Clinical trial NCT04943536: Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
Official title: Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Prostate Adenocarcinoma
Lead sponsor: Alessa Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-06-29
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of replacing systemic androgen tx with targeted local delivery
timeFrame: 27 months
Secondary outcomes:
measure: Adverse Events
timeFrame: through 27 months
measure: MRI changes
timeFrame: baseline versus 8 weeks post biolen implantation and 6 months post RT
measure: Biochemical progression free survival
timeFrame: 24 months post RT
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Deborah Citrin, MD
role: PRINCIPAL_INVESTIGATOR
References: