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

Sponsor

Alessa Therapeutics Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04943536

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Adenocarcinoma	Drug: bicalutamide Radiation: Stereotactic body radiation therapy	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Biolen+Radiation Therapy Localized single delivery of the Biolen implant (polymer + bicalutamide) with radiation therapy	Drug: bicalutamide localized anti-androgen therapy Radiation: Stereotactic body radiation therapy localized radiation therapy

Arm

Intervention/Treatment

Experimental: Biolen+Radiation Therapy

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

Drug: bicalutamide

localized anti-androgen therapy

Radiation: Stereotactic body radiation therapy

localized radiation therapy

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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:

National Comprehensive Cancer Network (NCCN) intermediate risk prostate cancer, OR
NCCN high risk prostate cancer due to Gleason Grade 4 or 5 AND refuses to receive systemic ADT, OR
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Institute	Bethesda	Maryland	United States	20894

Sponsors and Collaborators

Alessa Therapeutics Inc.
National Cancer Institute (NCI)

Investigators

Principal Investigator: Deborah Citrin, MD, National Cancer Institute (NCI)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alessa Therapeutics Inc.

ClinicalTrials.gov Identifier:

NCT04943536

Other Study ID Numbers:

CP-002

First Posted:

Jun 29, 2021

Last Update Posted:

Oct 8, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenocarcinoma

Bicalutamide

Study Results

No Results Posted as of Oct 8, 2021