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) (RATIONAL)

Ontario Clinical Oncology Group (OCOG)

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Prostate Adenocarcinoma; Castration Sensitive Prostate Cancer

Treatments: Radiation: Recurrence-directed therapy (RDT); Drug: ELIGARD 22.5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT06654336

OCOG-2024-RATΙONAL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 162 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.

2. 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.

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

4. Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:

   1. After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng/ml;
   2. After prostatectomy and adjuvant/salvage radiotherapy, with PSA ≥ nadir + 0.2ng/ml.

Exclusion criteria

1. Age < 18.
2. ECOG Performance Status ≥3.
3. PSA ≥ 20 ng/ml.
4. Treatment with ADT within 2 years from study enrollment or treatment with any androgen receptor axis within 6 months from study enrollment.
5. 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.
6. Intracranial or intrathecal metastasis.
7. Spinal cord compression, or spinal intramedullary metastasis.
8. Prior malignancy (except non metastatic, non- melanomatous skin cancer) unless disease free for > 3 years.
9. 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.
10. Previous documented hypersensitivity to ELIGARD® or other GnRH agonist analogs of components of such preparations.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 2 patient groups

Recurrence-directed therapy (RDT) + ADT x 12 months

Experimental group

Description:

Local, regional or distant oligometastatic RDT in addition to treatment with ADT for 12 months in the form of ELIGARD®.

Treatment:

Drug: ELIGARD 22.5mg

Radiation: Recurrence-directed therapy (RDT)

Recurrence-directed therapy (RDT) alone

Active Comparator group

Description:

Local, regional, and distant oligometastatic RDT.

Treatment:

Radiation: Recurrence-directed therapy (RDT)