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RecruitingLast updated: 12 February 2024

PRIMORDIUM: This phase III trial is evaluating whether radiotherapy and LHRH agonist are a more effective treatment when also combined with apalutamide (hormone therapy) in people with prostate cancerA Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, With an Observational Follow-up of PSMA-PET-Negative Patients

Clinical summary

Summary

This is a randomised, open-label trial which consists of two cohorts: interventional and observational. Within the intervention cohort, there are two groups: Group 1 (Active Comparator) will receive RT + LHRHa, and Group 2 (Experimental) will receive RT + LHRHa + Apalutamide. Eligible participants will undergo prostate-specific membrane antigen-positron emission tomography (PSMA-PET), whole-body Tc-bone scan, computed tomography (CT). Participants in Interventional Group 1 will receive RT with or without optional stereotactic body radiation therapy (SBRT), beginning 4 weeks after randomisation, along with LHRHa as a 3-monthly depot preparation within 3 days after randomisation and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomisation. Participants in Interventional Group 2 will receive RT with or without SBRT, beginning 4 weeks after randomisation, along with LHRHa as a 3-monthly depot preparation within 3 days after randomisation and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomisation. These participants will also receive 240mg of apalutamide starting within 3 days after randomisation, to be taken orally, once daily, for 180 days. Participants in the Observational Cohort will be those who are PSMA-PET-negative at screening. Data from this group will be collected in the course of routine clinical practice and will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status.

Conditions

This trial is treating patients with prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

III

Trial Acronym

PRIMORDIUM

More information

Trial Identifiers

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Trial sponsor

Janssen Pharmaceutica N.V., Belgium

Scientific Title

A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With PSMA-PET-Positive Hormone-Sensitive Prostate Cancer, With an Observational Follow-up of PSMA-PET-Negative Patients

Eligibility

Inclusion

  • Histologically confirmed adenocarcinoma of the prostate
  • Previously treated with radical prostatectomy with or without lymph node dissection and either: a) for biochemical recurrence after radical prostatectomy (RP): any post-operative prostate-specific antigen (PSA) measurement of less than (<) 0.1 nanogram/milliliter (ng/mL) within 12 months after RP and without any PSA greater than and equal to (>=) 0.1 ng/mL within the 4 to 8-week period after RP or b) for persistent PSA after RP: PSA >=0.1 ng/mL within the 4 to 8-week period after RP, confirmed by additional measurement at least 3 weeks later
  • Be able to swallow whole the study drug tablets or follow the instructions for admixing with apple sauce
  • Results of the Prostate specific membrane antigen-positron emission tomography (PSMA-PET) at screening as determined by blinded independent, central review (BICR), must be: PSMA-PET-negative for any prostate cancer lesions (that is, no loco-regional lesion and no distant lesions); or PSMA-PET-positive for at least one loco-regional (pelvic) lesion without distant extra-pelvic lesion; or PSMA PET- positive for at least one loco--regional (pelvic) lesion with extra-pelvic lesion(s).
  • High risk of developing metastasis defined as; a) for biochemical recurrence after RP: pathological Gleason score greater than or equal to (>=) 8 evaluated from prostate tissue specimen at radical prostatectomy, or prostate-specific antigen doubling time (PSADT) less than or equal to (<=) 12 months at the time of screening; b) for persistent PSA after RP: pathological Gleason score >=8, evaluated from prostate tissue specimen at radical prostatectomy
  • Participants with evidence of distant metastasis on screening PSMA-PET scan must have no evidence of prostate cancer metastases on screening CT/MRI of the chest/abdomen/pelvis, Technetium 99m [99mTc] whole-body bone scan. Participants with a single bone lesion on 99mTc whole-body bone scan should have confirmatory imaging by CT or MRI; if the confirmatory scan confirms the bone lesion, the participant should be excluded from the study. Conventional images (99mTc-bone scan and CT/MRI) from the screening will be evaluated locally before randomization
  • Eastern Cooperative Oncology Group Performance Status Grade 0 or 1

Exclusion

  • History of pelvic radiation for malignancy
  • Previous treatment with androgen deprivation therapy (ADT) for prostate cancer
  • Previously treated for biochemical recurrence (BCR) or persistent PSA after RP (previous surgical treatment of one or more loco-regional lesions is allowed)
  • Prior treatment with a CYP17 inhibitor (example, oral ketoconazole, orteronel, abiraterone acetate, galeterone) or any androgen receptor (AR) antagonist including bicalutamide, flutamide, nilutamide, apalutamide, enzalutamide or darolutamide and any other medications that may lower androgen levels (estrogens, progestins, aminoglutethimide, etc.), including bilateral orchiectomy
  • Known or suspected contraindications or hypersensitivity to apalutamide, Luteinizing Hormone-Releasing Hormone (LHRH) agonist or any of the components of the formulations
  • Prior chemotherapy for prostate cancer
  • Any evidence of prostate cancer metastasis on computed tomography/magnetic resonance imaging (CT/MRI) of the chest/abdomen/pelvis or 99mTc whole-body bone scan, at any time prior to screening

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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