prostate Cancer
- What is being tested?
- 177Lu-PSMA-617 and Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 12 sitesAustralia
- Study dates
- 21 Apr 2020to Mar 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
- Patient has provided written informed consent
- Male aged 18 years or older at screening
- Prostate cancer diagnosed within 12 weeks of commencement of screening
- Histologically or cytologically confirmed adenocarcinoma of the prostate without significant neuroendocrine differentiation or small cell histology OR metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) with a rising serum PSA
- Evidence of metastatic disease on CT and/or bone scan
- PSA > 10ng/ml prior to commencement of medical ADT or surgical orchidectomy
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- Adequate haematological, renal and hepatic functions as defined by:
- Absolute neutrophil count >1.5 x 109/L
- Platelet count >100 x 109/L
- Haemoglobin ≥ 90g/L (no red blood cell transfusion in 4 weeks prior to randomisation)
- Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)
- Total bilirubin < 1.5 x ULN (unless known or suspected Gilbert syndrome)
- Aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 2.0 x ULN (or ≤ 5.0 x ULN in the presence of liver metastases)
- Have a performance status of 0-2 on the ECOG Performance Scale (see Appendix 1)
- Life expectancy greater than 6 months with treatment
- Assessed by a medical oncologist as suitable for treatment with docetaxel
- Patients must agree to use an adequate method of contraception
- Willing and able to comply with all study requirements, including all treatments and required assessments including follow-up
- Significant PSMA avidity on 68Ga-PSMA PET/CT, defined after central review as a minimum uptake of SUVmax 15 at a site of disease
- High-volume metastatic disease on 68Ga-PSMA PET/CT defined as visceral metastases or ≥ 4 bone metastases with ≥ 1 outside the vertebral column and pelvis (extra-axial skeleton)
- Patient continues to meet all the inclusion criteria for registration
Who cannot join
- Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer. The following exceptions are permitted:
- Up to 4 weeks of ADT with luteinising hormone releasing hormone agonists or antagonists or orchiectomy ± concurrent anti-androgens are permitted prior to commencement of screening. At investigator discretion, patients may start ADT at commencement of protocol therapy
- Up to one course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 14 days prior to registration
- Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
- Central nervous system metastases
- Patients with Sjogren's syndrome
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- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
- Prior diagnosis of another cancer that was:
- More than 3 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence greater than 10%
- Within 3 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or adequately treated non-muscle invasive bladder cancer (Tis, Ta and low grade T1 tumours)
- Major FDG-PET discordance defined as presence of FDG positive disease with minimal PSMA expression in multiple sites (>5) or in more than 50% of total disease volume
- All the exclusion criteria for registration continue to not apply
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Australia12 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Liverpool Hospital
Liverpool, New South Wales, 2170
Cabrini Hospital
Malvern, Victoria, 3144
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Austin Health
Melbourne, Victoria, 3084
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Alfred Hospital
Prahran, Victoria, 3000
Royal North Shore
St Leonards, New South Wales, 2065
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010
Chris O'Brien Lifehouse
Sydney, New South Wales, 2050
About this study
Official title: UpFrontPSMA : A Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer
This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).
Read the detailed description
This is an open label, randomised, stratified, 2-Arm, multi-centre, phase 2 clinical trial recruiting 140 newly-diagnosed high-volume mHNPC patients at 11 Australian centres over a period of 18 months. Patients will be randomised to the experimental Arm (177Lu-PSMA followed by docetaxel) or standard-of-care Arm (docetaxel) in a 1:1 ratio. All patients will receive ADT continuously throughout the trial. Patients will be stratified according to disease volume by conventional imaging (low-volume vs. high-volume) and duration of ADT at time of registration (≤ 28 days vs. > 28 days).
- Conditions
- Metastatic Hormone Naive Prostate Cancer
- Being tested
- 177Lu-PSMA-617, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
177Lu-PSMA-617Drug
Also called 177Lu-PSMA-617 also referred to as 177Lu-PSMA
Patients will be given 7.5GBq of 177Lu-PSMA every 6 weeks for 2 cycles.
