Prostate AdenocarcinomaPhase 2RATIONALNCT06654336
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)
A Phase 2 study testing Recurrence-directed therapy (RDT) and ELIGARD 22.5mg in people with Prostate Adenocarcinoma and Castration Sensitive Prostate Cancer, run by Ontario Clinical Oncology Group (OCOG) at 5 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Adenocarcinoma, Castration Sensitive Prostate Cancer
- What is being tested?
- Recurrence-directed therapy (RDT) and ELIGARD 22.5mg
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 5 sitesCanada
- Study dates
- 6 May 2026to Jun 2031
- Phase
- Phase 2
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
- 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.
- Note: Patients with conventional imaging M1 oligometastatic CSPC, who have no more than 5 metastatic sites in all imaging modalities including MRI and PSMA-PET, will be accepted for study enrollment.
- All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator.
- Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:
- After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng/ml;
- After prostatectomy and adjuvant/salvage radiotherapy, with PSA ≥ nadir + 0.2ng/ml.
Who cannot join
- 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.
- Prior treatment with chemotherapy for prostate cancer or bilateral orchiectomy. Note: prior chemotherapy for a different type of cancer is allowed if the patient has been continuously disease-free for > 3 years.
- Intracranial or intrathecal metastasis.
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- Spinal cord compression, or spinal intramedullary metastasis.
- Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for > 3 years.
- Bilateral hip prosthesis, treated earlier with definitive prostate radiotherapy, who have evidence of local disease recurrence within the prostate and no option for salvage treatment with brachytherapy or surgery.
- Previous documented hypersensitivity to ELIGARD® or other GnRH agonist analogs of components of such preparations.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario
Theos Tsakiridis, Dr., 001-905-525-9140, tsakirid@hhsc.ca
Theos Tsakiridis, Dr.
- Recruiting
Jewish General Hospital
Montreal, Quebec, H1T2M4
Melanie Research Coordinator, 514-340-8222, melanie.criqui.ccomtl@ssss.gouv.qc.ca
Tamim Niazi, MD
- Recruiting
McGill University Health Centre (MUHC) - Glen Site
Montreal, Quebec
Dr Marie Duclos, MD, 514-934-8040, marie.duclos@muhc.mcgill.ca
- Not yet recruiting
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H8L6
Scott Morgan, MD
- Recruiting
University Health Network Princess Margaret Cancer Centre
Toronto, Ontario
Dr Aruz Mesci, MD, (416) 946-4501 ext. 4709, aruz.mesci@uhn.ca
About this study
Official title: Phase II Randomized Trial of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC).
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.
Read the detailed description
A multi-centre, open-label, phase II randomized clinical trial evaluating the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® compared to Recurrence Directed Therapy (RDT) alone in patients with previously localized prostate adenocarcinoma treated with definitive radiotherapy or with salvage radiotherapy after radical prostatectomy who experience biochemical recurrence and present with oligo-metastases (i.e., < 5 sites of metastases) on conventional imaging. Eligible and consenting patents will be randomized in a 1:1 fashion to either RDT alone (standard arm) or RDT +ADT (ELIGARD®) x12 months (experimental arm). During treatment study participants will be assessed for disease progression, development of castrate resistant prostate cancer (CRPC), acute and late genitourinary (GU) and gastrointestinal (GI) radiotherapy toxicity, the occurrence of adverse events, initiation of tertiary therapy, overall survival and quality of life through the completion of participant questionnaires. Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months from the date of randomization. The planned sample size is 162 study participants.
- Being tested
- Recurrence-directed therapy (RDT), ELIGARD 22.5mg
- Keywords
- Prostate adenocarcinoma, Castration Sensitive Prostate Cancer, Recurrent Oligo-metastatic Castration Sensitive Prostate CancerSPC, Andrigen Deprivation Therapy, Eligard, Recurrence Directed Therapy, Radiotherapy, Bio-chemical recurrence, Androgen Deprivation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recurrence-directed therapy (RDT)Radiation
RDT options include radiotherapy or surgical resection.
ELIGARD 22.5mgDrug
ADT in the form of ELIGARD 22.5 mg every 3 months for a total of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Recurrence-directed therapy (RDT) + ADT x 12 months | Experimental | Local, regional or distant oligometastatic RDT in addition to treatment with ADT for 12 months in the form of ELIGARD®. Receives: Radiation: Recurrence-directed therapy (RDT); Drug: ELIGARD 22.5mg |
| Recurrence-directed therapy (RDT) alone | Active comparator | Local, regional, and distant oligometastatic RDT. Receives: Radiation: Recurrence-directed therapy (RDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite progression free survival
Biochemical, radiological or clinical progression [composite PFS (cPFS) event]
Measured: Time from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up.
Secondary outcomes (8)
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)
Measured: Time from date of randomization, until the date of progression or death occurring up to the 36 month follow-up.
Time to initiation of tertiary therapy;
Any non-protocol treatment given for prostate cancer after protocol-specified intervention.
Measured: Time of initial therapy to 36 month follow-up.
Proportion of patients that develop castrate-resistant prostate cancer (CRPC)
Proportion of patients that develop castrate-resistant prostate cancer (CRPC)
Measured: During the 36 month follow-up.
Overall survival.
Overall survival.
Measured: During the 36 month follow-up.
Rate of early and late Grade 3 or higher GU and GI toxicity.
The rate of early and late Grade 3 or higher GU and GI toxicity will be assessed at baseline, 3, 6, 15 and 36 months. The CTCAEv.5.0 (> Grade 3, GI and GU) toxicity rates will be reported.
Measured: At 3, 6, 15 and 36 months.
Quality of life assessed by EORTC QLQ C30
Study participant reported quality of life utilizing the following measurement EORTC QLQ C30
Measured: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Quality of life assessed by EORTC QLQ PR25 questionnaire
Measured: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Quality of life assessed by EORTC QLQ PRT20 questionnaire
Measured: Completed by the study participant at scheduled follow-up visits (Months 3, 6, 15 and 36).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start6 May 2026
- Primary completionApr 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate AdenocarcinomaStudies 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
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Theos Tsakiridis, Dr., Principal investigator, McMaster UniversityJim Wright, Dr., Study director, Ontario Clinical Oncology Group (OCOG)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654336
- Sponsor's protocol ID
- OCOG-2024-RATΙONAL
- Acronym
- RATIONAL
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A complete de-identified patient-level data set will be made available to academic affiliated researchers for the purpose of meta-analysis or a newly proposed study. * Data will be made available following submission of a maximum 2-page proposal. The study Steering Committee will review and, if acceptable, provide approval of the request. * A signed data sharing access/transfer agreement will be required between the requesting party and OCOG. * Authorship of publications to include the name of the study Principal Investigator. * The data will be provided as SAS datasets (as a CPT or XPT file). Any other format requests or additional statistical support may incur costs to the requestor. * Data will become available 12 months after publication by the study Principal Investigator, of the initial study results