Prostate Adenocarcinoma
Conditions
Brief summary
This study will be undertaken to evaluate the feasibility of replacing systemic Androgen Deprivation Therapy (ADT) with targeted local delivery of an anti-androgen agent alone in patients in whom ADT + radiation therapy is indicated for the treatment of localized prostate cancer.
Detailed description
This study is a prospective, single-center, single-arm feasibility study. Up to 20 participants will be recruited to assess the safety and patient tolerance of Biolen for the localized delivery of bicalutamide into the prostate when delivered with radiotherapy. At baseline, patients will undergo multiparametric MRI of the prostate. Study participants will have placement of the drug eluting Biolen implants. At the 8 week timepoint, participants will undergo repeat multiparametric MRI. Participants will receive standard of care radiation therapy on weeks 9-11 and will be followed through 2 years post radiation. A third and fourth multiparametric MRI will be performed at 6 and 24 months after completion of radiation. Clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits. Following completion of follow-up or removal from protocol, patients may be offered enrollment on long-term follow up protocols.
Interventions
DRUGbicalutamide
localized anti-androgen therapy
RADIATIONStereotactic body radiation therapy
localized radiation therapy
Sponsors
Alessa Therapeutics Inc.
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with biopsy proven localized prostate cancer in whom prostate radiation and ADT is appropriate therapy (such as Intermediate Risk localized prostate cancer) * Patients must have at least 1 MRI detected; biopsy proven prostate cancer. * Patients diagnosed as one of the following: 1. National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer, OR 2. NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR 3. NCCN high risk prostate cancer due to Prostate Specific Antigen (PSA) \> 20 AND refuses to receive systemic ADT. * Age \>18 years.
Exclusion criteria
* NCCN high risk patients eligible for treatment with systemic ADT who do not refuse systemic ADT. * Patients receiving prior radiotherapy or surgery for prostate cancer. * Patients receiving prior or ongoing ADT. * Study participant unwilling or unable to undergo MRI, including patients with contra-indications to MRI, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc. * Use of 5 alpha reductase inhibitors (e.g. Finasteride or Dutasteride) within 3 months of screening or total use within the last two years prior to screening of \> 3 months. * Prostate volume more than 80 cc at prior MRI imaging. * International Prostate Symptom Score ≥ 20.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of replacing systemic androgen tx with targeted local delivery | 27 months | Ability to successfully implant the prostate with Biolen and a lack of implant toxicity that interferes with the capacity to complete intended radiation therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | through 27 months | toxicity of localized delivery of bicalutamide |
| MRI changes | baseline versus 8 weeks post biolen implantation and 6 months post RT | prostate and tumor volume changes |
| Biochemical progression free survival | 24 months post RT | rate of biochemical progression free survival |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDeborah Citrin, MD
National Cancer Institute (NCI)
Outcome results
None listed