Bicalutamide + Radiation Therapy for Prostate Cancer

(BiolenRT Trial)

Overseen By Theresa Cooley-Zgela, RN

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Alessa Therapeutics Inc.

Must be taking: Anti-androgens

Must not be taking: 5 alpha reductase inhibitors

Disqualifiers: Prior radiotherapy, Prior surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Deborah Citrin, MD

Principal Investigator

National Cancer Institute (NCI)

Eligibility Criteria

Men over 18 with intermediate or high-risk localized prostate cancer suitable for radiation and anti-androgen therapy, but who refuse systemic ADT. They must have MRI-detected, biopsy-proven cancer and not used certain medications recently. Men with prior prostate cancer treatments or severe urinary symptoms are excluded.

Inclusion Criteria

I have intermediate or high-risk prostate cancer and refuse hormone therapy.

I am older than 18 years.

I have prostate cancer that is still contained within the prostate and requires radiation and hormone therapy.

Exclusion Criteria

I haven't used medications like Finasteride or Dutasteride for more than 3 months in the last 2 years.

I am at high risk and open to hormone therapy for my cancer.

I cannot have an MRI due to a medical device I have or another reason.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline multiparametric MRI of the prostate and placement of Biolen implants

1 week

1 visit (in-person)

Treatment

Participants receive standard of care radiation therapy

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including multiparametric MRIs and clinical labs

24 months

Multiple visits (in-person)

Long-term follow-up (optional)

Participants may be offered enrollment on long-term follow-up protocols

Treatment Details

Interventions

• Bicalutamide
• Stereotactic Body Radiation Therapy

Trial Overview The trial is testing the use of Bicalutamide implants (Biolen) combined with Stereotactic body radiation therapy as an alternative to standard Androgen Deprivation Therapy in treating localized prostate cancer.

Participant Groups

Group I: Biolen+Radiation Therapy Experimental Treatment 2 Interventions

Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy

Bicalutamide is already approved in European Union, United States, Japan, Canada for the following indications:

Approved in European Union as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in United States as Casodex for:

• Metastatic prostate cancer

Approved in Japan as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Approved in Canada as Casodex for:

• Metastatic prostate cancer
• Locally advanced prostate cancer

Who Is Running the Clinical Trial?

Alessa Therapeutics Inc.

Lead Sponsor

Trials

3

Recruited

60+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+