DocetaxelDrug
Also called Taxotere (trade name)
Docetaxel 75 mg/m2 given every 3 weeks for 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-PSMA+ Docetaxel | Experimental | 7.5 GBq (± 10%) 177Lu-PSMA every 6 weeks x 2 cycles. Docetaxel 75 mg/m2 commencing 6 weeks later, every 3 weeks x 6 cycles Receives: Drug: 177Lu-PSMA-617; Drug: Docetaxel |
| Docetaxel (Control) | Other | Docetaxel 75 mg/m2 every 3 weeks x 6 cycles Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy
Undetectable PSA is defined as PSA ≤ 0.2ng/ml at 12 months after protocol treatment commencement. Patients who experience unequivocal radiographic (by conventional imaging modality) and/or clinical disease progression within 12 months of initiating protocol treatment will be considered as not having undetectable PSA at 12 months.
Measured: Upto 32 months assuming 18 months to complete recruitment, a maximum of 1.6 months from consent to commencement of treatment for last patient and then 12 months from commencement of treatment for last patient.
Secondary outcomes (8)
Safety of 177Lu-PSMA followed by docetaxel compared to docetaxel alone
The type, grade and relationship to treatment of adverse events (AE) will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0
Measured: Through completion of treatment, maximum 26 months.
Time to development of castration resistance between treatment Arms
Castration resistance is defined as rising PSA and/or radiographic progression despite castrate levels of testosterone (≤ 50ng/dL or ≤ 1.73nmol/L).To be measured from the date of randomisation to the date of first evidence of castration resistance.
Measured: Through study completion, up until 2 years after the last patient commences treatment.
PSA-progression free survival (PSA-PFS) between treatment Arms
PSA progression is defined as a rise in PSA by more than 25% AND more than 2ng/mL above the nadir (lowest PSA point). This needs to be confirmed by a repeat PSA performed at least 3 weeks later. Early rises in PSA prior to 12 weeks will be disregarded in determining PSA progression. To be measured from the date of randomisation to the first date of evidence of PSA progression or date of death due to any cause.
Measured: Through study completion, up until 2 years after the last patient commences treatment.
Radiographic-PFS (rPFS) between treatment Arms
Radiographic progression will be assessed by the investigator per RECIST1.1 for soft tissue and PCWG3 for bone lesions. To be measured from randomisation to the first date of documented radiographic progression using conventional imaging or death due to any cause, whichever occurs first.
Measured: Through study completion, up until 2 years after the last patient commences treatment.
Early PSMA PET response between treatment Arms
PSMA PET response assessed 3 months after treatment commencement defined by central imaging review of 68Ga-PSMA PET CT images.
Measured: Through completion of 3 months after treatment commencement for last patient, maximum 23 months.
Describe and compare health-related QoL within 12 months of treatment commencement between treatment Arms
QoL will be assessed using the Functional Assessment of Cancer Therapy for Prostate Cancer (FACT-P) questionnaire. The primary endpoint for QoL is the area under the curve (AUC) of the trial outcome index (TOI).
QoL will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months and will be scored according to the respective manuals.
Measured: Through completion of 12 months after treatment commencement of last patient, maximum 32 months.
Describe and compare pain within 12 months of treatment commencement between treatment Arms
Pain will be assessed using the Brief Pain Inventory - Short Form (BPI-SF). The primary endpoint for pain is the area under the curve (AUC) of the worst pain in 24h.
Pain and QoL will be assessed at baseline, 6 weeks, 3 months, 6 months, 9 months and 12 months and will be scored according to the respective manuals.
Measured: Through completion of 12 months after treatment commencement of last patient, maximum 32 months.
Overall survival (OS) between treatment Arms
OS is defined as the time from randomisation to the date of death due to any cause.
