NCT04319783

Brief 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. This study investigates the use of local consolidation radiotherapy in this cohort of men.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for phase_2

Timeline
1mo left

Started Jun 2021

Longer than P75 for phase_2

Geographic Reach
2 countries

16 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2021Jun 2026

First Submitted

Initial submission to the registry

March 9, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

June 2, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

5 years

First QC Date

March 9, 2020

Last Update Submit

August 19, 2025

Conditions

Advanced Prostate CarcinomaCancer of ProstatePSACastrate Resistant Prostate Cancer

Keywords

DarolutamideConsolidation RadiotherapyPSAPSMA PETProstate CancerAdvanced Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Undetectable PSA at 12 months

    Undetectable PSA at 12 months

    12 months

Secondary Outcomes (6)

  • Radiological progression free survival

    36 months

  • Distribution of disease on baseline PSMA-PET/CT imaging

    36 months

  • Biochemical progression free survival

    36 months

  • Treatment related adverse event

    36 months

  • Overall survival

    36 months

  • +1 more secondary outcomes

Study Arms (2)

Darolutamide

EXPERIMENTAL

Darolutimide 600mg BD

Drug: Darolutamide

Local consolidation Radiotherapy + Darolutamide

EXPERIMENTAL

Darolutimide 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

Drug: DarolutamideRadiation: Radiotherapy

Interventions

DarolutamideDRUG

Darolutamide alone

Also known as: NUBEQA, Bayer HealthCare Pharmaceuticals Inc.
DarolutamideLocal consolidation Radiotherapy + Darolutamide
RadiotherapyRADIATION

Darolutamide + Consolidation Radiotherapy

Local consolidation Radiotherapy + Darolutamide

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCastration-resistant prostate cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

St Vincent's Hospital

Darlinghurst, New South Wales, 2101, Australia

Location

GenesisCare Hurstville

Hurstville, New South Wales, 2220, Australia

Location

GenesisCare North Shore

Saint Leonards, New South Wales, 2065, Australia

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4006, Australia

Location

Princess Alexandra Hospital (ROPART)

Raymond Terrace, Queensland, 4101, Australia

Location

Princess Alexandra Hospital (ROPAIR)

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Peter MacCallum Cancer Centre, Bendigo

Bendigo, Victoria, 3550, Australia

Location

Peter MacCallum Cancer Centre, Box Hill

Box Hill, Victoria, 3128, Australia

Location

Peter MacCallum Cancer Centre, Parkville

Melbourne, Victoria, 3002, Australia

Location

Icon Cancer Centre Epworth

Richmond, Victoria, 3121, Australia

Location

Western Health

St Albans, Victoria, 3021, Australia

Location

GenesisCare Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

Location

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamideRadiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Shankar Siva

    Peter MacCallum Cancer Centre, Australia

    STUDY CHAIR

  • Arun Azad

    Peter MacCallum Cancer Centre, Australia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 24, 2020

Study Start

June 2, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

August 21, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)AU(15)