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Trial 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)
NCT ID:
NCT06654336
Condition:
Prostate Adenocarcinoma
Castration Sensitive Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Adenocarcinoma
Hypersensitivity
Recurrence
Leuprolide
Conditions: 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
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Recurrence-directed therapy (RDT)
Description:
RDT options include radiotherapy or surgical resection.
Arm group label:
Recurrence-directed therapy (RDT) + ADT x 12 months
Arm group label:
Recurrence-directed therapy (RDT) alone
Intervention type:
Drug
Intervention name:
ELIGARD 22.5mg
Description:
ADT in the form of ELIGARD 22.5 mg every 3 months for a total of 12 months.
Arm group label:
Recurrence-directed therapy (RDT) + ADT x 12 months
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 prostate cancer (romCSPC).
Participants will be assessed at standard of care clinic visits every 3 months. The
follow-up period is 36 months.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Juravinski Cancer Centre
Address:
City:
Hamilton
Country:
Canada
Contact:
Last name:
Theos Tsakiridis, Dr.
Phone:
001-905-525-9140
Email:
tsakirid@hhsc.ca
Investigator:
Last name:
Theos Tsakiridis, Dr.
Email:
Principal Investigator
Start date:
April 15, 2025
Completion date:
June 2031
Lead sponsor:
Agency:
Ontario Clinical Oncology Group (OCOG)
Agency class:
Other
Collaborator:
Agency:
Ontario Clinical Oncology Group (OCOG) - McMaster University
Agency class:
Other
Collaborator:
Agency:
TOLMAR PHARMACEUTIQUES CANADA, INC.
Agency class:
Other
Source:
Ontario Clinical Oncology Group (OCOG)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06654336
