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Advanced Prostate CarcinomaPhase 2DECREASENCT04319783

Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

A Phase 2 study testing Darolutamide and Radiotherapy in people with Advanced Prostate Carcinoma and Cancer of Prostate, run by Trans Tasman Radiation Oncology Group at 16 sites in 2 countries.

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

Darolutamide is a drug that has a proven survival benefit in non-metastatic (M0) castrate resistant prostate cancer when using conventional imaging. However, it is estimated that >90% of patients have disease apparent when using PSMA PET. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Darolutamide and Radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
16 sitesin 2 countries
Study dates
2 Jun 2021to Jun 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

  • ≥ 18 years of age and provided written Informed Consent
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Castration-resistant prostate cancer, defined as at least 2 consecutive PSA rises obtained at least 1 week apart in the setting of castrate testosterone levels
  • Castrate level of serum testosterone (<1.7 nmol/l [50 ng/dl]) on gonadotrophin - releasing hormone (GnRH) agonist or antagonist therapy or after bilateral orchiectomy
  • A baseline PSA level of at least 1ng per millilitre and a PSA doubling time of 10 months or less
  • Adequate bone marrow reserve and organ function Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Show all 10Show fewer
  • At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions; At least 1 site of PSMA-avid disease on PSMA-PET/CT imaging in any of the following regions:
  • Local recurrence within the prostate gland or prostate bed
  • Regional lymph node disease (below the aortic bifurcation)
  • Extra-pelvic lymph node, bone or soft tissue metastatic disease

Who cannot join

  • Patients with detectable metastases or a history of metastatic disease on conventional imaging
  • Prior treatment with second-generation androgen receptor (AR) antagonists, CYP17 enzyme inhibitors or oral ketoconazole
  • Use of oestrogens or 5-α reductase inhibitors or anti-androgens within 28 days before randomisation
  • Use of systemic corticosteroid with a dose greater than the equivalent 10 mg of prednisone/day within 28 days before randomisation
  • Radiotherapy within 12 weeks prior to randomisation
  • Initiation of treatment with an osteoclast-targeted therapy to prevent skeletal-related events within 12 weeks before randomisation
Show all 11Show fewer
  • Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV
  • Uncontrolled hypertension
  • Prior malignancy
  • Gastrointestinal disorder or procedure that expects to interfere significantly with the absorption of study treatment
  • Unable to swallow study medications and comply with study requirements

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

Australia15 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Peter MacCallum Cancer Centre, Bendigo

    Bendigo, Victoria, 3550

  • Peter MacCallum Cancer Centre, Box Hill

    Box Hill, Victoria, 3128

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2101

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4006

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • GenesisCare Hurstville

    Hurstville, New South Wales, 2220

  • Peter MacCallum Cancer Centre, Parkville

    Melbourne, Victoria, 3002

  • GenesisCare Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Princess Alexandra Hospital (ROPART)

    Raymond Terrace, Queensland, 4101

  • Icon Cancer Centre Epworth

    Richmond, Victoria, 3121

  • GenesisCare North Shore

    Saint Leonards, New South Wales, 2065

  • Western Health

    St Albans, Victoria, 3021

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Princess Alexandra Hospital (ROPAIR)

    Woolloongabba, Queensland, 4102

Other trials in Australia

Singapore1 site

  • National Cancer Centre Singapore

    Singapore, 168583

Other trials in Singapore

About this study

Darolutamide is a drug that has a proven survival benefit in non-metastatic (M0) castrate resistant prostate cancer when using conventional imaging. However, it is estimated that >90% of patients have disease apparent when using PSMA PET. This study investigates the use of local consolidation radiotherapy in this cohort of men.

Read the detailed description

This study explores the use of local consolidation therapy in the setting of Darolutamide in the initial diagnosis of metastatic castrate resistant prostate cancer (mCRPC). In the chemotherapy naïve mCRPC setting, the pattern of disease is of limited volume metastases (1-5) in 34%-40% of cases. As progression at known sites of macroscopic disease is the predominant cause of failure on systemic therapies, local consolidation therapy with stereotactic ablative body radiotherapy (SABR) may improve progression free survival (PFS) and overall survival (OS). This approach has been tested in the setting of lung cancer, in which consolidation SABR has resulted in OS benefit (HR of 0.40) in phase II studies. The novel approach of local consolidation therapy has not been tested as yet in mCRPC.

The secondary objective of this study proposal is to better understand the pattern of disease distribution at first diagnosis of CRPC. Previous studies have used conventional bone scan and CT imaging, and with these investigations the proportion of patients that are 'M0' is ~35%1. However, in the new era of PSMA PET, which is far more sensitive than conventional imaging, there exists a new group of men who are M0 on conventional imaging but are M1 on PSMA PET staging.

Thus, in the DECREASE study population, we expect the vast majority of patients with conventionally imaged 'M0 CRPC' will have disease detectable on PSMA PET scanning. In this context, the central hypothesis of this trial is that the addition of consolidation radiotherapy to darolutamide to PSMA detected sites of disease will improve the clinical outcome of patients compared to those patients receiving darolutamide alone.

Being tested
Darolutamide, Radiotherapy
Keywords
Darolutamide, Consolidation Radiotherapy, PSA, PSMA PET, Prostate Cancer, Advanced 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.

  • DarolutamideDrug

    Also called NUBEQA, Bayer HealthCare Pharmaceuticals Inc.

    Darolutamide alone

  • RadiotherapyRadiation

    Darolutamide + Consolidation Radiotherapy

Study groups in NCT04319783
Study groupRoleWhat they receive
DarolutamideExperimentalDarolutimide 600mg BD
Receives: Drug: Darolutamide
Local consolidation Radiotherapy + DarolutamideExperimentalDarolutimide 600mg BD + local consolidative radiotherapy, with a biological equivalent dose of 30Gy/10fx or greater if delivered with SABR. SABR is the preferred treatment approach, however conventional radiotherapy is acceptable. To up to 5 sites of disease
Receives: Drug: Darolutamide; Radiation: Radiotherapy

What is being measured

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

  1. Undetectable PSA at 12 months

    Undetectable PSA at 12 months

    Measured: 12 months

Secondary outcomes (6)

  1. Radiological progression free survival

    Radiological progression free survival

    Measured: 36 months

  2. Distribution of disease on baseline PSMA-PET/CT imaging

    Distribution of bone, nodal, visceral and recurrent primary disease on PSMA-PET/CT

    Measured: 36 months

  3. Biochemical progression free survival

    Biochemical progression free survival

    Measured: 36 months

  4. Treatment related adverse event

    Treatment related adverse events (CTCAE v 5.0)

    Measured: 36 months

  5. Overall survival

    Overall survival

    Measured: 36 months

  6. Patterns of disease on PSMA PET/CT after 12 weeks of commencing Darolutamide, and at time of disease progression

    PSMA avid disease at irradiated site / unirradiated site / bone / local / nodal / visceral

    Measured: 3 months

Timeline

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

  1. First posted24 Mar 2020
  2. Study start2 Jun 2021
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 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
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04319783
Sponsor's protocol ID
TROG 19.06
Other IDs
U1111-1242-9233
Acronym
DECREASE
Status last verified
Aug 2025
First submitted
9 Mar 2020
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Darolutamide and Radiotherapy in people with Advanced Prostate Carcinoma and Cancer of Prostate, run by Trans Tasman Radiation Oncology Group at 16 sites in 2 countries.

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 10 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 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Australia, Singapore. 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 PSA at 12 months (time frame: 12 months). 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 NCT04319783.

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 21 Aug 2025.

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