Measured: Through study completion, up until 2 years after the last patient commences treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start21 Apr 2020
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Hormone Naive Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- Movember Foundation, Prostate Cancer Research Alliance, United States Department of Defense, Advanced Accelerator Applications, Australia's Nuclear Science and Technology Organisation (ANSTO), Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Australasian Radiopharmaceutical Trials network (ARTnet), Centre for Biostatistics and Clinical Trials (BaCT)
- Responsible party
- Sponsor
- Investigators
- Arun Azad, MBBS PhD FRACP, Principal investigator, Peter MacCallum Cancer Centre, AustraliaMichael Hofman, MBBS(Hons),FRACP,FAANMS,FICIS, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343885
- Sponsor's protocol ID
- 19/195
- Acronym
- UpFrontPSMA
- Status last verified
- Jul 2025
- First submitted
- 1 Apr 2020
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azad AA, Bressel M, Tan H, Voskoboynik M, Suder A, Weickhardt AJ, Guminski A, Francis RJ, Saghebi J, Dhiantravan N, Joshua AM, Emmett L, Horvath L, Murphy DG, Hsiao E, Balakrishnar B, Lin P, Redfern A, Macdonald W, Ng S, Lee ST, Pattison DA, Nadebaum D, Kirkwood ID, Hofman MS; UpFrontPSMA Study Team. Sequential [177Lu]Lu-PSMA-617 and docetaxel versus docetaxel in patients with metastatic hormone-sensitive prostate cancer (UpFrontPSMA): a multicentre, open-label, randomised, phase 2 study. Lancet Oncol. 2024 Oct;25(10):1267-1276. doi: 10.1016/S1470-2045(24)00440-6. Epub 2024 Sep 15.
PubMed 39293461
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UpFrontPSMA : A Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer
- ClinicalTrials.gov ID
- NCT04343885
- Acronym / sponsor ID
- UpFrontPSMA / 19/195
- Conditions
- Metastatic Hormone Naive Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Collaborators
- Movember Foundation, Prostate Cancer Research Alliance, United States Department of Defense, Advanced Accelerator Applications, Australia's Nuclear Science and Technology Organisation (ANSTO), Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Australasian Radiopharmaceutical Trials network (ARTnet), Centre for Biostatistics and Clinical Trials (BaCT)
- Study start
- 21 Apr 2020 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 2 randomised clinical trial will compare the effectiveness of Lu-PSMA therapy followed by docetaxel chemotherapy versus docetaxel chemotherapy on its own in patients with newly-diagnosed high-volume metastatic hormone-naive prostate cancer (mHNPC).
Detailed description
This is an open label, randomised, stratified, 2-Arm, multi-centre, phase 2 clinical trial recruiting 140 newly-diagnosed high-volume mHNPC patients at 11 Australian centres over a period of 18 months. Patients will be randomised to the experimental Arm (177Lu-PSMA followed by docetaxel) or standard-of-care Arm (docetaxel) in a 1:1 ratio. All patients will receive ADT continuously throughout the trial. Patients will be stratified according to disease volume by conventional imaging (low-volume vs. high-volume) and duration of ADT at time of registration (≤ 28 days vs. > 28 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 177Lu-PSMA+ Docetaxel | Experimental | Drug: 177Lu-PSMA-617, Drug: Docetaxel7.5 GBq (± 10%) 177Lu-PSMA every 6 weeks x 2 cycles. Docetaxel 75 mg/m2 commencing 6 weeks later, every 3 weeks x 6 cycles |
| Docetaxel (Control) | Other | Drug: DocetaxelDocetaxel 75 mg/m2 every 3 weeks x 6 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patient has provided written informed consent
- Male aged 18 years or older at screening
- Prostate cancer diagnosed within 12 weeks of commencement of screening
- Histologically or cytologically confirmed adenocarcinoma of the prostate without significant neuroendocrine differentiation or small cell histology OR metastatic disease typical of prostate cancer (i.e. involving bone or pelvic lymph nodes or para-aortic lymph nodes) with a rising serum PSA
- Evidence of metastatic disease on CT and/or bone scan
Key exclusion criteria (12 listed)
- Any prior pharmacotherapy, radiation therapy, or surgery for metastatic prostate cancer. The following exceptions are permitted:
- Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression
- Central nervous system metastases
- Patients with Sjogren's syndrome
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 177Lu-PSMA-617Also: 177Lu-PSMA-617 also referred to as 177Lu-PSMAPatients will be given 7.5GBq of 177Lu-PSMA every 6 weeks for 2 cycles. | Drug | 177Lu-PSMA+ Docetaxel |
| DocetaxelAlso: Taxotere (trade name)Docetaxel 75 mg/m2 given every 3 weeks for 6 cycles | Drug | 177Lu-PSMA+ Docetaxel, Docetaxel (Control) |
Primary outcome
Undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy
Time frame: Upto 32 months assuming 18 months to complete recruitment, a maximum of 1.6 months from consent to commencement of treatment for last patient and then 12 months from commencement of treatment for last patient.
