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Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)

ConditionsProstate AdenocarcinomaCastration Sensitive Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorOntario Clinical Oncology Group (OCOG)

About this trial

The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma) treated with definitive or salvage radiotherapy ≥ 2 years or more before enrollment.

Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest/abdomen/pelvis) with ≤ 5 metastases cumulative on all imaging, including MRI and PSMA-PET.

All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.

After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng/ml;

Disqualifiers

Age < 18.

ECOG Performance Status ≥3.

PSA ≥ 20 ng/ml.

Treatment with ADT within 2 years from study enrollment or treatment with any androgen receptor axis within 6 months from study enrollment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Recurrence-directed therapy (RDT)

    Radiation

    RDT options include radiotherapy or surgical resection.

  • ELIGARD 22.5mg

    Drug

    ADT in the form of ELIGARD 22.5 mg every 3 months for a total of 12 months.

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: Recurrence-directed therapy (RDT) + ADT x 12 monthsExperimental treatment 2 interventions
Group B: Recurrence-directed therapy (RDT) aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite progression free survival

Biochemical, radiological or clinical progression \[composite PFS (cPFS) event\]

Time frame
Time from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up.

Secondary outcomes

1

Disease progression

Disease progression: time to biochemical progression (bPFS) (proportion of bPFS events); Disease progression: proportion of conventional-imaging based progression (rPFS) (proportion of rPFS events); Disease progression: proportion with eugonadal progression (egPFS)

Time frame
Time from date of randomization, until the date of progression or death occurring up to the 36 month follow-up.
2

Time to initiation of tertiary therapy;

Any non-protocol treatment given for prostate cancer after protocol-specified intervention.

Time frame
Time of initial therapy to 36 month follow-up.
3

Proportion of patients that develop castrate-resistant prostate cancer (CRPC)

Proportion of patients that develop castrate-resistant prostate cancer (CRPC)

Time frame
During the 36 month follow-up.
4

Overall survival.

Overall survival.

Time frame
During the 36 month follow-up.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ontario Clinical Oncology Group (OCOG)

Lead sponsor

Source ClinicalTrials.gov
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