A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-19

Study Completion Date

2026-10-19

Brief Summary

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The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.

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Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a phase II single arm trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hormone Therapy and Radiation

Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.

Group Type EXPERIMENTAL

Androgen deprivation therapy (ADT)

Intervention Type BIOLOGICAL

ADT will include bicalutamide 50 mg PO daily started 1-2 weeks before leuprolide 22.5mg IM or SQ delivered every 3 months x 2. Bicalutamide will be continued through radiation and then discontinued on the day of the last fraction. Leuprolide can be given at different doses, but must be given for a total planned duration of 6 months.

Brachytherapy

Intervention Type RADIATION

After approximately 3 months (+/- 1 month) of neoadjuvant ADT, patients will undergo general anesthesia for outpatient transperineal high dose rate (HDR) interstitial prostate brachytherapy implant.

Hypofractionated pelvic External beam radiation

Intervention Type RADIATION

Patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.

Interventions

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Androgen deprivation therapy (ADT)

ADT will include bicalutamide 50 mg PO daily started 1-2 weeks before leuprolide 22.5mg IM or SQ delivered every 3 months x 2. Bicalutamide will be continued through radiation and then discontinued on the day of the last fraction. Leuprolide can be given at different doses, but must be given for a total planned duration of 6 months.

Intervention Type BIOLOGICAL

Brachytherapy

After approximately 3 months (+/- 1 month) of neoadjuvant ADT, patients will undergo general anesthesia for outpatient transperineal high dose rate (HDR) interstitial prostate brachytherapy implant.

Intervention Type RADIATION

Hypofractionated pelvic External beam radiation

Patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Pathologically-proven diagnosis of prostate adenocarcinoma
* Clinical stage T3-4 or Gleason score 8-10 or PSA \>20 ng/ml

°If radiographic T3-T4 is the only high-risk factor, it must be "consistent with" or \>90% probability of having T3-T4 disease determined by the reading radiologist.
* Decipher genomic score ≤0.6
* Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
* Age ≥18
* KPS ≥70 or ECOG 0-2
* Estimated life expectancy \>5 years
* Baseline prostate volume ≤90 cc
* Baseline IPSS ≤20
* No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice
* Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration

Exclusion Criteria

* Regional lymph node or metastatic disease
* Prior pelvic radiation
* Prior prostate surgery (including TURP or cryosurgery)
* Prior history of inflammatory bowel disease
* Unable to undergo anesthesia or brachytherapy
* Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No