Undetectable PSA is defined as PSA ≤ 0.2ng/ml at 12 months after protocol treatment commencement. Patients who experience unequivocal radiographic (by conventional imaging modality) and/or clinical disease progression within 12 months of initiating protocol treatment will be considered as not having undetectable PSA at 12 months.
8 secondary outcomes
Safety of 177Lu-PSMA followed by docetaxel compared to docetaxel alone
Time frame: Through completion of treatment, maximum 26 months.
Time to development of castration resistance between treatment Arms
Time frame: Through study completion, up until 2 years after the last patient commences treatment.
PSA-progression free survival (PSA-PFS) between treatment Arms
Time frame: Through study completion, up until 2 years after the last patient commences treatment.
Radiographic-PFS (rPFS) between treatment Arms
Time frame: Through study completion, up until 2 years after the last patient commences treatment.
Early PSMA PET response between treatment Arms
Time frame: Through completion of 3 months after treatment commencement for last patient, maximum 23 months.
Describe and compare health-related QoL within 12 months of treatment commencement between treatment Arms
Time frame: Through completion of 12 months after treatment commencement of last patient, maximum 32 months.
Describe and compare pain within 12 months of treatment commencement between treatment Arms
Time frame: Through completion of 12 months after treatment commencement of last patient, maximum 32 months.
Overall survival (OS) between treatment Arms
Time frame: Through study completion, up until 2 years after the last patient commences treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Derived from this study: PubMed 39293461Azad AA, Bressel M, Tan H, Voskoboynik M, Suder A, Weickhardt AJ, Guminski A, Francis RJ, Saghebi J, Dhiantravan N, Joshua AM, Emmett L, Horvath L, Murphy DG, Hsiao E, Balakrishnar B, Lin P, Redfern A, Macdonald W, Ng S, Lee ST, Pattison DA, Nadebaum D, Kirkwood ID, Hofman MS; UpFrontPSMA Study Team. Sequential [177Lu]Lu-PSMA-617 and docetaxel versus docetaxel in patients with metastatic hormone-sensitive prostate cancer (UpFrontPSMA): a multicentre, open-label, randomised, phase 2 study. Lancet Oncol. 2024 Oct;25(10):1267-1276. doi: 10.1016/S1470-2045(24)00440-6. Epub 2024 Sep 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Azad, MBBS PhD FRACP principal investigator
Peter MacCallum Cancer Centre, Australia
Michael Hofman, MBBS(Hons),FRACP,FAANMS,FICIS principal investigator
Peter MacCallum Cancer Centre, Australia
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 177Lu-PSMA-617 and Docetaxel in people with Metastatic Hormone Naive Prostate Cancer, run by Peter MacCallum Cancer Centre, Australia at 12 sites in Australia.
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 21 inclusion and 12 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia. 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?
Undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy (time frame: Upto 32 months assuming 18 months to complete recruitment, a maximum of 1.6 months from consent to commencement of treatment for last patient and then 12 months from commencement of treatment for last patient.). 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 NCT04343885, which also lists 1 linked publication.
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 11 Jul 2025.