Clinical trial · Interventional
Hormone Therapy Followed By Internal Radiation Therapy in Treating Patients With Locally Recurrent Prostate Cancer
A Trial Of Neoadjuvant Androgen Supression And Dose Escalation Transperineal Ultrasound-Guided Brachytherapy For Locally Recurrent Prostate Adenocarcinoma Following External Beam Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as goserelin, leuprolide, flutamide, or bicalutamide may stop the adrenal glands from producing androgens. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining hormone therapy with internal radiation may be effective in treating locally recurrent prostate cancer. PURPOSE: Phase II trial to study the effectiveness of hormone therapy followed by internal radiation in treating patients who have locally recurrent prostate cancer following external-beam radiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- brachytherapy + radiation
- description
- Within 4 weeks after completion of androgen suppression, patients are sequentially enrolled to 2 different cohorts of brachytherapy. Cohort 1: Patients undergo initial-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Cohort 2: After a minimum of 1-year follow-up for all patients in cohort 1, if tolerance is acceptable, additional patients undergo higher-dose transperineal interstitial permanent prostate brachytherapy with iodine I 125 or palladium Pd 103. Quality of life is assessed at baseline, within 2 weeks prior to brachytherapy, every 3 months for 1 year, and then every 6 months for 2 years. Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
- interventionNames
- Radiation: brachytherapy
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- quality of life
- timeFrame
- Up to 10 years
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed locally recurrent or persistent prostate adenocarcinoma
* Locally recurrent disease
* Prostate-specific antigen (PSA) no greater than 10 ng/mL
* N0 and M0 (at time of initial diagnosis and at time of local recurrence)
* Lymph nodes must be negative or will be negative after nodal sampling or dissection
* More than 18 months after completion of prior external beam radiotherapy
* Must have had 1 of the following disease characteristics prior to external beam radiotherapy:
* T1-2a, Gleason score 2-6, and PSA no greater than 15 ng/mL
* T1-2a, Gleason score 7, and PSA no greater than 4 ng/mL
* T2b, Gleason score 2-6, and PSA no greater than 6 ng/mL
* Must have American Urological Association Symptom Index score no greater than 15
* Transrectal ultrasound-determined prostate planimetry volume no greater than 60 mL
* No pubic arch interference of more than 1/3 the prostatic volume determined by transrectal ultrasound or pelvic CT scan
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* Zubrod 0-1 OR
* ECOG 0-1
Life expectancy:
* At least 5 years
Other:
* No persistent late intestinal or bladder toxicity grade 2 or greater
* No other major medical or psychiatric illness that would preclude study
* No metallic hip prosthesis
* No other malignancy within the past 5 years except localized basal cell or squamous cell skin cancer
* No other concurrent illness that would limit life expectancy
* Suitable for spinal or general anesthesia
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Chemotherapy:
* No prior chemotherapy for prostate cancer
Endocrine therapy:
* At least 12 months since prior androgen suppression except goserelin or leuprolide with flutamide or bicalutamide begun within the past 30 days
Radiotherapy:
* See Disease Characteristics
* No prior external beam radiotherapy doses exceeding 71 Gy to the prostate
* No prior radionuclide prostate brachytherapy
Surgery:
* No prior transurethral prostate resection
* No prior prostatectomy or prostatic cryosurgery
* No prior bilateral orchiectomy
Other:
* No concurrent participation in another medical research study for prostate cancer treatmentReferences
Publications (0)
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