Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

— BiolenRT  

Official title:

Bicalutamide Implants (Biolen) With Radiation Therapy in Patients With Localized Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04943536
• Other study ID #: CP-002
• Secondary ID: ZIABC010850ZIABC
• Status: Recruiting
• Phase: Phase 1
• Start date: October 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Alessa Therapeutics Inc.
• Contact: Deborah Citrin, MD
• Phone: 301-496-5457
• Email: citrind[@]mail.nih.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma

Intervention

Drug:
• bicalutamide
localized anti-androgen therapy

Radiation:
• Stereotactic body radiation therapy
localized radiation therapy

Locations

Country	Name	City	State
United States	National Cancer Institute	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Alessa Therapeutics Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of replacing systemic androgen tx with targeted local delivery	Ability to successfully implant the prostate with Biolen and a lack of implant toxicity that interferes with the capacity to complete intended radiation therapy.	27 months
Secondary	Adverse Events	toxicity of localized delivery of bicalutamide	through 27 months
Secondary	MRI changes	prostate and tumor volume changes	baseline versus 8 weeks post biolen implantation and 6 months post RT
Secondary	Biochemical progression free survival	rate of biochemical progression free survival	24 months post RT