Androgen Suppression Combined With Nodal Irradiation and Dose Escalated Prostate Treatment

Conditions

• Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Radiation — RADIATION
  46Gy / 23 fractions of EBRT to pelvis and prostate + LDR or HDR boost to prostate OR 25Gy / 5 fractions of EBRT to pelvis and prostate (ultrahypofractionation EBRT (SBRT)) + LDR or HDR boost to prostate. \+ Adjuvant ADT: Unfavourable Intermediate Risk: 6 months or High / Very High Risk: 24 months
• Radiation SBRT only — RADIATION
  25Gy / 5 fractions to pelvis + 40 Gy / 5 fractions to prostate (SBRT) (ultrahypofractionation EBRT (SBRT))
• ADT — DRUG
  Assigned at enrollment

Study Details

This study is being done to answer the following question: Is the strategy to give higher doses of radiotherapy treatment over a shorter period of time using special equipment and fewer treatments (also known as Stereotactic Body Radiation Therapy or SBRT) as effective as usual external radiation therapy given with a brachytherapy boost (which involves radiation sources inserted directly into the prostate)?

Key Dates

Start date

Apr 25, 2024

Status verified

Sep 2025

Primary completion

Oct 31, 2032

Completion

Apr 30, 2033

Study Design

Enrollment

710 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: EBRT + Brachy Boost
• Experimental: SBRT

Primary Outcome Measure

To compare the progression-free survival (PFS) of SBRT versus conventional EBRT plus brachytherapy boost defined as time to biochemical failure, initiation of salvage therapy, local-regional recurrence, distant progression, or death [ Time Frame: 8.6 years ]

Central Contacts

• Wendy Parulekar
  613-533-6430
  [email protected]

Locations (46)

Find similar trials in Antioch, CA

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