Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Central Nervous System Depressants

Antineoplastic Agents

Reproductive Control Agents

Androgens

Anesthetics

Hormones

Leuprolide

Bicalutamide

Hormone Antagonists

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.

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.

Androgen deprivation therapy (ADT)

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.

Brachytherapy

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.

Hypofractionated pelvic External beam radiation

Daniel Gorovets, MD

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.

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

Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Time to distant metastases will be estimated from the date of enrollment until distant metastases

Using CTCAE v5.0. NCI Common Toxicity Criteria. The NCI scales are simple to complete and provide a means for assessing patient symptoms. Only the CTCAE v 5.0 will be used in toxicity grading.

Memorial Sloan Kettering Cancer Center

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

Brachytherapy boost with external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds (110Gy) or high dose rate (14Gy) with iridium-192) only to the prostate. Each center will choose the appropriate brachytherapy technique

Exclusive external beam radiotherapy. External beam radiotherapy of 46 Gy delivered to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.

Bras A: External beam radiotherapy of 46 Gy delivered with a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds from Bard (110Gy) or high dose rate (14Gy) with a iridium-192 source) only to the prostate. Each center will choose the appropriate brachytherapy technique. The number of seeds or needles will depend on the prostate's volume.

Brachytherapy boost with external beam radiotherapy

Bras B: External beam radiotherapy of 46 Gy delivered with photons and a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.

Exclusive external beam radiotherapy

Olivier CHAPET, MD

Julien BERTHILLER

Laurent VOTRON, MD

Yasser HAMMOUD, MD

Nathalie BONICHON-LAMICHHANE, MD

Laurence THOMAS, MD

Jean-Pierre MALHAIRE, MD

Marlon SILVA, MD

Gilles CREHANGE, MD

Michel BOLLA, MD

Pascal POMMIER, MD

Fabrice LORCHEL, MD

Naji SALEM, MD

Carmen LLACER MOSCARDO, MD

Didier PEIFFERT, MD

Laurent CHAUVEINC, MD

Jean-Michel HANNOUN LEVI, MD

Alain LABIB, MD

Christophe HENNEQUIN, MD

Martin HOUSSET, MD

Stéphane GUERIF, MD

Tan Dat NGUYEN, MD

Frédéric MALLET, MD

Renaud DE CREVOISIER, MD

Ahmed BENYOUCEF, MD

Guy DE LAROCHE, MD

Marius POP, MD

BACHAUD Jean-Marc, MD

Alberto BOSSI, MD

ARDIET Jean-Michel, MD

The aim of the present phase III study is two-folded: 1) to show a superiority of external beam radiotherapy combined with a brachytherapy boost versus exclusive external beam radiotherapy and 2) to evaluate the economic impact of each treatment.

The study includes 33 cancer centres, the inclusion time is of 2 years and the follow-up is of 5 years.

Medical and Economic Evaluation for Intermediate-risk Prostate Cancer

Medical and Economic Evaluation of an External Beam Radiotherapy Combined With a Brachytherapy Boost Compared With an Exclusive External Beam Radiotherapy for Intermediate-risk Prostate Cancer

Biochemical relapse is defined using the Phoenix definition of nadir of Prostate Specific Antigen + 2 ng/ml. This will be studied for both arms

The toxicities include: acute and late toxicities, sexual toxicities, the quality of life of the patients (CTCAE version 4.0)

The complete medical and economical evaluation of the strategies

Hospices Civils de Lyon

Adenocarcinoma

EBRT will be administered every 5 consecutive days for 5 consecutive weeks. This is standard of care practice for this therapy. This may be revised as applicable per treating physician discretion. The dose of radiation will be in accordance with standard clinical practice guidelines for the treatment of prostate cancer.

External Beam Radiation

HDR brachytherapy will be administered per standard clinical practice (per NCCN guidelines version 1.2020 for prostate cancer), however standard clinical practice may vary between clinicians. Therefore, the dose of 15Gy in 1 fraction and a set of dosimetry guidelines are to be followed for the purposes of this study. A diagnostic MRI will be co-registered with Transrectal Ultrasound (TRUS) to perform the HDR brachytherapy.

HDR Brachytherapy

The dosing and administration of ADT will be in accordance with the drug label for the drug(s) used for this purpose. Participants may receive ADT before and/or during the course of this study.

Androgen Deprivation Therapy

Song W

Chris Luminais, MD

This study is trying to find out if the combination of Androgen deprivation therapy (ADT), MRI guided high dose radiation (HDR) brachytherapy treatment (internal radiation implant procedure) and external beam radiation therapy (EBRT) treatments lead to less side effects. This study is also looking at patient outcomes, quality of life, and overall survival for patients receiving this treatment.

Androgen Deprivation Therapy (ADT) High-dose-rate (HDR) Brachytherapy External Beam Radiation Therapy (EBRT)

EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer

Prospective Trial of Combination External Beam Radiation Therapy and MRI-guided, Dose-differentiated High Dose-rate Prostate Brachytherapy Boost for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer

Grade 3 GU toxicity rate as measured by CTCAE v5.0

Greater than or equal to grade 3 GU toxicity rate as measured by CTCAE v5.0

GI and sexual toxicity as measured by CTCAE v5.0 and EPIC-26 survey results

Prostate-specific antigen (PSA) failure (nadir greater than 2ng/mL)

University of Virginia

Assistant Professor of Radiation Oncology

Goserelin

Androgen Antagonists

Flutamide

Androgen suppression with external beam radiation therapy followed by brachytherapy boost

Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2

LHRH agonist

flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks

antiandrogen

4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)

radiation therapy

Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy

Brachytherapy boost

Mark Hurwitz, MD

RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.

OBJECTIVES:

* Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer.
* Determine the safety of EBRT+BT in these patients.
* Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients.

OUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks.

Within 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer

Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer

Progression free and overall survival will be assessed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Shorter Course Hormone Therapy and Radiation for High-risk Prostate Cancer	NCT05100472	Prostate Cancer	Androgen depriv... Brachytherapy Hypofractionate...	18 Years -	Memorial Sloan Kettering Cancer Center
Medical and Economic Evaluation for Intermediate-risk Prostate Cancer	NCT02271659	Prostate Cancer	Brachytherapy b... Exclusive exter...	18 Years - 80 Years	Hospices Civils de Lyon
Medical and Economic Evaluation for Intermediate-risk Prostate Cancer	NCT02271659	Prostate Cancer	Brachytherapy b... Exclusive exter...	18 Years - 80 Years	Hospices Civils de Lyon
EBRT and HDR Brachytherapy for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer	NCT04465500	Prostate Cancer Prostate Adenoc...	External Beam R... HDR Brachythera... Androgen Depriv...	18 Years -	University of Virginia
Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer	NCT00006359	Prostate Cancer	LHRH agonist antiandrogen radiation thera... Brachytherapy b...	18 Years - 120 Years	Alliance for Clinical Trials in Oncology

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