BridgeMD
New treatment option for Prostate Adenocarcinoma
Official title 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)
ClinicalTrials.gov ID: NCT06654336
What this study is testing
What is ELIGARD 22.5mg?
ELIGARD 22.5mg is an investigational medicine, being studied as a potential treatment for prostate adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma)...
- Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest/abdomen/pelvis) with ≤ 5 metastases cumulative on all...
- 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;
You likely can't join if
- 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...
- Intracranial or intrathecal metastasis.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hamilton, Ontario, Canada
- Ottawa, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hamilton, Ontario, Canada; Ottawa, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.